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stephenmccull · 3 years ago

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Pfizer Court Fight Could Legalize Medicare Copays and Unleash ‘Gold Rush’ in Sales

Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.

By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.

Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.

A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge’s ruling is expected any day.

“If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush,” government lawyer Jacob Lillywhite said in oral arguments last month.

Pfizer’s legal argument “is aggressive,” said Chris Robertson, a professor of health law at Boston University. “But I think they’ve got such a political tailwind behind them” because of pocketbook pain over prescription medicine — even though it’s caused by pharma manufacturers. Pfizer’s message, “‘We’re just trying to help people afford their drugs,’ is pretty attractive,” he said.

That’s not all that’s working in Pfizer’s favor. Courts and regulations have been moving pharma’s way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.

Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.

“It’s infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts,” said Michelle Mello, a professor of law and medicine at Stanford University. “Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights.”

Pfizer’s lawsuit, in the Southern District of New York, seeks a judge’s permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.

Letting pharma companies put money directly into patients’ pockets to pay for their own expensive medicines “does induce people to get a specific product” instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. “It’s kind of the definition of a kickback.”

Government rule-makers have warned against such payments since the launch of Medicare’s Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.

Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.

At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are “bona fide, independent” organizations that don’t match drugmaker money with specific drugs.

Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.

Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.

Under such arrangements, every $1 million channeled through a charity “has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government,” Andrew Baum, a Citi pharma stock analyst, wrote in 2017.

Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its “desire to put this legal matter behind us.”

The PAN Foundation and three other charities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.

PAN’s settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.

The 2019 PAN agreement related to “legacy matters” and “did not involve any of PAN’s current operations or disease funds,” organization CEO Dan Klein said via a spokesperson. “Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy.”

But legal troubles have hardly slowed the pharma-funded patient assistance business.

Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.

Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.

Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.

If Pfizer’s lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University’s Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department’s inspector general estimated.

Pharma companies can “learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient,” Anderson said. “You get a huge return.”

Pfizer argues that its proposal, which the HHS inspector general called “highly suspect” in an advisory opinion before the company filed its lawsuit, is legal and sensible.

“Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs,” company spokesperson Steven Danehy said.

But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS’ Office of Inspector General declined to comment.)

Pfizer has “priced itself out of the market,” he said. The company is seeking to “do something that’s unprecedented, to upend decades of settled law and agency guidance” to boost sales of “what is the most expensive cardiovascular drug ever launched in the United States.”

After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company’s contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.

But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.

A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren’t identified.

A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.

Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.

The federal kickback law doesn’t mention copay assistance charities “and wasn’t designed with these programs in mind,” said Mello, of Stanford. Pfizer’s lawsuit “should be a loud, clanging call to Congress” to explicitly define drug assistance subsidies as illegal kickbacks, she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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worldofartshop · 6 years ago

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thisdaynews · 5 years ago

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What you missed while watching the impeachment, Week 2

New Post has been published on https://thebiafrastar.com/what-you-missed-while-watching-the-impeachment-week-2/

What you missed while watching the impeachment, Week 2

Over at the Pentagon, the military’s intelligence arm warned that the administration’s pullout from Syria could aid the revival of ISIS.

Oh, and the government won’t shut down for now — no small accomplishment for a Congress that subjected Washington to the longest shutdown in history earlier this year.

These breakthroughs might have been front-page fodder in a different news cycle, but not in Trump’s Washington this week. That’s why POLITICO’s policy journalists are here with your quick fix of other news, for part 2 of our take on what happened in Washington while you were watching the impeachment.

Democrats and Republicans agreed on an asbestos ban

Thirty years after EPA tried and failed to ban asbestos, House Democrats and Republicans agreed on legislation to prohibit the carcinogenic fiber. The deal on Tuesday got bipartisan support before the House Energy and Commerce Committee, 47-1, after lawmakers agreed to a temporary exemption for the only industry that still uses asbestos, chlorine manufacturing, giving companies time to switch to newer technologies.

Ultimate passage into law is still uncertain, but this is the most promising outlook that asbestos ban legislation has enjoyed in years. The bill’s advancement follows a court ruling that faulted the EPA for not studying the health risks of “legacy” chemicals such as the asbestos insulation present in millions of homes and other buildings.— Alex Guillén

The Pentagon’s spy agency said Trump’s Syria pullout helped ISIS

The withdrawal, along with Turkey’s cross-border incursion to fight the Kurds, allowed ISIS to “reconstitute capabilities and resources within Syria and strengthen its ability to plan attacks abroad,” the quarterly report from the lead inspector general on the U.S. military campaign against ISIS said.

“The [Defense Intelligence Agency] also reported that without counterterrorism pressure, ISIS will probably be able to more freely build clandestine networks and will attempt to free ISIS members detained in [Syrian Democratic Forces]-run prisons and family members living in internally displaced persons … camps,” the inspector general added.— Connor O’Brien

Washington: Shutdown-free for another month

Congress cleared a short-term spending bill that will keep the government open for four additional weeks, diminishing the chances of a paralyzing governmentwide shutdown before Thanksgiving but also punting a tough decision on border wall spending.

Trump signed off on the bill, which runs through Dec. 20, since it doesn’t impose new restrictions on his border wall spending. Congressional leaders still lack a fiscal 2020 funding plan beyond the new deadline. Protracted fights over Trump’s border wall dominate the spending talks and impeachment proceedings threaten to consume Congress through January.— Caitlin Emma and Jennifer Scholtes

The EPA rescinded Obama-era chemical safety requirements

The EPA is weakening a chemical safety rule issued by the Obama administration in response to the West Texas fertilizer facility explosion in 2013 that killed 15 people. The rule — which covers 12,500 facilities ranging from oil refineries to chemical plants to food and beverage manufacturers — frees companies from more rigorous mitigation and safety preparation requirements. And it no longer requires the owners of chemical plants, refineries and other industrial facilities to publicly release data on the chemicals they store on-site.

The agency argued that the cost of those provisions outweighed potential benefits, added new burdens on facilities also subject to separate federal workplace safety standards and raised concerns about terrorists’ access to data. But environmentalists and unions have complained that the rollback will leave workers, especially firefighters and other first responders, at risk.— Alex Guillén

The Labor Department abandoned plans to roll back safety protections for teens

Teenagers were banned from working some types of health care jobs. The Labor Department scrapped a controversial proposal eliminating protections for teens operating patient lifting devices in nursing homes and hospitals. The idea was billed as an effort to expand apprenticeship opportunities in the health care industry. But worker safety groups said it would allow teens to perform “one of the most hazardous jobs in the nation.” Democrats also questioned whether the agency violated its data quality guidelines by relying on a SurveyMonkey poll with fewer than two dozen respondents to justify removing the protections.— Rebecca Rainey

Trump’s FDA nominee dodged tough questions on vaping restrictions

The new pick to lead the Food and Drug Administration skated through a Senate committee hearing Wednesday, despite declining to endorse harsh e-cigarette regulations and occasionally pleading ignorance on topics managed by the vast agency. Both Democrats and Republicans closely questioned nominee Stephen Hahn, a cancer doctor, on how he would handle vaping amid concern that the Trump administration is backing away from a crackdown on flavored vapes targeted at children. Hahn said he will put patients first but stopped short of committing to flavor bans. Republicans are aiming to install him by the end of the year. —Sarah Owermohle

Another marijuana bill was a hit in a House committee

The House Judiciary Committee advanced a bill that would make marijuana legal at the federal level and let states to make their own decisions regarding the drug. It would also scrub criminal records for certain marijuana-related federal crimes and create a grant program to help people arrested for marijuana offenses get launched in the legal market. “Look, I have never been happier that Chairman [Jerry Nadler] got sidelined on impeachment, because it appears he’s been given the time to work on an excellent cannabis bill,” Trump ally and marijuana supporter Rep. Matt Gaetz (R-Fla.) said on the eve of the historic vote. “If he gets sidelined again, who knows — maybe we’ll get an asylum bill.” Despite the committee vote, the bill may face six more committees before it can be scheduled for a House floor vote. And its future in the Senate is pretty uncertain given Majority Leader Mitch McConnell’s promise that he would not consider any marijuana legalization legislation. And this bill doesn’t have the same kind of House GOP backing that legislation that would give cannabis businesses access to financial services had when it passed the chamber in September.— Natalie Fertig

Regulators helped create a new big bank

A merger between BB&T and SunTrust, the largest bank union since the 2008 financial crisis, got the greenlight Tuesday, clearing the way for the two lenders to become the sixth-largest retail lender in the country. The Federal Reserve and the Federal Deposit Insurance Corp., signed off on the deal, even as the Fed dinged SunTrust for past “unfair and deceptive practices,” problems that the new bank will have to resolve.

The merged bank will be named Truist, with more than $453 billion in assets — smaller in size than only JPMorgan Chase, Bank of America, Citigroup, Wells Fargo and U.S. Bank — and with 2.6 percent of all U.S. deposits. The Justice Department signed off on the proposed merger earlier this month after the lenders agreed to sell more than two dozen branches to resolve antitrust concerns.— Victoria Guida

FCC settles big fight over the next generation of wireless technology

One of the most intense lobbying feuds over wireless spectrum in recent memory came to an end this week when the Federal Communications Commission announced it will auction off airwaves in the so-called C-band to get them into the hands of wireless providers. The wireless industry says this slice of the spectrum is crucial for rolling out ultrafast 5G services — but the decision marks a defeat for satellite companies that now hold the airwaves and wanted to sell them privately.

The satellite companies had contended that a private sale would be faster than a public auction. But it also could have meant less oversight and more revenue going to the firms instead of the U.S. Treasury.

The issue became so heated that Trump at one point got involved — and Sen. John Kennedy (R-La.), who favored the public auction option, warned that Americans would be monumentally “screwed” if foreign satellite companies ran the sale. Now the pressure will be on FCC Chairman Ajit Pai to set up and fast-track the auction in 2020 as the U.S. vies with China and other nations for 5G supremacy. —John Hendel

Trump is considering picking a new trade fight with Europe

Trump administration officials are looking at whether to start a new trade investigation against the European Union as the chance to hit the bloc with car tariffs appears to have passed, according to multiple people briefed on the issue. It would mean European auto imports wouldn’t be subject to duties out for national security reasons, but the EU — and its trade practices — would face a much broader inquiry, the people said.

“What it would do is it would create a situation that for another year would give the president leverage over the EU,” said a former administration official.

Trump was supposed to make a decision by Nov. 14 on whether to take action against imports of automobiles and auto parts from the EU. But with the deadline passed, questions are now being raised over whether he can continue using Section 232 of the Trade Expansion Act of 1962 to take any future tariff action. The previously little-used provision allows the president to impose trade restrictions if imports are considered a threat to national security.

Instead, a broader so-called Section 301 inquiry would examine whether trade policies impose unjustifiable burdens or restrictions on U.S. commerce. If an investigation finds that practices do so, Trump could slap tariffs on various imports from Europe. He has used just such a probe to slap duties on billions of Chinese goods. —Adam Behsudi and Doug Palmer

#Foreign #impeachment #Politics #watching

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bountyofbeads · 6 years ago

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https://www.delish.com/food-news/amp25939756/government-shutdown-affecting-food-drink-stamps-fda/?__twitter_impression=true

@maddow @chrislhayes 42 million Americans rely on SNAP benefits to out food on their tables. Countless businesses rely on the $5B of SNAP spent in stores every month. SNAP for March is at risk in the shutdown(A GOP WET DREAM, THEY WOULD PREFER TO SHUTTER ALL THESE AGENCIES) .PLEASE SHARE with your followers TY 🙏🙏🙏

The Government Shutdown Has Gone On So Long There's Fear Of Food Stamp Funding Running Out By March

States are now warning recipients to budget their benefits.

by TESS KOMAN |Published JAN 18, 2019 | Delish | Posted January 21, 2019 |

The stats about the current government shutdown are staggering: There are hundreds of thousands of people either not working or doing so without pay. It's now officially the longest shutdown in U.S. history. Major trusted outlets proclaim every day there is "no end in sight."

Here's what isn't being broadcast so widely, though: The partial government closure is affecting what you consume on an everyday basis. While federal employees are furloughed (meaning they're temporarily laid off), food safety checks aren't happening as often as they usually do. Food stamp and child nutrition programs can only be sustained so long until their current funding runs out. Even that influx of crazy new summer ale flavors you look forward to each summer? That may very well be held up, too.

Don't think any of that affects you? The prices of your groceries will soon slowly begin to rise, too. You eat food, don't you? The shutdown affects all facets of what we consume. Here’s how.

Not all necessary food safety inspections are happening.

The Food and Drug Administration initially halted safety inspections upon the announcement of the shutdown on December 22. But as of Tuesday, some employees are resuming their work without pay. The fact that food wasn't being checked for harmful bacteria panicked people, but the organization (the same one that’s had a lot of play over the past year from a strikingly high number of food recalls) was quick to clarify they would soon be back to conducting the most essential of inspections as usual. Since Tuesday, many FDA inspectors who’d been out since the beginning of the shutdown started doing just that: resuming said inspections without pay.

FDA Commissioner Scott Gottlieb continues to assure the public that though there’s less personnel working on inspecting high-risk foods like lettuces and soft cheeses (and though they’re currently working unpaid), the men and women doing the inspections are “outstanding” and “on the job.” That’s reassuring…to a point. “The FDA is currently restricted in inspection of plants,” says Dr. Simon Shane, whose degrees include a British Fellow of the Royal College of Veterinary Surgeons, Bachelor of Veterinary Science, Ph.D, Master of Business Leadership, and certification from the American College of Poultry Veterinarians.

“‘THEY’RE CERTAINLY NOT DOING ANY ELECTIVE WORK. THEY’RE JUST DOING THE BARE MINIMUM…’”

That’s where all the alarmist “Foods You Should Avoid During The Shutdown” pieces you keep seeing are coming from. “They’re certainly not doing any elective work. They’re just doing the bare minimum,” Shane tells Delish.

The largely shuttered United States Department of Agriculture [USDA] also plays a big role in other inspections, though those have remained generally consistent throughout the shutdown: “[The Food Safety and Inspection Service] is still working effectively for red meat and poultry,” Shane explains. All of those inspections are considered essential and high-risk. Still, 11 percent of the staff responsible for those and egg-related inspections have been and remain furloughed.

Beer, wine, and liquor applications are entirely halted.

If your primary concern when it comes to drinking is whether or not you’re stocked with Natty Light, the shutdown won’t really affect you. Where it does come into play is with craft brewers, wine makers, and anyone else affiliated with the alcohol industry.

One of the agencies impacted by the partial government closure is the Alcohol and Tobacco Tax Trade Bureau (TTB), which has been closed since the beginning of the shutdown. They regulate the entire alcohol and tobacco industry, and anything companies need in order to sell beer, create new beer, or label beer goes through them. That means both existing “breweries and breweries in planning are impacted,” Federal Affairs Manager of the Brewer’s Association Katie Marisic tells Delish. And when an industry responsible for $26 billion in retail sales last year alone gets held up, so do all the people who depend on it.

Each of the 7,100 craft breweries in the U.S. has a big impact on its supply chain, “whether that’s farming or manufacturing or retail.” And while Marisic can’t speak to whether or not those who help supply and support breweries are feeling the effects of the shutdown yet, she does know they inevitably will if the TTB can't process all that’s submitted to them. Some perfectly good beer that requires TTB allowance for being sold outside its brewery and/or state is just “sitting in vats waiting for that approval to come,” meaning breweries are sitting on product. Some perfectly laid product plans for seasonal drinks might not be processed until it’s too late. Basically, whatever the summer equivalent of eggnog vodka, magnums of beer, and pumpkin ales are, they may not be out during the summer.

Wine production is looking better—for the moment. “So far, there is not a major impact, and the industry has some breathing room,” the Wine Institute’s Gladys Horiuchi says. “Wines (such as early release whites) are usually the first to be bottled from last year’s harvest, and a lot depends on where wineries happen to be in their bottling cycle.” That said, “there will be delays for new labels if this shutdown continues for a longer time. Wineries who need new label approval are being encouraged to submit applications online to get into the queue for when TTB reopens.”

According to the Brewer’s Association, the TTB processed 34,166 applications last year for new labels on malt beverages alone. (The number of wine and spirit label applications submitted in 2017 wasn’t immediately clear.) The last time a government shutdown was long enough to warrant any sort of significant federal backlog in alcohol labeling, bottling, and approval processes, the number of permits being submitted was markedly lower. The industry officially became the largest it'd ever been in 2015, but Marisic explains the TTB's staff also grew, which, until now, meant there hadn't been long turnarounds on approvals: "It’s hard to figure out how much of an impact this will have [on how quickly approvals are back up and running], but it’s also hard to compare to 2013 because so much has changed.”

"'THERE ARE ONLY THREE CONGRESSIONAL DISTRICTS THAT DON’T CURRENTLY HAVE INDEPENDENT BREWERIES LOCATED IN THEM.'"

What’s not hard to compare is the unmitigated ubiquity of the small beer business across the country: “There are only three Congressional districts in our country that don’t currently have small and independent breweries located in them,” Marisic confirms. “So this has the ability to impact communities and small businesses all across the country.”

The food stamp-dependent have begun to worry.

Each month, the USDA distributes benefits to 19 million householdsacross the country that allow them to buy food; there are more than 38 million people who depend on this Supplemental Nutrition Assistance Program program (SNAP, or what’s commonly referred to as “food stamps”). When the government shut down, the funding appropriated for SNAP didn’t disappear, but there's also no guarantee it’ll continue to come through monthly either.

At the moment, all those who participate in SNAP or are newly applying for its benefits will receive their money in January, and because of the shutdown, February funds will be distributed earlier in the month than usual. The early issuance will make sure everyone who needs the funding for the whole month of February gets it, as some states distribute the money at all different times of the month.

What’s left after that is an approximately $3 billion contingency reserve that’ll be dipped into to ensure benefits continue into February. What happens next—will the remainder of that reserve be used up to distribute money to these low-income households in March?—isn't clear.

An expert in the field confirms to Delish there's no precedent for a situation like that and that it's only the Department of Agriculture and the administration who'd be able to answer that question. There is a world where if there is no appropriation for the programs, there is no program at all. Even after the government re-opens, if the law that re-opens it doesn't include funding for SNAP, there would just not be any authority for the government to fulfill those benefits, though the source hesitates to say so.

States have begun to issue statements to SNAP recipients encouraging them to not spend their early-issued benefits on a lot of food all at once. Instead, they ask people to spread the money out evenly over the course of the month.

The only other situation this expert can point to as an example of why states would issue benefits early like this? Natural disasters. The expert can only think of times when states that've anticipated hurricanes have preemptively issued benefits so people can buy food the second their stores are re-opened and they're able to get to them.

Separately, child nutrition programs (the ones that ensure kids get school breakfasts and lunches as needed) and Special Supplemental Nutrition Programs for pregnant and/or breastfeeding mothers face similar uncertainty at the moment. Though they’re separate programs, they’ve only currently received secure funding through March.

Farmers don't have access to the information they need to grow crops.

The USDA National Agricultural Statistics Service serves as a primary resource for farmers and traders to project pricing of crops, and—wait for it—it's not functioning right now. Shane calls the report one of the most accurate and impartial sources to exist in this realm. And while people can turn to other similar sources (the World Agricultural Supply and Demand Estimate, the Chicago Mercantile Exchange, etc.) so “they’re not in the dark [when it comes to what they should plan to be planting], that information isn’t necessarily as complete or maybe not as accurate” as it would be if they have access to the NASS as usual.

“'PEOPLE AREN’T MAKING ANY MISGUIDED DECISIONS JUST YET, BUT IF THE SHUTDOWN GOES ON FOR MUCH LONGER, THEY’LL BE FORCED TO.'”

Not having the most complete picture is one of many reasons the country may see inflated grocery prices down the line. It means that right now, farmers and producers are “in a holding pattern,” a longtime food quality assurance professional who agreed to speak on background tells Delish: "People aren’t making any misguided decisions just yet about their crops or quantities for the year, but if the shutdown goes on for much longer, they’ll be forced to." That, in turn, leads to too much of some crops and not enough of others. That is what gives us $6 heads of lettuce, or whatever.

More urgently, though, it’s the inability to secure a federal loan right now that’s holding people up from executing their 2019 production plans: “If people need loans to, for example, buy the chickens they need to produce eggs or buy the seeds they need to plant crops, it could really throw off their plans,” says the quality insurance professional. Shane agrees the lack of security around funding for farmers could be the start of problems to come: “They need to know how much money they’re going to be given so they can make arrangements for planting in a couple of months. There’s a lot of anxiety and a lot of problems there.”

That said, Shane can’t imagine the shutdown will last much longer, meaning producers will not only have access to their usual stats again soon, but also that they’ll know their situations around funding. That said, “don’t forget—there’s going to be a catch-up. If magically this were to be resolved tomorrow [laughs], there are a lot of things that didn’t happen [during the shutdown], and they’ll have to catch up” with all the applications for funding and requests for help.

Federal workers are guaranteed to be back-paid for the shutdown. Federal contractors are not.

Among the hundreds of thousands of furloughed government workers who’ve been asked to come back to work without pay—or who’ve been working the whole time and won’t be compensated retroactively—are federal cafeteria workers. There are many who aren’t unionized, but those who do belong to a union are generally part of UNITE HERE. According to the union, they represent about 500 federal food workers, most of whom make about $30,000 a year before taxes.

A bill proposed by Maryland Democratic senators has been passed since the shutdown began, and it ensures full-time federal workers will be paid back for this period of time. That bill, which President Trump signed into law on Wednesday, did not cover low-wage contractors who’ve been furloughed or had their hours severely reduced, though.

. Also on Wednesday, Democratic Minnesota Senator Tina Smith introduced a bill to try and ensure those same contractors would be back-paid for the time they worked during the partial government shutdown. At the time of this post, there is no guarantee they will be paid.

We will update this story with incoming information as the shutdown proceeds.

#donald trump #u.s. news #politics #trump administration #president donald trump #trump #trump scandals #politics and government #public health #white house #borderwall #must reads #trumpshutdown #endtheshutdown

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number06fan · 6 years ago

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How the Government Shutdown Effects Food Safety

With the government shut down entering its 18th day, the third longest of twenty-one shutdowns on record, people are starting to wonder what that means for agencies like the FDA and USDA. There have been highly publicized effects of the shutdown, like the trash in public parks or the Federal employees getting a jump start on applying for unemployment benefits. But every unfunded agency had to make some difficult calls as they prepared for the possibility of shut down. Many services are invisible to the public eye until they fail. Wonder what that means for our food? Here is how the government shutdown effects food safety.

The FDA and the USDA are the agencies which are responsible for regulating the integrity of our food supply; they are kind of important and—at the moment—only partially functional.

What really happens in a shut down?

The parts of the government which have not yet received funding from Congress, though an appropriations bill, have to shut down. Sort of. Due to the complexities of services provided, and the reality of operational mandate, various government agencies must make a plan for how to keep the world from utterly grinding to a halt or the country being vulnerable while the elected officials sort things out. Agencies must choose which functions are important enough to exempt from furlough. This means they require a skeleton crew to continue coming to work even though they cannot pay them until some form of budget is passed allowing these exempt staff to be paid. Because of when this particular shut down fell in the pay cycle, no one has missed a paycheck yet. But if the shut down continues, they may.

The skeleton crew protecting you

You’ll be happy know that the USDA’s food safety division, Food Safety and Inspection Service (FSIS) is continuing inspections of the country’s meat, siluriform (catfish and similar fish), poultry, and egg supplies. According to the USDA-Food Safety and Inspection Service Operations Plan for “Absence of Appropriations,” the “daily on-site inspection presence, regulatory enforcement and product testing in the laboratories” will continue because they are “necessary to protect life.” FSIS works hard to combat the spread of E. coli, Listeria monocytogenes, Salmonella, and Campylobacter

Essentially, the inspectors continue reporting to work as usual. Except without any non-exempt support personal, and with the real possibility that their next paycheck will be late, or never come. Traditionally, when Congress gets around to passing a budget, they back pay everyone—both the furloughed workers and the exempt staff. Since they must vote on it and trust for elected officials is never all that high there is always anxiety that they will not pay the government staff, which in turn whips the media into a fervor.

In contrast to the USDA, the FDA, which is part of the U.S. Department of Health and Human Services (HHS), will be suspending most of its enforcement activities. HHS has furloughed roughly 24% of its staff. They are keeping up some research, inspecting imported foods, emergency monitoring and response for toxic chemical exposures, hazardous leaks and spills, environmentally related poisons, as well as acts of terror or natural disasters. Other major projects were not affected by this shut down.

The FDA is continuing activities supported by user fees, as well as emergency response and criminal and civil investigations. This includes continuing to review data to determine potential health risks, manage high risk recalls, food-borne illness or other outbreaks. Inspections, as stated, are largely on hold. “FDA would be unable to support some routine regulatory and compliance activities. This includes some medical product, animal drug, and most food related activities. FDA will also pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.” These are the inspections looking for insects, E. coli, and Salmonella, among other things, in facilities processing romaine lettuce, and cake batter.

The FDA is poised to manage any outbreaks, but no longer poised to prevent them. As you can imagine, they aren’t any happier about it than you are.

According the Washington Post, the FDA oversees roughly 80% of the country’s food supply. The FDA is currently working on a plan to reinstate some inspections as early as next week regardless of funding. They hope to resume inspecting higher risk facilities, such as those with a history of problems, or those which process seafood, vegetables, or soft cheeses. FDA Commissioner Scott Gottlieb said in an interview that after cancelling fifty high risk inspections he is seeking authority to bring 150 furloughed inspectors back to work.

Again, this would inspectors reporting to work, now exempt from furlough, but still receiving no paycheck until Congress passes a budget.

This is hardly an ideal situation. Risk management has been thrown into disarray.

What can you do?

You can and should contact your legislators to encourage them to reach a compromise quickly, so they keep the country out of danger. This might result in a quicker resolution to the stalemate. In the meantime, you can also exercise caution when cooking and shopping.

Inspections are ongoing for meat, siluriformes, poultry, and eggs, but not for soft cheeses, shellfish, and other processed foods. Even if you normally cheat a little and swipe some raw cookie dough or brownie batter, don’t do it right now. Without facility inspections, the probability of infected flour is higher.

Cook as much of your food as possible. Raw vegetables are an excellent nutrition source, and if you are able to source them locally or from an otherwise trusted provider, that’s fantastic. Otherwise, this might be a great time to just cook all your vegetables. Conveniently, it’s winter, so most of the country is experiencing cold weather and cooking and eating hot veggies isn’t the burden it would be in summer. Many soft cheeses are also good cooked, so if you have a burning need for soft cheese after the shutdown, you should check out some recipes before taking the plunge (baked brie, for example, is great).

Make sure you are familiar with the safe food temperatures provided by the FDA, and also with some of the basic symptoms and high-risk groups for food borne illnesses. Since all the agencies are still staffing emergency response, still keep the packaging of guilty food items and report any illness. (You can call the USDA at 1-888-674-6854 if you think the illness was caused by meat, poultry or eggs. You can call the FDA at 1-866-300-4374 for all other foods.)

By: Abigail Cossette Ryan, Contributing Writer (Non-Lawyer)

The post How the Government Shutdown Effects Food Safety appeared first on Lange Law.

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jakehglover · 6 years ago

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Food Police Shut Down Raw Dairy Club

By Dr. Mercola

William Winter, a veterinarian, livestock nutritionist, holistic herd health consultant and a chapter leader for the Weston A. Price Foundation (WAPF), is the latest to fall victim to the "food police," who raided his Minnesota-based private food club. Operating under the name of Uptown Locavore, residents subscribed to this buying club in order to secure a share of farm-fresh foods like raw milk and cheese and meat.

Minneapolis health inspectors, however, obtained a search warrant for the club and sealed all food-containing refrigerators and freezers, preventing Winter from dispensing the products. On his Facebook page, Winter — who has been targeted by health officials in the past — explained that the club's intention is to provide wholesome food to the people who want it — and it's fully legal.

"Nothing is for sale to the public … We are not a 'store.' This is fully legal in America. However, many of the ground-pounders and officials don't even know our own American, state, county and city laws. They can come down on us hard," he wrote.1 Health inspectors cited Winter for six violations related to selling unlicensed dairy products, meat, fish and other foods, in part because some of them lacked labelling.

The Minnesota Department of Agriculture also targeted Winter's natural food buying club in 2010, halting operations while it investigated the potential "food licensing" issues.2

Meanwhile, tainted foods from lettuce to chicken continue to sicken and kill Americans, yet get health agencies' golden seal of approval. This includes dairy produced at concentrated animal feeding operations (CAFOs) — the bulk of the dairy products consumed in the U.S. — which have been implicated in a number of outbreaks in recent years.

The War Against Raw Milk and Farm-Fresh Foods Continues

Winter's is only the latest raw dairy club to be targeted — and potentially shut down — by authorities. According to A Campaign for Real Milk, a project of WAPF, "In Ontario, farmers may be fined $250,000 and sentenced to three years in jail [for selling or distributing raw milk] … Challenges to these laws are now underway. And in spite of onerous penalties, Michael and Dorothea Schmidt of Glencolton Farm provide milk to cow-shareholders in Toronto."3

Schmidt has been battling with the Canadian government for decades in order to provide safe raw milk to area residents. He has been harassed with threats, surveillance, intimidation and raids, even though no one has ever gotten sick from drinking the raw milk products he provides. Since it is illegal to sell raw milk in Canada, those who wanted to enjoy Schmidt's raw milk products formed the Glencolton farm share, in which each owned a piece of a cow and could therefore legally enjoy its milk.

The government eradicated this loophole, however, so the shareholders moved to own the farm instead of just the cow, by transforming into the ARC co-op. The government still intervened, however, forcing the members to "operate with caution" out of fear that they might be raided while trying to pick up a gallon of milk. Although members have tried to set up meetings with government officials to outline their concerns and reach an agreeable conclusion, the government has not been interested.4

Why are governments so intent on targeting small operators of food clubs delivering farm-fresh foods to local residents? As long as farmers are prevented from selling to consumers directly, processors can and do price fix the market, ultimately leading to the intentional destruction of small, family dairy farms and consolidation of CAFO dairy farms using taxpayer-funded subsidies.5

Which Foods Are Most Likely to Make You Sick?

Every year in the U.S., 48 million people get sick from foodborne illnesses, 128,000 are hospitalized and 3,000 die.6 Recent foodborne outbreaks in 2018 include salmonella found in eggs produced by Rose Acre Farms, one of the largest egg producers in the U.S., and E. coli in romaine lettuce grown in the Yuma, Arizona, region.

In recent years, we've seen additional outbreaks involving CAFO beef, flour, strawberries, frozen vegetables, packaged salads, pistachios and scallops, yet raw dairy products continue to be the acting scapegoats when it comes to foodborne illness. In reality, many foodborne illnesses are actually caused by CAFO meats and eggs, shellfish and pasteurized CAFO dairy.7

Poultry CAFOS are among the worst offenders when it comes to foodborne illness. Case in point, in April 2017, the U.S. Centers for Disease Control and Prevention (CDC) released a preliminary report stating that 8,547 cases of the more than 24,000 foodborne infections reported in 2016 were caused by campylobacter, bacteria that can cause diarrhea, fever and abdominal cramps (compared to 8,172 caused by salmonella).8

The campylobacter problem on CAFO chicken is so bad that the U.K.'s Food Standards Agency (FDA) urged people to stop washing raw chicken in 2014, as doing so could increase your risk of coming into contact with campylobacter.9

Even the CDC warns against the practice, noting that raw chicken is often contaminated with campylobacter bacteria (and sometimes salmonella and clostridium perfringens bacteria), and states, "During washing, chicken juices can spread in the kitchen and contaminate other foods, utensils and countertops."10

Yet, there's no crackdown on poultry CAFOs, shutting them down and forcing them to clean up their acts. Also revealing, while campylobacter is the bacteria responsible for most cases of foodborne illness, leafy greens are actually the No. 1 source of food poisoning in the U.S, accounting for nearly half of all illnesses.11

Meanwhile, even in the absence of a complaint of contamination, farmers and consumers are often harassed over the buying and selling of raw milk. In contrast, Blue Bell Creamery — one of the largest ice cream makers in the U.S. whose ice cream sickened 10 people with listeria, three of whom died as a result, in 2015, was fined just $175,000 for the incident.12

Big Dairy Controlling Milk

Big Dairy works hard to keep milk prices tightly controlled, for their own benefit. It wasn't that long ago (2011) that a class-action lawsuit on behalf of consumers was filed against a number of dairy companies and trade groups, charging they killed more than half a million young cows in order to artificially inflate the price of milk — a classic price fixing scheme, and certainly not the first, nor likely the last.13

In 2013, the Dairy Farmers of America (DFA) also paid a nearly $159 million fine to settle a 2007 lawsuit alleging the DFA conspired with a number of companies to suppress milk prices by closing bottling plants and stifling competition. In 2010, Dean Foods also paid dairy farms in the northeast a $30 million settlement as part of an antitrust lawsuit.14

Meanwhile, in 2016, the industrial dairy industry dumped 43 million gallons of milk due to a massive milk glut. The glut was the result of a 2014 spike in milk prices, which encouraged many dairy farmers to add more milk cows to their farms. U.S. Department of Agriculture (USDA) data showed that dairy cows increased by 40,000 in 2016, with a 1.4 percent increase in production per cow. With too much milk and nowhere to sell it, prices tanked.

At the same time, as CAFOs became the norm for dairy farms (even in idyllic-seeming dairy states like Vermont), farmers were forced to grow their herds and increase milk production using artificial (drug and hormone-based) methods, among others (like feeding cows an unnatural amount of grain-based food, 24-hour confinement and increased number of milkings per day).

Now, with a global oversupply of milk and falling milk prices, small dairy farmers are finding it impossible to make ends meet. One Massachusetts farmer who owns a 75-cow dairy farm said he's only getting 75 percent of the price he needs to break even. Amidst financial crisis, dairy farmer suicides are on the rise and many are forced to diversify into other products, such as pumpkins, sweetcorn and even raw milk.15 But Big Dairy is a powerful lobbying force to Congress in attempts to stop the latter at any cost.

In reality, the Organic Consumers Association (OCA) notes, raw milk could offer a major and much-needed push to rural economies. In fact, if 100 farms in Wisconsin could provide raw milk to 50 local families, it would lead to more than $10 million in "increased wealth and well-being" for Wisconsin residents.16

OCA further noted, "A boost like that is exactly what rural economies need as U.S. dairy farmers continue going out of business at an unsustainable rate. In 1950, there were about 3.5 million farms with milking cows. By 2016, there were only 41,809. Between 2015 and 2016, 1725 dairy farms went under."17

Why so Many People Drink Raw Milk

youtube

Download Interview Transcript

In the video above, you can view my interview with Winter, where he speaks about the health benefits and safety of raw milk. When speaking about raw milk, we're referring to milk that comes from animals raised on pasture, in healthy natural environments. Milk from CAFOs, where disease runs rampant, could not be safely consumed raw!

In contrast, animals raised on pasture are healthier, which means they're not routinely fed antibiotics, and are allowed to live out their lives as cows should, grazing and feeling the sun on their backs. Cows produce more milk, faster, when they're fed grain in the barn, as opposed to grazing on grass on pasture, which is why, unfortunately, the CAFO model has flourished. There are problems with pasteurization as well, as noted by WAPF:18

"Pasteurization destroys enzymes, diminishes vitamin content, denatures fragile milk proteins, destroys vitamins C, B12 and B6, kills beneficial bacteria, promotes pathogens and is associated with allergies, increased tooth decay, colic in infants, growth problems in children, osteoporosis, arthritis, heart disease and cancer.

Calves fed pasteurized milk do poorly and many die before maturity. Raw milk sours naturally but pasteurized milk turns putrid; processors must remove slime and pus from pasteurized milk by a process of centrifugal clarification.

Inspection of dairy herds for disease is not required for pasteurized milk. Pasteurization was instituted in the 1920s to combat TB [tuberculosis], infant diarrhea, undulant fever and other diseases caused by poor animal nutrition and dirty production methods. But times have changed and modern stainless steel tanks, milking machines, refrigerated trucks and inspection methods make pasteurization absolutely unnecessary for public protection."

So if you want to drink milk, grass fed raw milk from a high-quality source is generally superior in nutrition and flavor. It will also help to decrease the likelihood of insulin spikes from the milk sugar, courtesy of the thick layer of cream on top. There's also no doubt that you should have the option of choosing what to eat and from what sources.

This is why the fight over raw milk stands as a symbol of the much larger fight for food freedom. Ultimately, choosing food that comes from small regenerative farms — not CAFOs — is crucial. If you're interested in raw milk, here are tips for finding high-quality raw milk sources:

Does the farmer and his entire family drink the milk themselves?

Does the farmer test his milk for pathogens, and can he prove that his product has a low pathogenic population?

Are the cows fed with natural grass on a pasture? If not, what are they feeding the cows?

How long has the farmer been in business producing raw milk?

What conditions are the cows raised in? Do they look healthy?

Is the farm accredited with sanitation standards? In a related note, does the farm have a history of sanitation problems?

Is the milk quickly chilled after collecting?

Are cows given antibiotics and growth hormones? (Remember, organic standards do not allow this practice.)

from HealthyLife via Jake Glover on Inoreader https://articles.mercola.com/sites/articles/archive/2018/05/29/food-police-shut-down-raw-dairy-club.aspx

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takenews-blog1 · 7 years ago

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Why the CDC, NIH, and FDA shutdown has us frightened

New Post has been published on https://takenews.net/why-the-cdc-nih-and-fda-shutdown-has-us-frightened/

Why the CDC, NIH, and FDA shutdown has us frightened

The US Congress and the White Home didn’t agree on a brand new funds by midnight on Friday, and now the US authorities is formally shut down.

All furloughed federal workers can’t do their jobs — and even use their work emails or cell telephones — and plenty of authorities packages and analysis labs are grinding to a halt. And tens of 1000’s of them work on the businesses liable for public well being.

Half of the Division of Well being and Human Companies’ 80,000-member employees are furloughed, together with folks on the Facilities for Illness Management and Prevention who monitor illness outbreaks like flu, researchers on the Nationwide Institutes of Well being in search of illness cures, and inspectors on the Meals and Drug Administration who oversee pharmaceutical and meals security.

However most alarming is the shutdown’s results on sufferers: Households who’ve lengthy awaited government-run scientific trials that had been slated to begin Monday gained’t be capable to enroll in them. Which means the shutdown will hold them from doubtlessly lifesaving procedures, and may very well be an element of their deaths.

Right here’s what we are able to anticipate for well being and science throughout a shutdown. It’s making us anxious.

Proper now, America is within the grips of one of many deadliest seasonal flu epidemics in current reminiscence. And the shutdown will sluggish operations on CDC’s seasonal influenza program.

As Buzzfeed reviews, hours earlier than the federal government shutdown Friday evening, the company launched a contingency plan that stated flu outbreak monitoring would proceed throughout a shutdown, however that flu reviews could also be revealed on a slower schedule. (This was considered one of a number of indicators of confusion on the company going into the shutdown.) Nonetheless, the CDC has a restricted capability to speak their findings, since their social media accounts are at present not posting updates.

CDC won’t be posting updates, monitoring or responding to feedback on this account throughout the federal government shutdown. We might be again as quickly as potential.

Throughout the 2013 shutdown, state labs continued to do the work of surveilling illness to detect outbreaks, however they weren’t in a position to name on CDC epidemiologists for assist coordinating these investigations — and any samples despatched to the company piled up. Again then, the CDC additionally wasn’t in a position to replace nationwide illness developments or illness clusters in actual time.

Tom Frieden, who was director of the company for eight years, from 2009 to 2017, stated the 2013 shutdown “was the one time I felt I couldn’t do my job of defending Individuals.”

He added: “It was the actually essentially the most anxiety-provoking time as a result of it was like being blindfolded and having one hand tied behind your again.”

The 2013 authorities shutdown was like a scene from a science fiction film – empty labs and places of work at CDC. Shutdowns aren’t secure. https://t.co/8XKlXfSEPo

Although the federal government says “actions associated to the protection of human life” are presupposed to proceed within the occasion of a shutdown, Frieden stated the best way shutdowns work is “very irrational.”

“As a result of whether or not individuals are allowed to maintain working or not doesn’t really depend upon how necessary their jobs are,” he stated. “It will depend on the place the sources of funding come from and whether or not sure authorized definitions are met.”

For instance, in 2013, CDC workers engaged on monitoring foodborne sickness had been furloughed — after which needed to be put again on the job due to a extreme salmonella outbreak, attributable to uncooked rooster merchandise. The outbreak sickened 278 folks and hospitalized 76 throughout 18 states.

In keeping with the federal government’s 2018 contingency plan for a authorities shutdown, 50 % of employees throughout Well being and Human Companies businesses might be furloughed. The retention charges at particular businesses fluctuate, however the plan suggests solely 37 % of the CDC’s 13,600 workers can be retained. On the two different key well being businesses within the division, the NIH and FDA, the numbers are 23 % and 58 %, respectively.

Within the 2013 shutdown, Frieden stated, his company didn’t know of any deaths that occurred on account of authorities public well being companies being shuttered — however he couldn’t be certain. “In apply it’s definitely potential,” he stated. “We didn’t have our programs absolutely up and operating to evaluate that.”

The NIH has hospital amenities to deal with sufferers, however it’s additionally one of many main fundamental biomedical analysis establishments within the US, NIH analysis discovers new medication and vaccines, and works to higher perceive the biology of sickness. And never simply at its campus in Bethesda — about 80 % of its funds goes to awarding analysis grants for establishments throughout america. (Similar goes for the Nationwide Science Basis, which additionally gained’t be capable to approve new analysis grants.)

In 2013, the NIH needed to flip down a whole bunch of sufferers (lots of whom had been youngsters) who may have doubtlessly benefited from experimental procedures.

The identical would occur this time round, Anthony Fauci, the pinnacle of the NIH’s infectious illness division, informed the Related Press on Thursday.

“We nonetheless handle them,” he stated of sufferers at present enrolled in NIH hospitals for remedy. However new sufferers can be turned away.

As The Dialog reported, “This is among the few locations the place the shutdown may end in fatalities. Many sufferers solely take part in medical research when standard drugs has failed. It’s potential that some would-be sufferers, who would have obtained doubtlessly lifesaving medical care, will die with out these lifesaving remedies.”

Not with the ability to enroll new sufferers might also harm ongoing research. Generally, sufferers die or drop out of scientific trials. With the shutdown, researchers wouldn’t be capable to enroll new sufferers in ongoing research, which may have an effect on the research’ energy.

Throughout the 2013 shutdown, 73 % of its employees couldn’t go to work. Which means analysis tasks had been placed on maintain on the Bethesda facility, and new grants couldn’t exit to outdoors scientists awaiting funding for the reason that NIH (and Nationwide Science Basis) must cease processing grants.

The NIH stored on important employees to make sure the protection of vital cell traces, and to maintain analysis animals (mice and primates) alive.

However some analysis can’t survive a pause. “You have got experiments which have been occurring for months if not years, after which rapidly you’ve bought to cease — you’ll be able to’t do this,” Fauci informed the AP. “You may’t push the pause button on an experiment whenever you inject an animal with a specific substance to see what the response is after which it’s a must to go house for every week.”

And even PubMed, the widely-used well being science database run out of NIH, will cease being up to date for so long as the shutdown lasts. Researchers from around the globe attempting to entry the system for his or her work gained’t get essentially the most up-to-date outcomes.

The shutdown additionally throws a wrench into worldwide and disciplinary science collaboration. Throughout a shutdown, authorities scientists can’t attend conferences.

The Meals and Drug Administration not solely regulates prescription drugs and displays their security after they get available on the market; it additionally regulates a lot of the meals provide. And one of many scariest features of the federal government shutdown is that the company would prone to must put its meals security inspections on pause.

Within the 2013 shutdown, in keeping with Meals Security Information, FDA meals security inspectors had been “requested to show of their authorities cell telephones and never even test their work e-mail till Congress passes a funds.”

This didn’t imply all meals security inspections in America stopped; personal corporations continued with their very own monitoring practices, and inspectors on the US Division of Agriculture, which oversees inspections of meat, poultry, and eggs, had been allowed to proceed working. However the federal oversight the FDA gives — of 80 % of the meals provide — was shuttered.

Throughout this 12 months’s shutdown, the FDA will function in a restricted capability. In keeping with a memo on the FDA’s web site, the company will proceed to observe and reply to food-borne illness outbreaks, handle product remembers, and “screening the meals and medical merchandise which can be imported to the U.S. to guard shoppers and sufferers from dangerous merchandise, and addressing different vital public well being points.”

The FDA can also be at present coping with a saline IV bag scarcity. These important medical units are briefly provide attributable to a double whammy: Hurricane Maria disrupted manufacturing of IV saline luggage in factories in Puerto Rico, and the continuing extreme flu season has elevated their demand. The FDA memo reviews it can nonetheless work on this problem through the shutdown.

In a superb story on the 2013 authorities shutdown’s influence on well being, STAT reported that FDA employees who labored on analysis that may inform public well being selections stopped, as did “the company’s efforts to maintain drug labelling info updated and correct.”

Along with packages and companies which can be halted, we are able to additionally anticipate a extra sluggish FDA in shutdown mode. Once more, the federal government’s 2018 contingency plan for a authorities shutdown would hold solely 58 % of the FDA’s 17,000 employees members on the job. So drug approvals would decelerate, for instance (however they wouldn’t essentially cease, as a result of they’re partly funded by the personal sector).

Total, the federal government shutdown isn’t an apocalypse. Nevertheless it means the federal government is much less in a position to perform vital analysis, deal with points like drug and machine shortages, and monitor and reply to illness outbreaks.

Do you might have tales about how the shutdown affecting your work/sufferers?

Attain Julia at [email protected], on KeyBase at jbelluz, or via PGP: F65A 5539 A081 B01E 1E8D 498D 6489 E570 AEAB E972

Attain Brian at [email protected], on KeyBase at bresnick, or via PGP: 229A C31B 8C89 63C6 BD03 A36C 5888 5415 AFD9 EFC9

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gordonwilliamsweb · 4 years ago

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Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls

Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according to a Food and Drug Administration inspection report.

This story also ran on The Daily Beast. It can be republished for free.

The McPherson, Kansas, facility, which FDA inspectors wrote is the nation’s largest manufacturer of sterile injectable controlled substances, has a long, troubled history. Nearly a decade’s worth of FDA inspection reports, recalls and reprimands reviewed by KHN show the facility as a repeat offender. FDA investigators have repeatedly noted in reports that the plant has failed to control quality and contamination or fully investigate after production failures.

The 1970s-era manufacturing site has had persistent mold concerns over the years and been the focus of at least four intense FDA inspections since Pfizer took over its operations in late 2015, when it acquired Hospira. At the end of the January 2020 inspection, FDA investigators appeared to be growing frustrated.

Pfizer’s plant managers told investigators they knew they had either bacteria or mold throughout the facility at various times of the year. In a Jan. 17, 2020, establishment inspection report obtained by KHN, one of three FDA experts who visited wrote that Pfizer said it addressed problems and added “more cleaning activities in response to mold” after a 2018 inspection and “yet, there are still unexplained discrepancies.”

After the January 2020 inspection report, Pfizer immediately developed and put in place a corrective action plan, company spokesperson Eamonn Nolan told KHN. Neither Pfizer nor the FDA responded to requests to provide a copy of the plan.

Nolan, in an email last week, said “significant investments have been made” in resources, equipment and the facility. He stated all improvements related to covid manufacturing would be completed before vaccine production begins. He declined to provide details on when production of the vaccine would begin, but said the site is currently operating in a state of good manufacturing, which means it has met a regulatory standard enforced by the FDA.

“We are confident in the McPherson site’s ability to manufacture high-quality COVID-19 vaccine,” he wrote.

Large clinical trials have found Pfizer’s vaccine to be safe and 95% effective against covid.

News that the plant will be a fill-and-finish site for the Pfizer-BioNTech covid vaccine means more watchful eyes focused on the facility. “That alone should be helpful,” said Barbara Unger, a former pharmaceutical industry executive who now does manufacturing audits for companies.

It is unclear whether FDA investigators have returned to check on production practices in McPherson or plan to visit before vaccine production begins. The FDA did not respond to specific questions. FDA spokesperson Abigail Capobianco wrote in an email that the public “can be assured that the agency used all available tools and information to assess compliance.”

Pfizer’s emergency use authorization letter for its mRNA vaccine includes safeguards, such as quarterly reports to the FDA and a quality analysis from the company for each manufactured drug lot at least 48 hours before it is distributed.

The plant’s manufacturing issues can be traced in FDA reports dated from 2011 to last year. Several former FDA staffers and industry experts said the ongoing challenges in McPherson highlight how agency officials must balance aggressively going after a company’s manufacturing practices with the need to keep the supply of medications flowing to patients.

“I do not envy the FDA choices,” Unger said, describing a balancing act. “Which has the more significant public health risk?”

The site produces a wide array of sterile, generic medications used in hospitals, and its troubles have played a role in some big health system shortages, specifically for injectable opioid analgesics, according to a 2018 FDA statement.

The FDA rejected Pfizer’s biosimilar version of Amgen’s anemia drug Epogen because of concerns about the fill/finish plant in 2017. The same year, John Young, who was a group president at Pfizer, told investors the company had submitted a “corrective and preventative action plan” for the facility.

That is the same language used after the January 2020 inspection, which said there were contamination concerns for the site but not in the medicines. And it was Young, now Pfizer’s chief business officer, who last month told Congress that Pfizer had added production lines at the McPherson site to help meet covid-19 vaccine demands.

The facility’s record of recalls and field alerts include vials of medication that contained glass and cardboard particles and, as one customer complained, a “small insect or speck of dust.”

A 2017 FDA warning letter — which is a strong rebuke for the agency — said the contaminants such as cardboard and glass found in vials posed a “severe risk of harm to patients” and indicated that the facility’s process for manufacturing sterile injectable products was “out of control.”

FDA records show that multiple batches of vancomycin hydrochloride, a drug injected into hospital patients who have an infection that penicillin won’t treat, were recalled in 2016 and 2017.

John Avellanet, an FDA compliance expert and principal at Cerulean Associates, reviewed the 2020 inspection reports. He said he fears the fixes have been little but “window dressing.”

“They may have solved it in one instance, like the cardboard particles. But for some reason, they were never able to solve the contamination,” Avellanet said. “Whatever they are doing for quality control testing doesn’t appear to be working, because if it was working they wouldn’t continue to have these contamination problems.”

Pfizer shut down McPherson’s manufacturing in December 2017 even though the FDA had visited two months earlier and improved the facility’s inspection rating. McPherson’s management suspended production and rejected batches of finished products after finding mold on equipment in a filling area, according to an FDA inspection report. The facility returned to production weeks later.

When the FDA came back to inspect in late summer 2018, it found that procedures to prevent microbiological contamination of drugs were lacking. It also noted a lack of employee training, employees not following procedures, obstructed surfaces and in-house testing that did not guarantee drugs met standards.

In 2019, when CEO Albert Bourla took the helm at Pfizer, he told analysts it would be another hard year for U.S. hospitals to get their hands on sterile injectables because of ongoing work at the McPherson plant.

Since then, the coronavirus pandemic has taken a toll on the FDA’s ability to inspect plants, according to a recent report from the U.S. Government Accountability Office. The agency halted non-urgent foreign and domestic inspections in March 2020 out of concerns for staff safety and has since resumed select visits to domestic plants.

John Fuson, a partner at the law firm Crowell & Moring and former associate chief counsel at the FDA, said the agency has sent surveys to manufacturers to help it prioritize inspections. While not speaking directly about the Pfizer plant, Fuson said the FDA lacks the resources to do all the inspections “we might like it to do.”

It is unclear what oversight Pfizer’s McPherson facility has had in the past year. In 2020, the pharmaceutical company Gilead Sciences signed a multiyear agreement with Pfizer to produce its covid treatment remdesivir in the Kansas plant. Gilead spokesperson Arran Attridge wrote in an email that Gilead “evaluates our manufacturing partners’ facilities” to make sure they follow regulations.

FDA inspectors visited the McPherson plant annually before the pandemic, according to public FDA records. The plant was given ratings of VAI, or voluntary action indicated, or OAI, official action indicated, depending on the inspection. John Godshalk, a former FDA investigator who worked on vaccines, said a VAI is one of the most common inspection ratings given. That means the FDA is “trusting the company to fix” the observations made during the inspections, he said.

The FDA assigned Pfizer’s McPherson facility a VAI rating in January 2020 — and company executives were so pleased they reported in their third-quarter financial filing that the agency had “upgraded” the plant.

Before January 2020, the McPherson plant appears to have been operating with the more severe OAI rating since its 2018 inspection, according to FDA reports. Former FDA investigator Godshalk said an OAI puts the company on notice. It’s “what you don’t want as a company,” he said.

Pfizer employs about 1,500 people at the McPherson plant, plus contractors. Kasi Morales, executive director of McPherson Industrial Development Co., said the facility is the largest employer in the industrial town about an hour north of Wichita, Kansas, and not far from Interstate 70, a major east-west thoroughfare across the country.

The 2020 inspection report that led to McPherson’s “upgraded” rating listed repeat observations that involved quality control procedures not being fully followed and “contamination” with mold and bacteria on surfaces because of humidity and cleaning practices.

No contamination was found in the medications themselves during the inspection, but investigators described seeing operators “leaning over and talking over sterilized items being unwrapped.”

Notably, the 2020 inspection report states early on that Pfizer had made “significant management changes” since the previous inspection in 2018. That latest inspection spanned three weeks from December 2019 to January 2020 and inspectors wrote “management was cooperative and no refusals were encountered.”

Christopher Smith, vice president of quality operations for Pfizer’s U.S. and European Union sterile injectables, was at the McPherson facility periodically during the visit. In the end, he “expressed discontent” with several of the 2020 observations made by investigators and “repeatedly sought clarifications.”

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stephenmccull · 4 years ago

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Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recalls