CDC director panel backs Pfizer boosters health workers, bucking advisers

By David Lim and Lauren Gardner

Presented by the Pharmaceutical Care Management Association (PCMA)

With help from Katherine Ellen Foley, Sarah Owermohle and Lauren Morello

— CDC Director Rochelle Walensky backed Pfizer boosters for at-risk workers, overruling her agency's vaccine advisory panel.

— The vaping industry is scrambling after the FDA continues to order e-cigarette products off the market.

— FDA laid out its latest proposal in negotiations with the medical device industry over the medical device user fee program, but the industry and agency remain far apart.

It’s FRIDAY. Welcome back to Prescription Pulse. What a year this last week has been (and when can we stop feeling this way?)!

Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from the Pharmaceutical Care Management Association (PCMA):

Congress is considering repealing the Medicare prescription drug rebate rule. If not repealed, the rule will increase Medicare Part D premiums 25% and cost taxpayers $170 billion. The federal government should repeal this rule and instead focus on policies that would reduce prescription drug costs.

CDC CHIEF BACKS BOOSTERS FOR ELDERLY, AT-RISK — CDC Director Rochelle Walensky endorsed the use of Pfizer and BioNTech's Covid-19 booster shot for workers at high risk of severe Covid-19, taking the rare step of overruling her agency's own advisers.

The decision arrived just before 1 a.m. on Friday, hours after the CDC’s external vaccine advisory panel overwhelmingly backed the additional dose for Americans 65 and older or who live in long-term care facilities. While that decision came easily, the committee deliberated for hours over whether to sanction the shots for any adult with underlying health conditions or whose job puts them at heightened risk of exposure to Covid. In the end, members voted 9-6 against endorsing boosters for the latter category after opponents argued there wasn’t enough data to suggest younger workers are at high risk of severe disease.

The rejection came after CDC officials indicated the “occupational or institutional setting” umbrella could apply to a wide array of people with nebulous definitions — think “essential workers,” unpaid caregivers of frail or immunocompromised people, and anyone who works in close physical proximity to others. “We might as well say, 'Just give it to anyone 18 and older,'" said committee member Pablo Sanchez of Ohio State University's Nationwide Children’s Hospital.

Walensky weighs in: The CDC chief nodded to that ongoing controversy, and her unusual decision to contradict CDC's vaccine advisory panel, in a statement on Friday. "It is my job to recognize where our actions can have the greatest impact," she said. "In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good."

Walensky also noted that her action aligned the CDC's recommendations for booster use with the FDA authorization, and added that the agency "will address, with the same sense of urgency," the use of Covid-19 boosters made by Moderna and Johnson & Johnson.

Aye, there’s the rub: But, much like the current authorization of third doses of Pfizer or Moderna for moderately to severely immunocompromised people, those seeking boosters merely have to attest to their qualifying condition. With no doctor’s notes or other documentation required, the dam may be broken for millions more Americans to get boosters. About 2.37 million people have received additional doses as of Thursday, according to CDC data.

Trust the process: The CDC committee’s two-day meeting kicked off Wednesday without a formal FDA decision to adjudicate. The agency issued its regulatory action that night , setting the stage for Thursday’s showdown. The amendment to Pfizer’s emergency use authorization permits a booster dose for people at high risk of severe disease or who are 65 and older, at least six months after completion of the primary two-dose series. The allowance doesn’t provide for Moderna or Johnson & Johnson recipients to get a Pfizer booster, since federal scientists are still crunching data on the safety and effectiveness of mixing brands.

ICYMI, here’s a rundown of the five biggest issues the panel identified on Wednesday ahead of the vote.

Reminder to pregnant people: While the advisory committee waited for the FDA to act on Wednesday, panel members heard more evidence about the safety and effectiveness of Covid vaccines in pregnant individuals, who have appeared in hospital ICUs at rates not seen since the beginning of the pandemic. Data collected to date on thousands of pregnant people show that vaccines appear safe for both the parent and the unborn child.

Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW.

CHAOS IN THE VAPING INDUSTRY ENSUES AFTER FDA’S FLAVOR BANS — As of Thursday, FDA issued 323 marketing denial orders covering about 1.17 million flavored e-cigarette products. Combined with applications the agency deemed incomplete, FDA removed over 6 million products from the market — although notably absent are those from big name brands like Juul, Vuse and NJOY.

Small and medium vape manufactures — many of which are retailers — are at a crossroads, Katherine reports: If they remove their flavored products from their inventory, they’ll likely go bankrupt; one company estimated that menthol- and tobacco-flavored products, which haven’t been ruled out yet, make up less than 1 percent of its total sales. But if they continue to sell banned flavors, the manufacturers risk legal and financial penalties from FDA.

Companies are divided. Some are choosing to continue selling their products, albeit covertly, either coded as things like “$20 stickers” online, or behind the counter and out of sight unless a customer knows to ask for them. “I don't think I'm doing anything wrong from an ethical or moral standpoint,” said one shop owner who had been ordered to take his products off the market.

Other shops are toying with towing the line of legality by switching out tobacco-derived nicotine with synthetic nicotine, which technically isn’t covered by the Center for Tobacco Products. And others are complying with their marketing denial orders, but considering legal options. “We're very committed to following the law,” said Amanda Wheeler, the president of the American Vapor Manufacturers Association. But, she added that “there was a definite moving of goal posts that has happened through FDA throughout the course of the PMTA process.”

The first e-cigarette manufacturer has already challenged FDA’s decision: On Wednesday, Turning Point Brands, a Kentucky-based company, asked the 6th U.S. Circuit Court of Appeals to overturn or modify the FDA’s marketing denial orders, saying they were “arbitrary and capricious,” Katherine reports.

Should TPB come out on top, it could set a precedent for other e-cigarette manufacturers that have been denied marketing orders. But, the court would have to find that FDA ignored relevant information that would have inevitably led to a different outcome, said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy.

Meanwhile, lawmakers are getting antsy for more FDA decisions: Today, Sens. Tim Kaine (D-Va.) and Mitt Romney (R-Utah) of the Senate Health, Education, Labor and Pensions Committee sent a letter to acting FDA commissioner Janet Woodcock asking her to set a definitive timeline for the agency’s decisions on applications from large manufacturers like Juul and menthol-flavored products. They also asked how the agency will enforce the sale of only products that have received marketing orders. The senators requested a staff briefing and answers to their questions by Oct. 1.

Overheard at the Global Tobacco & Nicotine Forum in London: On Wednesday, Todd Cecil, the Center for Tobacco Products deputy director for regulatory management, told conference attendees that FDA is still evaluating 100,000 to 200,000 products and is not making categorical decisions on flavors. He also said that the FDA is hoping to move “some” large brands’ PMTAs forward “in the short term” — but didn’t specify when.

BOURLA RALLIES PFIZER AGAINST DRUG PLAN AS DEMS SPLINTER — Pfizer's CEO sent a video message to employees Tuesday urging them to fight proposed government drug price negotiations, arguing that the provision would have “little positive impact” and expressing frustration with Congress.

In a three-minute video obtained by POLITICO, he framed the fight against Democrats’ pricing proposal — a version of H.R. 3 (117) in the reconciliation package — as “equally important” for employees as the company’s exceptional year developing and mass-manufacturing a Covid-19 vaccine. He added that the company would share methods to raise awareness on the issue in the next few days.

His remarks leaked hours after President Joe Biden praised Bourla by name in the kickoff to his global vaccine summit, where he hailed the Pfizer chief as a “good friend” and leader in the coronavirus fight.

But they also land among increasing dissent in the Democratic party over Speaker Nancy Pelosi ’s proposed drug pricing reform. Four House Democrats — who have received significant campaign donations from the pharmaceutical industry — oppose the plan, while moderate Sen. Kyrsten Sinema has voiced her concerns about it to Biden.

The president on Wednesday met with groups of congressional Democrats to salvage the $3.5 trillion reconciliation package.

A message from the Pharmaceutical Care Management Association (PCMA):

FDA OFFERS MDUFA V COUNTERPROPOSAL — The FDA on Wednesday outlined its counterproposal to the medical device industry in the latest round of negotiations over the fifth iteration of the Medical Device User Fee Amendments. The agency’s proposal , obtained by POLITICO, outlines two scenarios which both propose adding hundreds of full-time employees using new user fees collected from industry.

A source close to negotiations said the device industry is unlikely to support the plan, which both propose spending millions on a total product life cycle advisory program pilot.

“FDA wants all of industry to commit significant new resources to a program of uncertain benefit, that the uncertain benefit of which would only accrue to a very, very small subset of products and missions,” the source said.

But CDRH Director Jeff Shuren has publicly advocated for the idea, which he argues would accrue benefit to manufacturers through greater engagement and the public through resources for postmarket safety efforts. An FDA spokesperson said the agency is working to send the package to Congress by the January 15 statutory deadline — a goal AdvaMed CEO Scott Whitaker told reporters Thursday he shared.

“Yesterday, FDA presented our proposal for a total package of resources to support the operational success of the medical device user fee program, apply lessons learned during the COVID pandemic on a broader basis, ensure FDA experts remain at the leading edge of science, and further enhance patient safety,” the spokesperson said. “We look forward to continuing to negotiate these proposals with the industry.”

ADVAMED ANSWERS BARRAGE OF POLICY QUESTIONS — The largest medical device lobby on Thursday held a press conference with policy reporters that touched on a variety of industry issues and priorities, including concern about the supply of semiconductors used in medical devices, ethylene oxide regulations, and the Biden administration’s proposal to pull back a Trump-era policy offering four years of automatic Medicare coverage for breakthrough devices.

Whitaker pushed back against the Biden CMS decision to pull back the MCIT rule, arguing it is “not their remit” to decide if medical devices are safe and effective for Medicare patients.

“The CMS process is around reasonable and necessary, which is more of a budgetary determination than it is a safety and efficacy determination,” Whitaker said. “I don't think there are folks at CMS who have better expertise than folks at FDA about whether a product is safe or effective.”

On semiconductors, the trade lobby executive said that the global shortage is not “affecting us in a critical way today, but we’re starting to see signs that it could affect us in a critical way soon if the supply constraints continue.”

On ethylene oxide regulations, Whitaker said the device industry is having conversations with the EPA that will likely continue over the fall and possibly into 2022. The Biden administration “doesn’t feel like it’s more or less hostile” than the Trump administration’s regulatory efforts, he added.

ECRI, FDA PUBLISH DEVICE MATERIAL SAFETY DATA ANALYSES — As part of an effort to better understand the safety profile of materials used in implanted medical devices, FDA and ECRI on Wednesday released reports on magnesium, polypropylene, polyurethanes and siloxanes.

“One of the many ways that the FDA can help to stimulate innovation in products is to use its unique position to help innovators make better choices early in product development, which results in improved safety and effectiveness of medical devices,” Ed Margerrison, director of the FDA’s Office of Science and Engineering Laboratories, said in a statement.

FDA LAUNCHES AI/ML DEVICE LIST — FDA on Wednesday published a database of market-authorized medical devices that use artificial intelligence and machine learning, which includes information on device names, sponsor, product code and submission number.

“Although not a comprehensive list, the information provided by the FDA seeks to increase transparency about these devices and the FDA’s work in artificial intelligence and machine learning-enabled devices,” a CDRH email states.

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KHAN: FTC FOCUS IS ON ‘GATEKEEPERS,’ UNFAIR CONTRACTS — The Federal Trade Commission will focus on investigating “gatekeepers” who raise fees and impose unfair contract terms, in addition to combating a rising number of illegal mergers, Chair Lina Khan said in a memo Thursday outlining her priorities. POLITICO’s Leah Nylen reports Holly Vedova and Sam Levine — two staffers who have helmed the FTC’s competition and consumer protection bureaus, respectively, on a temporary basis since June — will also take on those posts permanently.

BROAD BENEFITS FROM AT-HOME HIV TESTS — A CDC program offering free, rapid self-tests for HIV attracted large numbers of men in high-risk groups who had never before taken an HIV test or had gone more than a year without being tested. Eighty-six percent of participants in the program reported recent HIV risk, the agency said in a study published Thursday in its Morbidity and Mortality Weekly Report. The testing program, called TakeMeHome, ran in 17 jurisdictions between March 2020 and March 2021.

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

FDA’s quiet action on clinical trial diversity — The FDA has begun using post-approval requirements to address concerns that the clinical trials used to support the approval of certain drugs were not sufficiently diverse with respect to ethnic or racial diversity, according to a review by AgencyIQ . The requirements have applied to at least four drugs in the last two years, including one granted supplemental approval this month. The FDA often requires companies to conduct post-approval studies to answer ongoing questions about the safety or efficacy of a drug. In four cases, however, FDA has now made clear that companies “should include sufficient representation of racial and ethnic minorities to better reflect the U.S. patient population and allow for interpretation of the results in these patient populations.”

FDA ‘surge’ to review Covid-19 antigen tests — The FDA’s Office of In Vitro Diagnostics and Radiological Health, which reviews tests for Covid-19, is ramping up staffing to prioritize the review of antigen tests — tests that detect the presence of a viral infection by detecting a specific viral antigen. The FDA has authorized 34 antigen tests so far for Covid-19, of which 10 are indicated for at-home use. After calling on the testing industry to develop and submit more rapid antigen tests for authorization, it appears that there are now so many submissions that there is a backlog at the agency, said OIVD Director Timothy Stenzel. “We have added more personnel from other EUA review areas onto the antigen review team, and we are making a concerted effort to reduce … turnaround time” for these submissions, Stenzel said at a Town Hall meeting this week. “We plan to get through all the current submissions as rapidly as possible. I hope this becomes evident in the days and weeks ahead,” he added.

Aduhelm, a drug that was supposed to be a blockbuster Alzheimer’s treatment for Biogen, has been a bust so far, STAT’s Adam Feuerstein and Damian Garde report. STAT estimates that just over 100 patients have received the costly infusion — leading Biogen to consider cost-cutting measures, including layoffs.

On Friday, FDA revoked three emergency use authorizations for three Covid-19 detection tests after companies informed the agency they were no longer in use, or requested them to be revoked.

On Friday, CMS announced a virtual Town Hall meeting for Dec. 14 and Dec. 15 to discuss fiscal year 2023 add-on payments for new medical services and technologies.

A message from the Pharmaceutical Care Management Association (PCMA):

Congress has shown bipartisan support to delay the Medicare prescription drug rebate rule and avoid increasing Medicare premiums by 25%. Now Congress should permanently repeal this rule to avoid disrupting Medicare beneficiaries’ affordable Part D prescription drug coverage and to save taxpayers $170 billion.

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