Departing FDA regulators argue current science doesn't support third Covid shot for most people

By Lauren Gardner and David Lim

Presented by Biogen

With help from Katherine Ellen Foley and Alice Miranda Ollstein.

— Departing FDA regulators signed onto a paper arguing the science isn’t solid enough to dole out Covid booster shots to the general population.

— FDA has denied 1,021,921 e-cigarette products, according to Mitch Zeller, director of FDA’s Center for Tobacco Products.

— The Biden administration wants to scrap a Trump-era policy that gives four years of Medicare coverage to breakthrough-designated medical devices that reach the market.

It’s Tuesday. Welcome back to Prescription Pulse. Well, this is some somber news.

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TO BOOST OR NOT TO BOOST? RETIRING FDA SCIENTISTS SAY ‘NOT YET’ — That is the question of the week as FDA’s external advisory panel on vaccines prepares to meet Friday to consider supporting Pfizer’s application to allow booster shots for Americans 16 and up. And it became even more contentious Monday, Lauren writes, when two retiring FDA vaccine specialists co-signed a paper with other U.S. and international scientists that concluded the existing science doesn’t support providing those extra doses to the general population just yet.

The paper, published in The Lancet , was co-led by Philip Krause and included Marion Gruber’s signature. The top two officials in FDA's Office of Vaccines Research and Review recently announced plans to retire, decisions a former agency official said were partly because of frustration with CDC’s booster-planning involvement.

The agency speaks out: Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, addressed the elephant in the virtual room during a Regulatory Affairs Professionals Society conference hours later. He expressed confidence that evidence to be presented during Friday’s meeting — including hotly anticipated data from Israel — will provide “a good rationale for why boosters might be necessary.” Krause and Gruber’s participation in the paper didn’t represent the U.S. government’s opinion, he said, noting they signed onto it in their capacity as “private citizens.”

As a federal employee, Marks said, “it is my obligation to ensure that the health of the United States population is well cared for and not to make global political decisions,” nodding to the paper’s argument that vaccines should be prioritized for countries where citizens have yet to receive their primary series.

One more thing: Marks hit back at those who have suggested FDA has been sidelined over political decisions favored by the Biden White House. “People have not pressured us to make certain decisions, OK?”

Count Colorado Gov. Jared Polis (D) among the critics of the retiring regulators: “We can all celebrate the news that Marion Gruber and Phil Klaus have left the FDA in disgrace over unnecessary delays for the booster,” Polis said at a press conference Monday. “They have blood on their hands, and there are thousands of Americans that are dead today because of their delays of the booster shot.”

TENSIONS RISE BETWEEN CDC, BIDEN ADVISERS OVER BOOSTERS — Senior Biden Covid-19 officials are clashing with CDC as the administration stares down its Sept. 20 deadline to begin doling out booster shots, our Erin Banco, Sarah Owermohle and Adam Cancryn report. One episode in particular — when an agency doctor advised a risk-based approach to boosters during the CDC advisory committee hearing last month — irked Biden health officials, since CDC Director Rochelle Walensky had publicly endorsed the administration’s plan days before.

CDC officials working on the pandemic response are also frustrated with what they view as unrealistic expectations from the White House, our colleagues report. “Science takes time,” one agency official said. “I don’t know how many times we have to say this.”

ICYMI: CDC studies released Friday suggested vaccine efficacy in preventing hospitalizations for those 75 and older declined over the summer as the Delta variant spread, Erin reports. Still, the shots continue to prevent severe disease for most Americans, even while they become less effective at precluding infection.

FDA: TRUST THE PROCESS ON COVID SHOTS FOR KIDS — Marks and Acting Commissioner Janet Woodcock entered the Covid-vaccines-for-children chat Friday, issuing a statement promising the agency is working as quickly as possible on the issue while cautioning that the science can’t be rushed. The lengthy statement came hours after President Joe Biden promised that the country’s “top doctors” would keep the public informed about the process.

Marks and Woodcock noted that pediatric trial participants will be monitored for "at least about two months" to ensure their safety, a line that immediately excited some social media advocates who have criticized regulators for what they see as slow-walking their decision. FDA has weighed requiring four to six months of data from the companies’ pediatric trials before making a regulatory call — something the American Academy of Pediatrics has said is unnecessary given long-standing evidence that vaccine side effects occur within two months of inoculation.

When asked to clarify what “at least about two months” means, an FDA spokesperson referred Lauren to the statement.

FDA MARKETING DENIAL ORDERS REACH MORE THAN 1 MILLION E-CIGARETTE PRODUCTS — As of the close of business on Friday, FDA had issued 186 marketing denial orders that cover 1,021,921 e-cigarette products, Mitch Zeller, the director of FDA’s Center for Tobacco Products, told POLITICO. Those denials, in addition to notices sent to companies with incomplete applications, account for 94 percent of the premarket tobacco applications submitted to the agency last September.

Most denials are for small- to medium-sized manufacturers, many of whom risk going out of business. The agency has stated it will make decisions on the remaining applications, including those from market-share goliaths like Juul, Vuse and NJOY, on a “rolling basis.”

A lose-lose for the FDA: No one is happy with FDA’s decisions. Rep. Raja Krishnamoorthi (D-Ill.), co-founder of the Congressional Caucus to End the Youth Vaping Epidemic, published a letter to Acting FDA Commissioner Janet Woodcock criticizing the agency for having ongoing reviews open, particularly for major players like Juul, whose products widely appeal to teens. He also asked for a staff briefing explaining why FDA missed its Sept. 9 deadline for evaluating applications and weekly staff briefings until the agency has gone through them all.

On the other side of the story are vaping advocacy groups, who insist the marketing denial orders FDA has issued so far will only hurt adults who use e-cigarettes to quit smoking. “We may be witnessing the slow-motion death of tobacco harm reduction,” said Gregory Conley, the president of the American Vaping Association, citing FDA’s marketing denial orders. Confounded with that worry are the proposed higher taxes on tobacco and other nicotine products Democrats put forward Monday , which Conley said will discourage smokers from switching to e-cigarettes.

JCT SAYS HOUSE DRUG PRICING LEGISLATION WOULD SAVE $700B — House Democrats moved this week to mark up a beefed-up version of the sweeping H.R.3 that allows negotiation over hundreds of drugs, penalizes companies that raise prices faster than inflation and applies both policies to private plans as well as Medicare, Alice Miranda Ollstein reports.

With pressure on Democrats to raise enough revenue to fund major expansions of Medicare, Medicaid and Obamacare, the bill will save an estimated $700 billion over 10 years, compared to the $492 billion saved by the previous version, according to the Joint Committee on Taxation.

On Monday, as the House Energy and Commerce Committee also began marking up the health care pieces of Democrats’ $3.5 trillion social spending package, moderate Democratic Reps. Scott Peters (D-Calif.) and Kurt Schrader (D-Ore.) brought up their own, far narrower alternative to Speaker Pelosi’s drug pricing bill. Their bill would allow negotiation for only a small subset of drugs in Medicare Part B that have no competition.

MEXICO’S U.S. SUPPLY CHAIN AMBITIONS TO INCLUDE PHARMACEUTICALS — A U.S.-Mexico supply chain working group will examine how the two countries can work together to develop pharmaceuticals and other medical supplies, Mexico’s Economy Minister Tatiana Clouthier told Doug Palmer. Specifically, Mexico wants to focus on producing the active ingredients in drugs and personal protective gear and components for medical devices.

FDA KICKS OFF COMPOUNDING CONFERENCE — The two-day virtual conference begins today and will include panel discussions “on inspections and regulatory oversight, health care provider perspectives on compounding quality and patient needs, and the future of the outsourcing facility sector,” per the agency.

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

BIDEN PICKS PRIVACY ADVOCATE FOR FTC — President Joe Biden nominated privacy advocate Alvaro Bedoya Monday for a seat on the Federal Trade Commission, an agency facing accusations of lax scrutiny of major tech platforms’ anti-competitive behavior and data practices, POLITICO’s Leah Nylen and Alexandra S. Levine report. Bedoya, a professor at Georgetown University’s law school, previously served as chief counsel to the Senate Judiciary Subcommittee, where he organized hearings on mobile location tracking and biometric privacy.

BIDEN ADMIN PROPOSES SCRAPPING TRUMP-ERA MCIT RULE — The Biden administration on Monday proposed rolling back a Trump-era policy that automatically granted four years of Medicare coverage to breakthrough-designated medical devices that win market authorization from FDA.

The administration argues the policy — known as the Medicare Coverage of Innovative Technology rule — doesn’t require adequate clinical evidence that breakthrough devices are necessary and reasonable for Medicare patients.

“We no longer agree that the FDA safety and effectiveness standards alone are sufficient to support open-ended Medicare coverage,” states the proposed rule signed by CMS Administrator Chiquita Brooks-LaSure and HHS Secretary Xavier Becerra. Health industry interests mounted a strong lobbying effort to retain the rule.

The federal government is collecting public comment on the policy change for 30 days instead of 60 days to finalize the change before Dec. 15, when the Trump rule was supposed to take effect.

“We are committed to exploring other policy options and statutory authorities for coverage that better suit the needs of Medicare beneficiaries and other stakeholders when the items or services are supported by adequate evidence,” CMS and HHS wrote.

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LABCORP COMPLETES ACQUISITION OF MYRIAD’S VECTRA BUSINESS — Myriad Genetics announced Monday it completed a $150 million sale of certain intellectual property, including its rheumatoid arthritis Vectra test to LabCorp.

The Association for Accessible Medicines has hired Polly Webster as vice president for federal affairs and Scott Kuzner as senior director for sciences and regulatory affairs. Webster most recently worked at Kaiser Permanente after holding health policy positions on Capitol Hill, and Kuzner was previously at the United States Pharmacopeial Convention.

BIDEN TO PRESS WORLD LEADERS ON VACCINATION EFFORT — Biden will push world leaders next week at a virtual summit to commit to immunizing the world against Covid-19, POLITICO’s Carmen Paun reports. He’ll urge attendees at the Sept. 22 U.S.-hosted event to vow to bolster vaccine supply and administration. The White House has caught flak from the World Health Organization and others over its push to provide booster shots to Americans before much of the world has gotten their primary vaccine series.

HHS published a notice today allowing licensed pharmacists, qualified pharmacy technicians and pharmacy interns to administer Covid-19 therapeutics authorized, approved or cleared by FDA under the Public Readiness and Emergency Preparedness Act. Pharmacists may also order these therapies in addition to administering them.

A message from Biogen:

Neurological diseases are the leading cause of disability and the second-leading cause of death worldwide. At Biogen, we believe that no other disease area holds as much need or as much promise for medical breakthroughs as neuroscience. Our research and development is driven by the potential to transform the lives of patients. Our focus on neuroscience, our deep scientific expertise, and our courage to take risks make us leaders in the research and development of medicines to transform neuroscience to benefit society. Biogen remains focused, investing in research to prevent or treat brain diseases once considered too difficult, too unpredictable, or too risky to tackle. Learn more about Biogen’s efforts in innovation and commitment to changing the lives of families impacted by neurological diseases.

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