Woodcock: U.S. inspections are returning to normal — White House not pushing for smaller vaccine vials — FDA pledges rapid review of Pfizer-BioNTech BLA submission

By David Lim

With Lauren Morello, Emily Martin, Rachel Roubein and Ben Leonard

— FDA Acting Commissioner Janet Woodcock says U.S. inspections are returning to normal operations.

— The White House is not pushing manufacturers to shift to making smaller vials of Covid-19 vaccine.

— FDA formally grants priority review to the Pfizer-BioNTech Covid-19 vaccine, pledges a rapid decision on the application for full approval.

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STATES TO BIDEN: THINK SMALL — State officials and physicians hoping to lift the nation’s declining Covid-19 vaccination rate have often asked the White House for the same thing: smaller vaccine vials.

The three vaccines in use in the U.S. — from Pfizer, Moderna and Johnson & Johnson — contain between five and 15 doses per vial. Once the vials are opened, the Pfizer and J&J vaccines must be used within six hours, and Moderna’s within 12 hours.

The demand for smaller vials, holding just one or two doses, is a reflection of how quickly the nation’s inoculation campaign has shifted away from mass vaccination sites to chipping away at the holdouts, one by one, report Dan Goldberg and Sarah Owermohle. The thinking is that smaller vials would enable more primary care offices, pharmacies and mobile clinics to administer shots when they find a willing patient without worrying about wasting doses.

“This is something that should be done because it is more efficient,” said Maine health official Nirav Shah, who is also president of the Association of State and Territorial Health Officials.

But the White House has ruled out trying to shift to smaller vaccine vials, even as top administration officials run low on ideas for overcoming hesitancy . White House officials said they understand the potential appeal of smaller vials, but they and pharmacy experts said quickly making that shift would be virtually impossible and unlikely to make a major impact on vaccination rates. It would take years and cost billions of dollars more to change up production lines — an effort further complicated by a shortage of everything from glass to staff to production space.

PFIZER SHOT GETS PRIORITY FDA REVIEW — FDA has granted priority review to Pfizer and BioNTech's application for full approval of their Covid-19 vaccine for people 16 and older, the companies said Friday.

According to the companies, the rolling submission was completed in May, putting the goal date for an FDA decision under the agency's user fee law in January. That's the latest date by which regulators can act; a decision could come much sooner, Lauren Gardner reports.

The end is near: The Pfizer vaccine review “is among the highest priorities of the agency,” the FDA said in a statement Friday. The agency said it intends to finish its review “far in advance” of the PDUFA goal date.

"This is another step forward in our ongoing efforts to provide protection against this awful virus," Pfizer Chair and CEO Albert Bourla tweeted Friday.

MOST VULNERABLE LEAST WORRIED ABOUT DELTA — Unvaccinated and partially vaccinated Americans, the groups most vulnerable to Covid, are the least concerned about the more contagious Delta variant, according to a CBS News poll.

While 48 percent of "not fully/not vaccinated" respondents in the poll released Sunday said they were concerned about the Delta variant, 72 percent of fully vaccinated Americans are worried, Myah Ward reports.

The Delta variant has caused rising caseloads in all 50 states, predominantly among unvaccinated populations. Nearly all recent Covid deaths in the U.S. have been among those not vaccinated.

GAO TO HHS, CDC: IMPROVE COVID-19 RESPONSE — The nonpartisan Government Accountability Office issued 15 recommendations to federal agencies Monday, which included calls for the CDC to bolster its testing capacity and HHS to be clearer about how it plans to spend hundreds of billions in unspent Covid relief funds.

The GAO recommended the CDC boost surge testing capacity and take stock of what the agency needs for making and distributing tests during public health emergencies, including looking at signing contracts before an emergency.

“The COVID-19 pandemic has shown that improving the federal process for developing infectious disease testing and increasing laboratory capacity should be a top priority,” said Comptroller General and GAO head Gene Dodaro in a release.

GAO’s report also recommended that HHS provide time frames for when it will spend Covid-19 relief funds to Congress. HHS has only obligated 78 percent of $324 billion in the Covid-19 relief laws before the American Rescue Plan and less than half of the $160 billion in American Rescue Plan funding, according to GAO. HHS has only spent 2 percent of the Rescue Plan funding and 52 percent of funding from the five initial relief laws.

WOODCOCK: U.S. INSPECTIONS RETURNING TO ‘STANDARD OPERATIONS’ — FDA Acting Commissioner Janet Woodcock said Monday that while the agency is still grappling with the pandemic’s impact on its inspectional work, progress is being made toward a return to normal. Early in the pandemic, the FDA paused most domestic and international inspections.

“I'm pleased to say that as of this month, we've begun transitioning back to standard operations for domestic inspections, while continuing to prioritize mission critical work for foreign inspections,” Woodcock said at the Regulatory Education for Industry’s annual conference.

FDA CONTEMPLATING VACCINE EUA TRANSITION STRATEGY, MARKS SAYS — The FDA is working on how it plans to approach a future where the emergency use authorization pathway for vaccines is no longer needed — but no plans have been finalized yet, according to vaccine regulator Peter Marks.

“At some point, there will be some relatively complicated-looking transition period for the vaccines and that will probably be because we will have various vaccines that will be transitioning to biologics license applications,” Marks said. “But it's possible that there may be indications, for instance, in pediatrics, that might be still in the emergency use category.”

The goal: Marks wants to avoid creating confusion or causing a reduction in trust in Covid-19 vaccines. "It's not having a vaccine that ends a pandemic, it's people getting vaccinated,” Marks said.

SHUREN WANTS MORE REGULATORY FLEXIBILITY OUTSIDE PANDEMIC — FDA chief medical device regulator Jeff Shuren argued Monday that the FDA should have greater regulatory flexibility and financial resources for interactive reviews even outside of public health emergencies like the Covid-19 pandemic.

The CDRH head argued that the U.S. should not change its safety and effectiveness standards for medical devices but said the agency should “have greater flexibility on how that standard could be met.” He also plugged an FDA proposal for the next reauthorization of medical device user fees to boost the agency’s resources to engage with sponsors in real time during reviews.

“Unfortunately, we are not resourced to do that routinely outside of the public health emergency,” Shuren said. “In fact, even during the public health emergency, we put the resources to do it, but at great expense for our ability to review non-Covid technologies.”

ALZHEIMER’S ASSOCIATION ‘EXTREMELY CONCERNED’ ABOUT ADUHELM ACCESS — Alzheimer’s Association executives told POLITICO Friday they are concerned by reports of several major medical systems and private payers deciding to not offer or cover Biogen’s controversial Alzheimer’s Disease drug Aduhelm due to its evidentiary profile.

“We were very disappointed — and surprised — to see the hesitancy by these groups to provide access,” said Kristen Clifford, the group’s chief program officer. The group, which has vocally advocated for Biogen’s drug, says it is conducting ongoing outreach to health systems and insurers.

“We will continue to outreach and especially to address concerns that we have around the payers questioning the clinical evidence and the science,” Clifford said.

BIDEN ADMIN KEEPS TRUMP’S CUTS TO DRUG DISCOUNT PROGRAM — Biden’s CMS is proposing to continue a nearly 30 percent cut in reimbursement for drugs purchased through the 340B discount program, POLITICO’s Rachel Roubein reports. Hospitals have fiercely opposed the policy, and sued to strike it. But a D.C. Circuit Court of Appeals upheld the cuts last summer, and the Supreme Court earlier this month said it would take up the case during its next term.

HEALTH OFFICIALS IN CALIFORNIA FACE MASKING DILEMMA — Seven Bay Area counties in California became the latest local health jurisdictions in the state to urge vaccinated residents to wear masks in indoor public settings amid a debate on whether to underscore the effectiveness of vaccines by allowing vaccinated residents to go maskless or be more cautious while the Delta variant spreads, POLITICO’s Victoria Colliver reports.

“We’re very reluctant to issue an order that requires them," said Marin County’s public health director. "I think we all worked hard as a community to reach case rates that offers the freedoms that come along with that.”

U.K. BETS ON FLU AND BOOSTER VACCINE CAMPAIGN FOR NHS — The recently announced NHS seasonal flu vaccination campaign, the largest in U.K. history, will coincide with plans to offer a third vaccine dose to those most vulnerable to Covid-19, POLITICO EU’s Asleigh Furlong reports.

The announcement comes two days after a report by the Academy of Medical Sciences that warned flu outbreaks could be twice as worse as usual and possibly overlap with a peak in Covid-19 infections.

Sunscreen battle: Environment vs. Availability — Industry and advocacy groups last week weighed in on the FDA’s proposal to conduct an environmental impact assessment for two sunscreen ingredients linked to damage to aquatic ecosystems. Two opposing viewpoints have emerged in response to the FDA’s proposal: One supportive and the other opposed. Environmental groups (and the National Park Service) point to a “weight of evidence” showing that several sunscreen ingredients are toxic to coral reefs and marine life and ask that the ingredients not be sold to consumers. Meanwhile, industry groups say the FDA’s actions could reduce the use of sunscreen and increase rates of skin cancer, and allege the FDA is overstepping its authority, indicating a legal challenge could be forthcoming.

FDA keeps diagnostics flexibility as Covid rebounds — At a Town Hall meeting last week , the FDA’s top diagnostics regulators said they will continue a policy meant to make it easier for companies to evaluate their diagnostic tests using non-U.S. data. The policy followed reports that developers were finding it difficult to collect samples from persons infected with Covid-19 in the U.S. due to declining case rates and increased vaccination rates. These samples are typically used to validate the accuracy of diagnostic tests. Timothy Stenzel, the FDA’s chief diagnostics regulator, said that despite a resurgence of Covid cases in some parts of the U.S., the FDA will still permit the use of foreign data as part of a broader development strategy employing limited U.S. data. “Of course, we have always said that we’d really like to see that you try to conduct those studies in the U.S. [first],” Stenzel said.

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FDA published draft guidance that provides product-specific recommendations on the design of bioequivalence studies to support abbreviated new drug applications for cilastatin sodium, imipenem and relebactam for injection.

CMS issued on Monday a proposed rule that floats a Jan. 1, 2022, start date for the five-year Radiation Oncology Model. The agency proposed removing liver cancer and brachytherapy from the model, adding an “extreme and uncontrollable circumstances policy,” and changing the baseline period from 2016–2018 to 2017–2019.

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