Programming note: We won’t be publishing Prescription Pulse from Monday, Aug. 29, to Monday, Sept. 5. We’ll be back in your inboxes on Wednesday, Sept. 7.
— The CDC’s vaccine advisers meet next week to deliberate on recommending Omicron-specific Covid-19 booster shots.
— FDA Commissioner Robert Califf wants the health care system to generate more clinical evidence.
— A new report from House Democrats on the Select Subcommittee on the Coronavirus Crisis reveals just how much the Trump Administration pressured the FDA over Covid product authorizations.
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CDC PANEL TO MEET ON OMICRON BOOSTERS — The CDC’s independent vaccine advisers will meet Thursday and Friday next week to discuss recommending updated Covid-19 boosters to cover the BA.4 and BA.5 Omicron strains that have dominated U.S. infections this summer. The meeting comes after Pfizer and, as of Wednesday, Moderna have applied to the FDA for emergency use authorization for their Omicron-specific products.
That puts the timeline for an FDA decision sometime next week. But the agency won’t convene its own independent advisory committee on vaccines, arguing that the panel’s June 28 discussion covered enough ground for regulators to make their own call.
“FDA has no new questions that warrant committee input,” Commissioner Robert Califf tweeted Thursday in an extensive thread about the agency’s posture as it reviews both companies’ applications. “When available, new boosters are expected to help provide greater protection against the currently circulating strains,” he added.
Outside angst: Some medical experts have urged regulators to hold off on green-lighting the shots until the manufacturers have human clinical data on their efficacy. Pfizer’s and Moderna’s applications are underpinned partly by early data on their boosters’ effects in mice since the FDA’s request that they focus on the BA.4 and BA.5 strains instead of the first Omicron variant didn’t come until the end of June.
Paul Offit, a Children’s Hospital of Philadelphia infectious disease expert on the FDA expert panel, told Lauren he was “unpleasantly surprised” that the committee won’t meet to publicly assess the data for what he considers a new product.
“If you hold this vaccine up as being some sort of magic bullet, then people are going to be disappointed” when they get mild illness, Offit said.
The administration’s take: Ashish Jha, the White House Covid-19 response coordinator, has bullishly promoted the prospect of the reformulated boosters, saying that “all the data suggests [they] should be highly effective against the new variants.”
“The big-picture bottom line is, these are substantial upgrades in our vaccines in terms of their ability to prevent infection, to prevent transmission, certainly to prevent serious illness and death,” Jha said of the bivalent boosters during a U.S. Chamber of Commerce event on Aug. 16.
Offit questioned the administration’s stance — urging a broad fall vaccination campaign to decrease the amount of circulating virus as opposed to tailoring recommendations to those most at risk for severe disease — given the mRNA vaccines’ track record of neutralizing antibodies tapering off after three to six months. “I think it is like a leaky sieve,” Offit said.
HHS HOLDING COMMERCIALIZATION TRANSITION PLANNING MEETING — The federal health department is convening pharmacies, providers, government agencies, consumer groups and industry on Aug. 30 for a virtual meeting to plan the potential transition of Covid-19 vaccines and therapies to the commercial marketplace. Leadership from the CDC, CMS, FDA, NIH, the Health Resources and Services Administration and the Administration for Strategic Preparedness and Response will attend the meeting.
Two breakout sessions will be held: One will focus on commercialization plans for Covid-19 vaccines, while the second will center on therapeutics. Discussion topics include reimbursement and coverage, regulatory issues, and how to make products available to under- and uninsured people, according to an event invite obtained by POLITICO.
“Given this process will take months and close coordination with stakeholders across the health care continuum, HHS is engaging closely with these stakeholders to plan and ensure that the transition happens smoothly when the time does come,” an HHS spokesperson said.
CALIFF: WE NEED TO GENERATE MORE EVIDENCE — Academics, health systems and professional societies should prioritize generating more clinical evidence to help the FDA more rapidly understand the risk-benefit profile of medical products, according to FDA Commissioner Robert Califf.
“When the FDA’s decisions generate controversy, it is often when the system fails to produce reliable evidence that clarifies an intervention’s risks and benefits during a relevant time frame,” Califf wrote in JAMA earlier this week. “The gap between FDA clearance or approval of a medical product (particularly when the accelerated approval pathway is used) and use of the product to treat patients should be filled by an invigorated clinical research system that generates evidence that patients, clinicians and health systems need to make well-informed decisions.”
CONGRESSIONAL REPORT SHOWS TRUMP WHITE HOUSE PRESSURED FDA ON COVID THERAPEUTICS — Democrats on the House Select Subcommittee on the Coronavirus Crisis published a report on Wednesday, detailing how senior Trump officials pressured the FDA around coronavirus authorizations, Katherine reports.
The findings of the report weren’t much of a surprise, but it offers new color through emails, texts and official testimony from former FDA Commissioner Stephen Hahn about how persistent some of those efforts inside the White House were throughout the summer and fall of 2020.
On hydroxychloroquine: After the FDA revoked authorization for hydroxychloroquine after data emerged showing its inefficacy and potential harm to Covid patients, Trump’s trade adviser Peter Navarro and coronavirus response volunteer Steven Hatfill pushed the FDA to reauthorize the drug. Hatfill characterized the disagreement between White House officials and the FDA as a forthcoming “knife fight.”
On Fauci: According to the report, Hatfill pushed for Anthony Fauci’s removal throughout the fall after the director of the National Institute of Allergy and Infectious Diseases dismissed the White House’s push for hydroxychloroquine. In September 2020, Hatfill told Navarro, “You really need to consider what is likely to happen over the next 2 months if this little idiot and his Covid treatment panel is not fired.”
On vaccines: Hahn testified to the subcommittee that the White House wasn’t happy with the FDA’s requirement that late-stage Covid-19 vaccine trials included a 60-day safety follow-up — which would delay their authorization until after the 2020 election.
And on Navarro’s emails: This report offers more evidence that Navarro used his personal email for presidential matters. The Department of Justice has sued Navarro to get him to turn over other such emails, first revealed by a separate report from the subcommittee, sent from his personal email account.
WASHINGTON AWAITS BIDEN OIRA NOMINEE — With the midterm elections approaching, close watchers of the regulatory apparatus are waiting for Biden to nominate someone to lead the small but powerful Office of Information and Regulatory Affairs, POLITICO’s Adam Cancryn reports.
The office, charged with reviewing regulations, could play an outsized role in the final two years of Biden’s term as the government implements major elements of Democrats’ just-passed climate, health and tax law.
“OIRA is always at the center of administrative activity — the joke is it’s the most powerful agency nobody’s ever heard of,” said Sharon Block, who served as its acting chief through Biden’s first year. “Now, it becomes even more important.”
The FDA on Tuesday published final guidance for tobacco manufacturers designing and conducting tobacco product perception and intention studies.
The FDA on Thursday published its annual report on the state of pharmaceutical quality.
The HHS Office of Inspector General posted a memo summarizing its findings that, in the first quarter of 2022, eight drug codes met CMS’ price-substitution criteria and had an average sales price that exceeded the average manufacturer price by 5 percent or more.
CMS on Thursday finalized its plan to indefinitely delay its radiation oncology payment model.