FDA lays out vision for annual Covid vaccine updates

Presented by The Campaign for Sustainable Rx Pricing

With Megan R. Wilson

Driving the Day

FDA ADVISERS TO DISCUSS FUTURE COVID VACCINE UPDATES — The FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled to meet all day Thursday to discuss all things regarding future Covid-19 vaccines.

The official meeting agenda, which the agency made public yesterday, has only one vote scheduled. Advisers will vote on whether to recommend replacing the primary Covid-19 vaccine series with the updated bivalent boosters available from Pfizer-BioNTech and Moderna.

Annual boosters? The expert panel is slated to discuss a number of pressing matters related to future Covid boosters, including a potential yearly update to shots based on the most widely circulating variant.

The agency expects it would need to convene the vaccine advisory committee around June every year to discuss updating boosters that would be rolled out around September.

The FDA is asking the committee to discuss what information would be needed to update the boosters annually, including for this fall. The hope is that a routine immunization schedule, like the one for the flu, would lead to increased vaccine uptake.

“When you have recommendations that are changing, that can certainly lead to some confusion,” Neil Maniar, the director of the Master of Public Health Program at Northeastern University, told Prescription Pulse. “This is a really important opportunity … to kind of hit the reset button in a way, and to say ‘this is what it’s going to be like moving forward now for all of us.’”

New data drop: Biden administration officials are expected to release updated data this week on how bivalent vaccines fare against even newer variants, which will likely come up in the Thursday meeting.

“On Wednesday, we are expecting to release updated vaccine effectiveness data on how the bivalent boosters are protecting against XBB.1.5. The data we have seen are promising and reinforce how important vaccination is to protecting health,” CDC Director Rochelle Walensky in a Washington Post live chat on Monday.

Other topics of discussion: The group will also discuss whether enough data shows that healthy adults generate enough immunity from natural exposure to Covid-19 to merit only one shot a year. Adults with compromised immune systems or young children who aren’t likely to be exposed to the virus may continue to need two shots.

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. ChatGPT has been listed as a co-author on at least four scientific research papers — and we’re not so sure what to make of it. We’re all human here.

Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, Ruth Reader talks with Adam Cancryn about Jeff Zients, the White House’s former Covid czar who’s set to become President Joe Biden’s new chief of staff, and how the managerial prowess he showed in his first stint there will be put to the test.

Industry Intel

THE LOBBYING $$$ DISCLOSURES ARE IN — The pharmaceutical industry once again dominates the list of top health lobbying spenders, Megan reports.

Of the 76 health care organizations that spent $2 million or more in 2022 on lobbying, 32 are from the pharmaceutical industry, according to her tabulation of records that include newly disclosed fourth-quarter lobbying figures. Here’s a snapshot of the top 15 within the sector (which doesn’t include other big-money interests, such as insurance and hospitals):

— Pharmaceutical Research and Manufacturers of America (PhRMA): $28.3 million (vs. $29.6 million in 2021)
— Pfizer: $13.6 million (vs. $10.3 million)
— Biotechnology Innovation Organization (BIO): $13.3 million (vs. $13.3 million)
— CVS Health: 10.6 million (vs. $9.7 million)
— Amgen: $10.1 million (vs. $9.8 million)
— Genentech: $8.8 million (vs. $9.1 million)
— Pharmaceutical Care Management Association (PCMA): $8.7 million (vs. $7.8 million)
— Merck: $8.3 million (vs. $8 million)
— AbbVie: $8.2 million (vs. $7 million)
— Gilead Sciences: $8 million (vs. $8.2 million)
— Johnson & Johnson: $7.8 million (vs. $6.1 million)
— Eli Lilly & Co.: $6.8 million (vs. $7 million)
— Illumina: $6.1 million (vs. $3.3 million)
— Bayer: $6 million (vs. $4.7 million)
— Bristol Myers Squibb: $5.4 million (vs. $5.4 million)

Eye on the FDA

FDA OFFICIAL RECOMMENDS MAKENA WITHDRAWAL — The FDA official who presided over the agency’s October meeting when it advocated pulling a preterm birth drug from the market has issued a memo agreeing with the proposal.

In a document posted online Friday, Celia Witten, deputy director of the FDA’s Center for Biologics Evaluation and Research, summarized the meeting’s discussion and included her own recommendation that regulators withdraw its approval of Makena, marketed to help prevent preterm birth, more than a decade after it was green-lit for consumers on an accelerated basis.

Witten agreed with members of the agency’s obstetrics and reproductive drugs advisory committee that the drug hasn’t proven effective in either a broad or a narrower population proposed by maker Covis, and that known and suspected safety concerns are enough to tip the balance in favor of withdrawal.

“I do not think there is a favorable benefit-risk profile to support Makena’s remaining on the market and recommend approval be withdrawn,” she wrote. “There is equipoise for a new study, which I hope will be feasible to conduct.”

What’s next: Covis and the FDA’s drug office have until March 6 to respond to Witten’s report. Commissioner Robert Califf and the agency’s chief scientist will consider any submissions in making the final decision on the withdrawal proposal.

BIDEN URGES HHS, DHS TO ISSUE MEDICATION ABORTION GUIDANCE — President Joe Biden signed a memorandum over the weekend directing HHS and the Department of Homeland Security to consider new guidance “to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone” — a key drug used in medication abortion — “no matter where they live.”

The memo also encourages the agencies to consider actions “to educate individuals on their ability to seek legal reproductive care, free from threats or violence.”

It comes as states with abortion restrictions — particularly before 10 weeks of pregnancy, which is when mifepristone is indicated for — hit back at the FDA’s move earlier this month to allow corner-store pharmacies to dispense the drug for the first time.

FDA: ORPHAN DRUG APPROACH STAYING THE SAME — The FDA announced Monday it intends to continue to tie orphan-drug exclusivity to indications approved by the agency instead of an entire disease area.

The decision follows a ruling by the Court of Appeals for the Eleventh Circuit that the orphan-drug exclusivity for the FDA’s approval of Catalyst Pharmaceuticals’ drug in November 2018 for the treatment of Lambert-Eaton myasthenic syndrome, a rare autoimmune disease, in adults blocks the agency from approving other firms’ drugs for other LEMS indications.

In May 2019, the agency approved a drug from Jacobus for the treatment of LEMS in children — a decision that Catalyst sued over in June 2019. As a result of the circuit court ruling, the FDA set aside the approval of Jacobus’ LEMS drug.

The agency argues its interpretation of the orphan drug exclusivity law “best advances” the balance of incentivizing rare disease drug development and ensuring patients — especially children — have access to orphan drugs.

“FDA continues to believe that the statutory text does not unambiguously require that orphan-drug exclusivity extend to the entire disease or condition for which a drug received orphan-drug designation if the drug is only approved for some uses within that disease or condition,” Lauren Roth, FDA associate commissioner for policy, wrote in a notice published in the Federal Register on Monday.

Coronavirus

BIDEN TAPPING ZIENTS AS CHIEF OF STAFF — Jeff Zients, the former White House Covid response czar, is expected to be tapped by President Joe Biden as his next chief of staff. POLITICO’s Adam Cancryn explores what Zients’ time as the manager of the federal government’s response to the Covid-19 pandemic signifies about his return to the White House.

Pharma Moves

The Campaign for Tobacco-Free Kids has named John Bowman as its executive vice president for U.S. programs. Previously, Bowman was the managing director of government affairs for the Natural Resources Defense Council.

Quick Hits

POLITICO’s Meredith Lee Hill reports the Department of Justice is conducting a criminal investigation into Abbott over the way it handled the contamination of infant formula.

Document Drawer

The FDA published final guidance on Friday for compounding certain ibuprofen oral suspension products.

The FDA issued final guidance on Monday for clinical researchers developing drugs that contain cannabis or cannabis-derived compounds, POLITICO’s Natalie Fertig reports.

The FDA said on Monday that its Peripheral and Central Nervous System Drugs Advisory Committee would meet on March 22 to discuss Biogen’s new drug application for tofersen, which is intended to treat a rare form of amyotrophic lateral sclerosis.