Moderna, Novavax hit major FDA milestones

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Feb 01, 2022 View in browser   By David Lim and Lauren Gardner With Katherine Ellen Foley  ON TAP — Two Covid-19 vaccines hit major milestones Monday. — The president's FDA nominee agreed to ethics-related concessions at a key Democratic senator's request, securing a crucial vote. — Congressional health leaders are pressing FDA and industry for an update on a user fee agreement for medical devices. It's Tuesday. Welcome back to Prescription Pulse. Your authors hope Wordle will remain free to play beyond "the time it moves to" The New York Times' games corner. Send tips (including for Wordle) and feedback 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). Coronavirus FDA GRANTS APPROVAL TO MODERNA COVID SHOT — Moderna's vaccine is now the second Covid-19 inoculation to be fully licensed for adult usage in the U.S., Lauren and Katherine report. The decision doesn't change much, practically speaking, though Moderna may now directly market the product, dubbed Spikevax, to consumers. However, it does give schools and workplaces that wish to mandate Covid vaccination another fully approved shot to point to in making their decisions. The big outstanding question involves where the company is on winning FDA emergency use authorization for the vaccine in adolescents. In October, Moderna announced it would delay seeking authorization for children ages 6 to 11 until regulators assess the shot's myocarditis risk in teens. A company spokesperson didn't respond to a request for comment on the status. AND NOVAVAX APPLIES FOR AUTHORIZATION — Novavax, the U.S.-based company that received the most federal funding of any vaccine manufacturer back in 2020, formally asked FDA to authorize its two-dose Covid vaccine on Monday, Lauren and Katherine report. Should FDA authorize Novavax's inoculation series, which appeared to be roughly 90 percent effective at preventing symptomatic Covid-19, it'd be the fourth available for adults in the U.S. In 2020, the U.S. purchased 100 million doses of the Novavax vaccine. Federal officials have hoped that Novavax could serve as a safe and effective option to ease vaccine supply. But the company has struggled with domestic manufacturing. If the vaccine is authorized, the Serum Institute of India would be responsible for producing it until other sites are ready. Meanwhile, Novavax is conducting ongoing studies on its vaccine as a booster and its safety and efficacy in kids 12 to 17. EYES EMOJI — Pfizer and BioNTech could submit a request as soon as Tuesday for emergency use authorization for its Covid vaccine for children under 5, The Washington Post reports. The submission reportedly would be for a two-shot regimen that might later include a third dose. In Congress CALIFF WINS OVER WARREN, PLEDGES ETHICAL CONCESSIONS — President Joe Biden's pick to lead FDA won a critical vote toward potential confirmation after pledging to not seek a job or compensation from drug or medical device companies he interacts with for four years after he leaves government, POLITICO's Laura Barrón-López and Adam Cancryn report. A spokesperson for Sen. Elizabeth Warren said that, should Califf's nomination ultimately come to a vote, the Massachusetts Democrat plans to support him. Califf also agreed to a four-year period in which he will recuse himself from decisions before the agency related to companies with which he had relationships. Originally, the recusal period was two years. Califf also garnered a forceful editorial board op-ed from The Wall Street Journal over the weekend calling for his confirmation, giving additional cover for GOP senators on the fence to vote for the Biden nominee. "Dr. Woodcock has shown heroic leadership during the pandemic as acting commissioner, but the agency needs a Senate-confirmed leader," the WSJ editorial board wrote Sunday. "Dr. Califf is well-qualified and deserves more White House political support." Other FDA-adjacent groups are also becoming more vocal. "In the current environment, it's hard to overstate the importance of Senate-confirmed leadership at the FDA. We implore the Senate to move with urgency and confirm a new FDA commissioner," the Alliance for a Stronger FDA said in a statement Monday morning. CONGRESS PRESSES FDA, INDUSTRY FOR DEVICE USER FEE AGREEMENT — Congressional health leaders on Friday called on FDA and the medical device industry to quickly wrap up negotiations over the next round of Medical Device User Fee Amendments. The agency and industry were supposed to finalize a MDUFA commitment letter and have HHS transmit it to Congress by Jan. 15. But that deadline was not met, and now lawmakers are getting antsy. Senate HELP leaders Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (R-N.C.), plus House Energy and Commerce Committee leaders Rep. Frank Pallone (D-N.J.) and Rep. Cathy McMorris Rodgers (R-Wash.), requested a Feb. 9 briefing with regulators and industry representatives "to update us on the progress made toward reaching an agreement and the expected timeline. "The FDA and medical device industry's significant delay in transmitting the MDUFA commitment letter jeopardizes our ability to thoroughly review the commitments under the letter," the lawmakers wrote. The House E&C health subcommittee convenes a hearing on the user fee agreements it already received from FDA and industry — PDUFA, GDUFA and BsUFA — Thursday at 10:30 a.m. EST. Eye on FDA FDA PUBLISHES ANNUAL CDRH REPORT — FDA on Monday released a 2021 year-in-review report outlining "programmatic accomplishments" of its medical device center. … AND ANNUAL DRUG SAFETY PRIORITIES — The agency also issued its 2021 drug safety priorities report Monday. Tobacco APPEALS COURT HEARS E-CIGARETTE CASE AGAINST FDA — Judges in the 5th Circuit Court of Appeals heard oral arguments Monday for a case brought by Triton Distribution, a Texas-based e-cigarette manufacturer, against FDA. Triton argues that FDA wrongly issued the company marketing denial orders for its vape products by changing the criteria it required for successful applications after the deadline. Judges will make a decision in the coming weeks or months. Should they side with Triton, its vape products will go back under review — but it could open the door for future appeals from other companies. In the Courts BCBS SETTLE SUIT AGAINST 'PHARMA BRO' — Blue Cross and Blue Shield of Minnesota announced a $28 million settlement Monday of a class action lawsuit against Vyera Pharmaceuticals, its parent company and two former executives — including Martin Shkreli. The proposed settlement would be paid out to a class of third-party payers who bought Daraprim, a drug to treat common parasitic infections and for which Vyera allegedly stifled generic competition to raise its price. FEDS, STATES REACH $13M SETTLEMENT WITH CARDINAL HEALTH — The U.S. government and several states settled a False Claims Act case against Cardinal Health on Monday, reaching a deal for the drug wholesaler to pay more than $13 million to resolve allegations that it paid kickbacks to physicians' practices. Pharma Moves Daniel Harder is now director for government affairs and public policy at Biogen. He most recently was director for U.S. government and public affairs at EMD Serono. Nancy Leaming and Brian Posner will retire this year from Biogen's board of directors. Julie Reed is now executive director of the Biosimilars Forum. She previously served as the forum's president for more than eight years and has served in executive roles at Pfizer, Hospira and Coherus BioSciences. Families USA has named Chantez Bailey its new director of communications. She previously was senior communications director for the National Resident Matching Program. Marisa Aleguas is now special assistant in the office of the assistant secretary for public affairs for the Department of Health and Human Services. She most recently was scheduler and executive assistant for Rep. Mike Levin (D-Calif.). Pharma in the States VA, WV GOVERNORS SEEK REPRIEVE FROM VAX MANDATE FOR HOSPITALS — The Republican governors of Virginia and West Virginia each requested a "limited waiver" Monday from the Centers for Medicare and Medicaid Services' interim rule requiring Covid-19 vaccinations among staff. They argue their states' rural and state-run hospital systems should get some relief while operating under crisis standards to avoid "a staffing breakdown." "This relief could take multiple forms, including broader conscience exemptions, flexibility on enforcement, or simply a six month delay of the rule," Glenn Youngkin and Jim Justice wrote. Quick Hits Former President Donald Trump's recent course correction on extolling the Covid-19 booster shot raises a key question for the GOP, POLITICO's Meridith McGraw writes: Is being anti-vaccine mandate enough for a Republican with national ambitions or does one have to be skeptical of the vaccine itself? San Francisco's public health department is allowing J&J Covid vaccine recipients to get a third dose, with the city advising a Pfizer-BioNTech shot, the San Francisco Chronicle reports. Inside AgencyIQ FDA drug division unveils updated "Guidance Agenda" — The FDA's Center for Drug Evaluation and Research (CDER), its division charged with the review of pharmaceuticals and some biologics, last week unveiled its latest " Guidance Agenda " — a list of guidance documents it plans to release in 2022. While the list of documents isn't binding, it does offer insights into the center's latest regulatory priorities. The latest list contains 98 guidance documents planned for release, of which 31 are new (the rest were previously announced). Some of the additions are especially noteworthy, including planned guidance documents on real-world evidence, drug quality (including related to the CARES Act of 2020), over-the-counter drug products, generic drug "data integrity" (referring to potential falsification of data), clinical trial "protocol deviations" (referring to unplanned changes made to a trial after it begins) and more. Document Drawer The CDC released the draft agenda for its Feb. 23–24 meeting of its Advisory Committee on Immunization Practices.   Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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