| | | | |  | | By Lauren Gardner and David Lim | 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. ON TAP — Pfizer and BioNTech apply for EUA for their Covid-19 Omicron booster. — Anthony Fauci will retire from government service by the end of the year. — An abortion pill manufacturer ended its legal challenge in Mississippi but suggested it's not abandoning court fights. It's Tuesday. Welcome to Prescription Pulse. Despite Monday's busy news day, August is still pretty quiet. Why don't we meet up for coffee? Send proposed java venues, tips 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 ).
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Pfizer and BioNTech applied for FDA emergency use authorization of their Omicron-specific booster shot. | Emily Elconin/Getty Images | PFIZER PURSUES EUA FOR OMICRON BOOSTER — It wouldn't be back-to-school season without Covid-19 vaccine development (or so it seems for us here at Prescription Pulse). Pfizer and BioNTech filed their application on Monday for FDA emergency use authorization of their Omicron-specific booster shot, setting the stage for regulators to sign off on the reformulated vaccine by September. The rundown: As requested by the FDA, this vaccine recipe would target the original coronavirus strain and the BA.4 and BA.5 Omicron subvariants that have dominated U.S. infections this summer. The companies are pursuing authorization for the shot for people ages 12 and up, putting the new cocktail out of reach for younger children — though it's worth noting that vaccine uptake nationally for kids under 12 is middling at best. The timeline: The FDA and the CDC can convene their independent advisory committees to discuss Pfizer and BioNTech's data and give formal recommendations, though they're not required to do so. Something to keep in mind: The companies say their shot will be ready for distribution pronto in September, while Moderna's Omicron-focused offering seems to be further behind . There's been a lot of chatter among agency advisers about the time demands placed on members who have full-time jobs. The FDA didn't respond to an inquiry about whether an advisory committee meeting will be scheduled. NOVAVAX SHOT AUTHORIZED, RECOMMENDED FOR TEENS — Case in point: Late Friday, use of Novavax's Covid-19 vaccine in teens received emergency use authorization from the FDA, followed by a formal CDC recommendation on Monday — neither of which was preceded by an advisers' meeting. The two-dose regimen is now sanctioned for those 12 and older.
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Anthony Fauci will step down from his longtime role in public service at the end of this year. | Alex Wong/Getty Images | FAUCI TO LEAVE GOVERNMENT AT YEAR'S END — Anthony Fauci, arguably the most recognizable public health official in the United States, announced Monday he plans to depart public service in December . The closely held decision sets the stage for the National Institute of Allergy and Infectious Diseases director to pursue other work. However, Republicans, if they retake majorities in the midterm elections, say they plan to still call him to Capitol Hill to investigate the government's pandemic response, likely with a focus on Covid's origins. "Retirement can't shield Dr. Fauci from congressional oversight," said Rep. James Comer (R-Ky.), the ranking member on the House Oversight Committee, in a statement. But public health leaders say the time is right for the prolific infectious disease expert to step back from the limelight. The pandemic-era attention has taken a personal toll on Fauci, 81, who received multiple death threats, which led to a security detail being assigned to protect him. "I think when the history books look back at his tenure over time, history will clearly support his view of his work, not the view of his detractors," American Public Health Association executive director Georges Benjamin said. Fauci told POLITICO that his work with President George W. Bush to create the President's Emergency Plan for AIDS Relief, or PEPFAR, a global program the State Department estimates has saved 21 million lives, "may be the most impactful thing I have done in my career." Leana Wen, a public health professor at George Washington University and former Baltimore health commissioner, argued that Fauci's behind-the-scenes role in fighting Covid is "far more influential" than his public one. "We tend to think of Dr. Fauci as the public face of Covid policies, but actually his most significant achievements are in the scientific elements in leading the science behind the [Moderna] vaccines and treatment," she said.
| | | ABORTION PILL MAKER ENDS MISSISSIPPI CHALLENGE — On Thursday, GenBioPro, the manufacturer of one of two drugs used in medication abortion, withdrew its legal challenge to a Mississippi law effectively banning telehealth abortions. "Given the changed national landscape, we have decided to adjust our strategy and withdraw our existing case in Mississippi," generic mifepristone maker GenBioPro said Friday, adding that it would announce "next steps" soon. Mississippi falls under the U.S. appeals court's 5th Circuit, widely considered the most conservative in the country. The company could opt to challenge other state laws in more favorable judicial venues that, since Roe v. Wade was overturned, explicitly ban all abortions. ABORTION 'REVERSAL' MISINFO FINDS SOCIAL MEDIA HOME — Meanwhile, the post-Dobbs fallout continues, with posts about unproven "abortion reversal pills" skyrocketing since the decision came down, POLITICO's Rebecca Kern and Ruth Reader report. Claims about the pills have proliferated on social media for years but have found new life since late June. A POLITICO analysis of abortion-reversal content across major platforms showed engagement — think likes, reposts and comments — increased significantly after the Dobbs decision, with Facebook seeing a spike of 3,500 interactions with abortion reversal pill content on June 24 — the day of the ruling — up from 20 on June 23. The reversal regimen involves an individual taking progesterone after ingesting the first pill, mifepristone, in the two-pill medication abortion treatment. But the American College of Obstetricians and Gynecologists says the reversal treatment isn't backed by science and can cause dangerous hemorrhaging.
| | | PhRMA'S TOP DEM STEPS DOWN — Debra DeShong, the most senior Democrat at the Pharmaceutical Research and Manufacturers of America, is leaving the trade group, she announced on Friday. Her departure comes as the pharmaceutical industry works to regroup following a rare legislative defeat over the industry's stance on drug pricing policies, POLITICO's Megan R. Wilson writes. The association is simultaneously trying to restock its advocacy bench with well-connected Democrats. Mike Woody is rejoining PhRMA after a dozen years at another lobby shop, Megan reports.
| | | BAVARIAN NORDIC: 400K MONKEYPOX VACCINE DOSES STILL VIABLE — The Danish manufacturer of the monkeypox vaccine has determined that 400,000 expired doses slated for destruction are still viable, POLITICO's Helen Collis reports. The firm is testing some of the 28 million doses that expired approximately two years ago at the U.S.' request, CEO Paul Chaplin said. The company's finding comes as U.S. demand far outstrips supply and countries worldwide struggle to find doses. Bavarian Nordic has an "ongoing dialogue" with the FDA on how to expand those doses' shelf life.
| | | The FDA published draft guidance Monday, laying out additional details for drugmakers, doctors and researchers on regulations governing how firms can charge for drugs under an investigational new drug application. The FDA said Monday it would hold an Endocrinologic and Metabolic Drugs Advisory Committee meeting on Oct. 31 to discuss Ipsen Biopharmaceuticals' new drug application for palovarotene capsules for the prevention of heterotopic ossification in certain people with fibrodysplasia ossificans progressiva. The rare genetic disorder can cause ligaments and tendons to essentially transform into bone, making movement nearly impossible, according to the National Organization for Rare Disorders. The agency also announced Monday it will hold a Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting on Nov. 2–3 to examine the Center for Drug Evaluation and Research's quality management maturity program as well as its plan to expand the knowledge-aided assessment and structured application over the next five years.
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