Potential FDA fallout from the mifepristone case

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

Mar 24, 2023 View in browser   By David Lim and Katherine Ellen Foley With Megan R. Wilson Driving the Day One of two FDA-approved pills used for abortions could be pulled from the market depending on a court ruling that's expected soon. | Charlie Neibergall/AP Photo AWAITING THE MIFEPRISTONE DECISION — Federal Judge Matthew Kacsmaryk in Texas is expected to make a decision any day now on whether the FDA exceeded its authority in granting accelerated approval to abortion pill mifepristone more than 20 years ago. The case could acutely hamper access to the most common type of abortion for millions of women nationwide. And fallout for the FDA could be for the long term. If Kacsmaryk sides with the plaintiffs, some legal experts fear it could set a precedent for courts to overturn the agency’s approval of other drugs the FDA has approved. “You could have scientific decisions overturned by nonscientists,” said a former senior FDA official, who was granted anonymity due to concern about their physical safety. “That undermines the value of the agency and the professional staff.” Other lawyers have argued that Kacsmaryk doesn’t have the legal authority to revoke mifepristone’s approval. A brief filed in February by lawyers on behalf of law firm Covington and Burling said: “An order requiring FDA to withdraw its approval of mifepristone immediately would conflict with FDA’s statutory mandate” of being the only entity that can order an approved drug be withdrawn from the market. At most, the lawyers argue, the ruling could require the FDA to begin the process of withdrawing the drug from the market. The FDA can only pull a drug’s approval if there is evidence it is unsafe or ineffective, and it is required to hear from the drug’s manufacturer. The process could take years. Mifepristone is one of two pills taken to end pregnancies up to 10 weeks, though it has other treatment uses. Years of post-marketing data show it is effective more than 99 percent of the time and has a fatality rate of less than a thousandth of a percent. It is the most common form of abortion in the U.S. The second pill is misoprostol, which can be used alone to end pregnancies, though it is not the preferred drug. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Happy peak bloom season for those of us in the beltway, especially to Stumpy, who is doing his best. Help us do our best by sending news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with Ruth Reader, who breaks down TikTok CEO Shou Chew's grilling on Capitol Hill yesterday and lawmakers' concerns about national security threats and what they see as the site’s corrupting influence on young people. Listen to today’s Pulse Check podcast In Congress SENATE PANEL ADVANCES PBM BILL — GOP concerns about legislation reigning in pharmacy benefit managers may stop it from becoming law, even though the Senate Commerce Committee advanced the bipartisan bill on Wednesday, Megan reports. The bill would prohibit certain PBM practices, including spread pricing in which a PBM charges a health insurance plan more than it reimburses a pharmacy for a drug. It allows exceptions for PBMs that pass all drug discounts, known as rebates, to health plans and disclose more information, such as certain costs, discounts, fees and payments they receive. But it also gives the Federal Trade Commission power to enforce the bill, a sticking point for some Republicans already wary of FTC Chair Lina Khan, who they believe has overstepped her authority. FDA Commissioner Robert Califf is set to appear before a Senate subcommittee next week to discuss the agency's fiscal 2024 funding request. | Joe Raedle/Getty Images APPROPRIATIONS AHEAD — FDA Commissioner Robert Califf will advocate for his agency’s fiscal 2024 ask before the House Appropriations Subcommittee with oversight over FDA funding next week, Chair Andy Harris (R-Md.) told POLITICO. The longtime cardiologist will testify Wednesday at 1 p.m. Subcommittee ranking member Sanford Bishop (D-Ga.) said Thursday the agency’s ask for $372 million in additional taxpayer funds “certainly is worthy of consideration” but cautioned there will be discussion about “accountability and how the funds should be used.” PROMISES MADE, PROMISES KEPT? Moderna CEO Stéphane Bancel made the trek to Capitol Hill on Wednesday and sparred with senators over his company’s planned price hike for its Covid-19 vaccine. Patent fight: The NIH sent Sanders a letter on March 17, which asserts that three NIH scientists “are co-inventors” of Moderna’s vaccine and were “integral members of a collaborative team of scientists working to design and produce” it. Bancel said Moderna disagrees with the NIH assessment and is working within the rules of the U.S. intellectual property system. Separately: Sen. Rand Paul (R-Ky.) and Bancel also traded blows over the risk/benefit profile of the Moderna shot for young men versus the risk of myocarditis from a Covid infection.   DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID.     Eye on the FDA FDA ADVISERS VOTE ON ALS DRUG — The FDA’s external neurological drug advisory committee voted 9-0 Wednesday in support of granting accelerated approval to a Biogen ALS drug. Tofersen, which lowers levels of a protein called neurofilament light chain, would likely result in a clinical benefit for patients with a certain type of amyotrophic lateral sclerosis, Katherine reports. Though the panel voted 5 - 3 with one abstention that Biogen had not yet provided enough evidence that tofersen benefits ALS patients, required for full FDA approval, it noted that the drug lowered levels of neurofilament light chain in late-stage trials. The FDA is slated to make a decision on the drug by April 25; though it doesn’t have to side with its advisers, it usually does. NEW DIGITAL HEALTH FRAMEWORK — On Thursday, the FDA published a new framework for digital health technology data used in regulatory decisions for drugs and biologics. “This type of data collection can expand access to underrepresented and diverse patient populations and improve trial retention rates by enhancing convenience for trial participants and reducing the burden on caregivers,” the FDA said in a statement. PATIENTS APPEAL XTANDI PETITION DENIAL — A group of people with cancer asked HHS on Thursday to overturn an NIH denial of a petition to use “march-in rights” on prostate cancer drug Xtandi, a step they argue would allow generic competition and lower prices. “Clearly, this is a case about ‘reasonable terms’ and the question is: can a company charge U.S. cancer patients three to six times more than they charge residents of other high-income countries for a drug invented on U.S. federal government grants?” the patients write in the appeal. NIH denied the original petition this week, a blow to liberal groups, including Public Citizen and Families USA, who argue returning the drugmakers’ patents to the government would rapidly lower the price of the Pfizer and Astellas Pharma drug. “NIH’s analyses in response to the petition request have found Xtandi to be widely available to the public on the market,” wrote Lawrence Tabak, who is performing the duties of the NIH director. “In addition, given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.” Quick Hits SCOTUSblog’s Eric Fraser previews Monday’s oral arguments for the Amgen Inc. v. Sanofi patent dispute over cholesterol-lowering antibodies before the Supreme Court. Pharma Moves Qiagen CEO Thierry Bernard is the newly elected chair of the AdvaMedDx board of directors. Supergoop! hired boutique lobbying firm Brumidi Group to work on “issues related to sunscreen and skin cancer prevention policy,” according to newly filed disclosures. Document Drawer The Government Accountability Office published a report on Thursday about the field of regenerative medicine and its workforce.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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