FDA’s Block Of Mifepristone Access Is Unlawful, Federal Judge Rules
U.S. District Judge Jill Otake of Hawaii said in her ruling that the FDA violated the law by failing to provide reasonable scientific justification. She did not seek an immediate elimination of the restrictions.
AP:
Federal Judge Rules FDA Unlawfully Restricted Mifepristone Access
The U.S. Food and Drug Administration violated the law by imposing restrictions on accessing mifepristone, a medication for abortions and miscarriage management, a federal judge in Hawaii ruled Thursday. A lawsuit by the American Civil Liberties Union argues the FDA continues to overly restrict access to a safe medication without scientific justification. ACLU lawyers asked the judge to find that the FDA violated the law but didn’t seek an immediate elimination of the restrictions, which currently include special certification for prescribers and pharmacies and requiring patients to review a counseling form. (Sinco Kelleher, 10/30)
Updates on the 340B program and drug tariffs —
Modern Healthcare:
340B Rebate Pilot To Include Some Drugs From Abbvie, Merck: HRSA
The Trump administration Thursday released a slate of pharmaceuticals to be included in its 340B Drug Pricing Program rebate pilot. Under 340B, safety-net providers pay 25%-50% less for prescription medications. The program will test allowing drugmakers to pay rebates after purchase to qualifying providers, rather than discounting prices upfront. It will begin Jan. 1 and run for at least a year. (Early, 10/30)
Bloomberg:
Cigna Plan To End Drug Rebates Sparks Worst Selloff Since 2008
Cigna Group’s pledge to upend the way medicine is priced spooked Wall Street after the company warned the move would hurt profits in the next two years. The company’s shares closed down 17% Thursday, their worst one-day drop since 2008, after Cigna executives warned of the margin pressure during an otherwise routine earnings call. It’s evidence that the company’s plan to eliminate many drug rebates — opaque payments that fueled years of attacks on Cigna and its peers — will hit its bottom line. (Tozzi, 10/30)
Roll Call:
Senators Have Outline For Drug Price Program, But Vote Is Elusive
Lawmakers impatient with the lack of progress on a key health care issue — the long-debated need for changes to what’s known as the 340B drug pricing program — say they are closing in on legislation aimed at what they say are abuses in the program. (Hellmann, 10/30)
Bloomberg:
Antibiotics Must Cost More Than M&Ms, Sandoz Tells Governments
Drugmaker Sandoz Group AG called on European governments to protect local antibiotics manufacturing from a flood of cheaper Chinese products resulting from US tariffs. The Swiss company said the price of the key ingredient in penicillin — a lifesaving product for bacterial infections like pneumonia — has roughly halved lately as Chinese suppliers turn from the US to Europe, putting pressure on its business. (Doenecke, 10/30)
In other pharma and biotech news —
Stat:
Eli Lilly’s Weight Loss, Diabetes Drug Tops Keytruda As World’s Best-Selling Medicine
Merck, which has claimed bragging rights as the maker of the world’s best-selling drug, Keytruda, since 2023, has officially been surpassed by Eli Lilly. Lilly’s tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for obesity, saw $10.1 billion in sales in the third quarter, the pharma giant said Thursday, bringing year-to-date sales of the product to $24.8 billion. (Chen, 10/30)
The Wall Street Journal:
The Day Pharma’s Weight-Loss Gold Rush Intensified
Weight-loss drugs are propelling a new gold rush for the pharmaceutical industry. On Thursday, Eli Lilly delivered a surge in quarterly revenue thanks to its medicines, while Novo Nordisk, the other big player in the market, took the unusual step of lobbing an unsolicited multibillion-dollar bid for a weight-loss-drug startup that had agreed to sell to Pfizer. (Loftus, 10/30)
MedPage Today:
Expert Warns Of Irreparable Damage To Biotech Industry Unless Congress Acts
Gutting funding for key health agencies and terminating thousands of workers does nothing to ensure the future of the biotech industry, experts and Democratic lawmakers argued during a Senate health committee hearing on Wednesday. Sen. Bill Cassidy, MD (R-La.), chair of the committee, applauded medical innovations of the last few decades including vaccines against measles; treatments for obesity, Alzheimer's, melanoma, and other conditions; cures for hepatitis C; tests to detect diseases faster; and other interventions to improve patient outcomes. (Firth, 10/30)
Stat:
Insiders: Vinay Prasad 'Wreaking Havoc' At FDA After Return From Exile
A slow-boiling feud between Vinay Prasad and his staff at the Food and Drug Administration is threatening the future of the center that regulates the nation’s vaccines, biological products, and blood supply. (Lawrence, 10/31)
Also —
North Carolina Health News:
UNC Street Drug Scientist Awarded A ‘Genius’ Grant
At a time when the nation’s drug supply has become increasingly unpredictable, Nabarun Dasgupta uses what he calls “science in service” to bring some clarity to the chaos. Dasgupta has spent two decades using data to tell the story behind street drugs and their hidden dangers. He documents how people use those substances as a way of reducing the harm done by them. (Knopf, 10/31)
AP:
FDA Reports Recall Of Blood Pressure Medication Containing A Potential Carcinogen
The U.S. Food and Drug Administration says drug makers have recalled more than a half-million bottles of the blood pressure medication prazosin hydrochloride over concerns it may include a cancer-causing chemical. New Jersey-based Teva Pharmaceuticals USA and drugs distributor Amerisource Health Services issued voluntary nationwide recalls earlier this month of more than 580,000 bottles of various strengths of prazosine capsules, according to the FDA. (10/31)
