At Global Forum, FDA Chief Clashes With Biotech Leaders Over Drug Prices
FDA Commissioner Robert Califf told the audience at the BIO 2023 convention, "The prices of drugs are too high in the U.S., and we have to come to grips with it." Critics complained about provisions in President Joe Biden's Inflation Reduction Act, dubbing it the “Innovation Reduction Act."
The Boston Globe:
FDA Chief’s Unwelcome Message To Biotech Execs: ‘Prices Of Drugs Are Too High’
The Food and Drug Administration’s top official Wednesday told a Boston gathering of biopharma industry leaders something few of them wanted to hear: Americans are paying too much for prescription medicines. ”The prices of drugs are too high in the US, and we have to come to grips with it,” FDA Commissioner Robert Califf told more than 1,000 people at the BIO 2023 convention. “People suffer health consequences [when] they don’t take their drugs because they’re trying to save money.” (Weisman, 6/7)
Stat:
‘We Don’t Agree’ On Drug Pricing, FDA Chief Tells Biotech Leaders
The drug industry has spent the past year speaking against new mechanisms that could limit how much governments or insurers pay for certain new medicines. Robert Califf, the Food and Drug Administration chief, walked on stage Wednesday and told a crowd of biotech leaders that drug costs needed fixing. (Mast, 6/7)
On the price of Alzheimer's treatments —
Stat:
Democrats Blast Biden Administration Over Alzheimer’s Drug Plans
Ahead of a major Food and Drug Administration meeting on a new Alzheimer’s treatment this week, several Democratic lawmakers are ratcheting up their criticism of how the Biden administration is planning to handle a potential approval this summer. (Cohrs, 6/7)
Reuters:
Eisai-Biogen Alzheimer's Drug Data Confirms Benefits, FDA Staff Says
U.S. Food and Drug Administration staff on Wednesday said data from a late-stage trial of Eisai and Biogen's Alzheimer's disease drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval. The FDA staff did not highlight any new risks linked to the drug, Leqembi, in documents released ahead of a meeting of a panel of external advisers on Friday that will discuss the companies' application for full approval. (Leo and Mandowara, 6/7)
In other news from Capitol Hill —
Roll Call:
House Republicans Quash CDC Request For More Authorities
As the Centers for Disease Control and Prevention lobbies Congress this summer to expand its data authorities and capabilities, it's clear the agency won't get much support from Republicans on the House Energy and Commerce Oversight and Investigations Subcommittee. (Cohen, 6/7)
Stat:
CDC Comes Under Fire For Inadequate Update On Its Covid Response
Republicans aren’t impressed with the Centers for Disease Control and Prevention’s reorganization plan, or its efforts to explain it. (Owermohle, 6/7)
Stat:
FDA Drug Review Delays Scrutinized By Sen. Cassidy
Sen. Bill Cassidy (R-La.) is looking into ways to speed up the Food and Drug Administration’s process for reviewing new drugs. “We’re at the reallllly early stages, like ‘can we talk about it?’ sort of thing,” the ranking Senate health committee Republican said about his potential interest in putting a stop to the FDA’s tactic for extending drug review deadlines. (Wilkerson, 6/7)
Roll Call:
Once Cushioned From Lawmaker Scrutiny, Hospitals See A Shift
While groups like the American Hospital Association, which represents about 5,000 hospitals and which spent $27 million on lobbying in 2022, remain incredibly powerful, inflation, rising health care costs and headlines about questionable business practices have put an unwelcome spotlight on the industry, especially as the Medicare trust fund nears its insolvency date. (Hellmann, 6/8)
Also —
The Washington Post:
USAID Cuts Food Aid Supporting Millions Of Ethiopians Amid Charges Of Massive Government Theft
The U.S. government is suspending food aid to Ethiopia after an investigation uncovered a widespread scheme to steal donated food, the U.S. Agency for International Development (USAID) said Thursday, a move that will affect millions of the world’s poorest people. Leaked documents given to donors and shared with The Washington Post indicate that the scheme was coordinated by elements within the government. (Houreld, 6/8)
Politico:
5 Takeaways From POLITICO’s Health Care Summit
Top government officials, lawmakers and health policy experts said the United States is well-positioned to move past the Covid public health emergency, better prepared for the next pandemic and poised to build on new technologies to improve care. But they also detailed continuing challenges — with health care costs, misinformation, racial disparities, mental health and drug addiction. (Paun, 6/7)
