The FDA’s lofty goals – POLITICO

The FDA’s lofty goals – POLITICO

FDA ELABORATES ON BIDEN’S 2024 BUDGET — On Monday, the FDA made public its justification for President Joe Biden’s fiscal 2024 budget proposal, which would boost the agency’s funding to $7.2 billion — $521 million more than fiscal 2023 levels. The agency’s funding comes from Congress-allocated tax dollars and industry user fees.

The White House budget request includes plans to strengthen the FDA’s regulatory authority. Below are some priorities that caught your host’s attention:

— Establishing contaminant levels in baby food and requiring more testing: The FDA aims to bolster its food safety program with a focus on protecting infants and young children by establishing limits of contaminants in foods. The agency also wants to require some testing for the foods and be able to remotely access testing records in fiscal 2024.

— Adjusting expiration dates to avoid shortages: The FDA wants to require drug manufacturers to submit data on the longest shelf-life possible for drugs in the event of a shortage. It also wants to issue monetary penalties to companies that don’t comply.

— Expanding its mandatory recall reach: The FDA wants to be able to mandate recalls for all human and animal drugs; currently, the agency can issue mandatory recalls for controlled substances, biologics and cosmetics. Even though the agency can ask drug manufacturers to voluntarily pull their drugs because of a safety concern, companies sometimes take extended periods before they act.

— Collecting e-cigarette user fees: The agency says most user fees it collects from tobacco manufacturers go toward the time spent regulating e-cigarettes, even though e-cigarette manufacturers don’t pay user fees. The FDA wants to collect fees from vape manufacturers, which it estimates would increase user fees by $100 million.

Staying grounded: In a divided Congress, it’s unlikely the White House’s budget will come to fruition without significant changes, though the FDA is usually insulated from the partisan battles fought over other budget priorities.

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE where we’re perplexed to learn that some urologists tell their patients March Madness is the perfect time to recover from a vasectomy. Send news and tips to David Lim ([email protected] or @davidalim) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with Michael Yang, a managing partner with OMERS Ventures, a global early-stage technology venture firm, about how the failure of Silicon Valley Bank — which had many health care and biotech startups among its client base — could hurt emerging health companies.

VETS GET BREAK ON ALZHEIMER’S DRUG — The Veterans Health Administration will cover Leqembi for patients with early Alzheimer’s disease, your host reports. The decision comes after the FDA granted Leqembi accelerated approval in January, despite the VHA declining to cover Aduhelm, a similar therapy to which the FDA granted accelerated approval in 2021.

What about nonveterans? The Centers for Medicare and Medicaid Services does not cover Leqembi, a monoclonal antibody thought to fight against the possible cause of Alzheimer’s disease. In 2022, CMS determined it would cover monoclonal antibodies for Alzheimer’s that received accelerated approval only for patients enrolled in a confirmatory trial. There are no ongoing trials for Leqembi.

BIG BUDGET BUMP FOR ARPA-H? Biden’s fiscal 2024 budget proposal calls for $2.5 billion in funding for the two-year-old Advanced Research Projects Agency for Health, POLITICO’s Ben Leonard reports. The request is up from $1.5 billion last year.

The boost comes alongside Biden’s proposed 12 percent increase for targeted research funding at HHS to $27 billion and a 23 percent proposed increase for experimental development funding for a total of $58 billion. Meanwhile, the Biden administration proposed cutting federal support for research without a specific focus by 1 percent or $170 million.

In a Monday briefing, ARPA-H Director Renee Wegrzyn said she wants to hire 15 to 20 program managers this year and expects to share more details on the agency’s development in the coming months.

THERAPY FOR RARE DISEASE APPROVED — Daybue, a new drug from Acadia Pharmaceuticals, received FDA approval to treat Rett syndrome for children and adults ages 2 and older.

Rett syndrome is a genetic condition that affects between 6,000 and 9,000 people in the U.S., mostly young girls. Patients with Rett syndrome develop normally for about 18 months but then regress and lose their motor and communication skills. No other treatments exist for the condition, and though patients typically live into adulthood, they require full-time care.

Daybue is a synthetic version of a naturally occurring brain protein. Acadia Pharmaceuticals set the cost of Daybue at $21.10 per milliliter, which it estimates will translate to $375,000 annually, and said it would be available by the end of April. In a statement, the company said the drug would be available at little out-of-pocket cost through its patient assistance program.

FDA ADVISERS TO DISCUSS PFIZER’S COVID ANTIVIRAL — On Thursday, the FDA’s Antimicrobial Drugs Advisory Committee will discuss Pfizer’s request for the agency to fully approve Paxlovid, an oral Covid-19 antiviral for people 12 and over at risk of developing severe disease. The company received emergency use authorization for Paxlovid in December 2021 and asked the agency to fully approve the five-day therapy in June 2022.

Doctors have prescribed Paxlovid more often than Merck’s Lagevrio, another antiviral pill, because it has higher efficacy rates. But the drug has known side effects, including drug interaction, such as with a high blood pressure drug.

PFIZER ACQUIRES CANCER THERAPEUTICS FIRM — Pfizer is expanding its footprint into cancer therapies with the acquisition of Seagan, a global biotech company focused on cancer drugs, Pfizer said Monday. Four of Seagan’s 12 FDA-approved cancer drugs use antibody drug conjugates, which target cancer cells, and the company is working to expand the use of those therapies for other cancers.

Pfizer will pay $43 billion to acquire the company, and the boards of directors of both companies unanimously support the merger.

U.S. JUDGE SIDES AGAINST MODERNA IN PATENT LAWSUIT — On Friday, Mitchell Goldberg, a judge in the U.S. District Court for the District of Delaware, ruled that Moderna had not proved that the U.S. government was the proper target of patent litigation brought by Arbutus Biopharma and Genevant Sciences. The companies sued Moderna last year over patent infringement on Moderna’s Covid-19 vaccine. Moderna has argued that the federal government was the rightful target of the litigation given that Moderna developed and manufactured the vaccine for the federal government.

Moderna responds: “We respectfully disagree with the Court’s decision,” Christopher Ridley, a Moderna spokesperson, said in a statement. “The government weighed in on the legal question at issue here and confirmed what Moderna has said all along: Arbutus and Genevant sued the wrong party in the wrong court for certain U.S. government vaccine sales. We are confident that fact discovery on this issue will support our position.”

Robert Zirkelbach is stepping in as the executive vice president of public affairs and strategic initiatives for the Pharmaceutical Research and Manufacturers of America. He returns to the trade organization after working in the same role at ExxonMobil’s global issue and advocacy division, POLITICO’s Megan Wilson reports.

Diabetes drug Ozempic and blood thinner Eliquis are among the drugs Wall Street and academic experts predict will be subject to Medicare price negotiations, report Michael Erman, Patrick Wingrove and Ahmed Aboulenein for Reuters.

For POLITICO Europe, Sarah-Taïssir Bencharif explains the circumstances it would take for global health authorities to call for human immunizations against bird flu.


The CDC ended its requirement for airline passengers flying to the U.S. from China to have a negative Covid test before entry.

The FDA put out final guidance Monday on enforcement policy for face shields, surgical masks and respirators during the Covid pandemic public health emergency set to end in May.

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