3 days ago
How much money will the FDA get next year?
Presented by
Driving The Day
FDA APPROPS INCHES FORWARD — House appropriators advanced a bill to fund the FDA for fiscal 2026 on a party-line vote out of a subcommittee Thursday — but the bill has a long path ahead before it potentially becomes law.
The topline number from the House bill aligns with President Donald Trump's budget proposal, which sought $6.8 billion for the FDA.
That includes $3.2 billion in direct appropriations, with the remainder coming from user fee revenue. But that represents roughly a $300 million cut in taxpayer funding compared to what the House Appropriations subcommittee sought last year for fiscal 2025 — a fact Democrats seized on during the hearing.
'We need to embrace transparency, and the FDA should be able to effectively and quickly share information,' said Rep. Sanford Bishop (D-Ga.), ranking member of the subcommittee, which is in charge of approving funds for the FDA. 'It needs the resources to do this.'
But Rep. Andy Harris(R-Md.), subcommittee chair, said the figure represents 'modest constraint' that will still allow Americans access to a safe food and drug supply.
But the Senate is likely to fund the agency at a higher level than the House.
The Republican senator in charge of FDA appropriations, Sen. John Hoeven (R-N.D.), told Prescription Pulse on Wednesday that Trump's proposal is a starting point.
'We now have the president's budget proposal,' Hoeven said. 'But we're going through our process now, and it will be different. … I think that you'll see when we bring it out that we adequately fund FDA.'
IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We can't help but notice the FDA's advice for the 'fellas' cautioning about over-the-counter sexual enhancement supplements.
Send your tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal).
POLITICO PRO SPACE — Need an insider's guide to the politics behind the new space race? From battles over sending astronauts to Mars to the ways space companies are vying to influence regulators, this weekly newsletter decodes the personalities, policy and power shaping the final frontier. Find out more.
Eye on the FDA
CELLS IN THE SPOTLIGHT — The FDA's top biologics regulator said Thursday he's willing to consider surrogate endpoints — markers believed to correlate with clinical benefit in a drug — as part of the agency's approach to approving rare-disease therapies by using 'gold-standard science and common sense.'
'We will rapidly make available therapies at the first sign or promise of biomedical success or action, but we're also going to follow up overall survival and quality of life on the back end,' Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, said during an agency roundtable on cell and gene therapies.
Prasad added he's often asked whether he's 'solely' interested in randomized controlled trials and said he's open to a variety of methodologies demonstrating a drug's benefit.
Background: His remarks come weeks after he and Commissioner Marty Makary unveiled a new Covid-19 vaccine framework that limits approvals of future formulation changes to people 65 and older and younger individuals with an underlying condition — and requiring new RCTs to prove the shots are safe and effective for young, healthy people.
Cell and gene therapies are often discussed in the context of rare diseases, as the technologies can address root causes instead of solely managing symptoms. But a condition's rarity hinders a company's ability to conduct a large-scale trial for a drug candidate, an issue with which regulators and industry have long struggled.
The FDA launched a rare-disease 'hub' last year to better align its drug and biologics regulators in their approach to considering those therapies for the market.
In Congress
O'NEILL CONFIRMED — The Senate voted to confirm Jim O'Neill to be HHS deputy secretary by a 52-43 vote Thursday — elevating an ally of early Trump backer and tech billionaire Peter Thiel, who previously worked as HHS principal associate deputy secretary during the George W. Bush administration.
O'Neill advocated in 2014 for the FDA to approve drugs once they're verified as safe, instead of also requiring effectiveness data — and was considered as an FDA commissioner candidate during President Donald Trump's first term.
REPUBLICANS PLAN SUPPLY-CHAIN HEARING — Top Republican health lawmakers on the House Energy and Commerce Committee want to reduce America's reliance on other countries for medicines and other health care products — and plan to hold a hearing Wednesday on how to incentivize a stronger supply chain.
'We have long been champions of policies that support efforts to onshore U.S.-based manufacturing and bolster our domestic supply chain, while, at the same time, strengthening our national security interests and economic goals,' E&C Chair Brett Guthrie (R-Ky.) and Health Subcommittee Chair Buddy Carter (R-Ga.) said in a news release.
Over in the Judiciary Committee, lawmakers are scheduled to examine the 'privacy and national security implications' of the 23andMe bankruptcy Wednesday at 10:15 a.m.
A BIPARTISAN PUSH? Lawmakers on both sides of the aisle indicated Wednesday that reauthorizing the FDA's over-the-counter user fee program could be a bipartisan effort — and the agency's over-the-counter sunscreen regulation has yielded bipartisan frustration.
Sen. Bill Cassidy (R-La.), chair of the Senate Health, Education, Labor and Pensions Committee, and other lawmakers questioned the FDA's top drug regulator why more drugs are not being moved to OTC status more rapidly — and Democrats questioned if job cuts at the FDA could impact new approvals.
Document Drawer
The FDA granted Florida a second extension for its drug importation program, extending the state's authorization to Nov. 6. But before drug imports can start, importers must file a pre-import request, which the FDA must grant, making it unclear whether the program will be used.
The top FDA medical device regulator, Dr. Michelle Tarver, met with Johnson and Johnson last week to discuss 'general medical device updates,' according to a public calendar disclosure. Also last week, the FDA deputy commissioner for strategic initiatives, Lowell Zeta, met with Eli Lilly to discuss 'pharmaceutical updates.'
The Government Accountability Office convened a roundtable of 19 experts to discuss how HHS can improve testing efforts during a public health emergency and released a report containing their nearly 100 recommendations.
WHAT WE'RE READING
STAT's Elaine Chen explores how Novo Nordisk's recent challenges competing with Eli Lilly relate to a cautious culture at the Danish drugmaker.
