FDA prepares for more leadership changes as President Trump nominates Dr. Heidi Overton for commissioner
President Trump announced his nomination of Heidi Overton, M.D., Ph.D. to be the next FDA commissioner on his Truth Social platform August 20, calling the deputy director of the White House Domestic Policy Council “a ROCKSTAR in my administration.” Dr. Overton is currently the Deputy Assistant to the President for Domestic Policy, a role she’s held since January 2025. Before that, she was chief policy officer and vice chair for the Center for a Healthy America at the America First Policy Institute, and she was a White House Fellow from 2019–2021. She helped lead the administration’s response to the 2026 Central Africa Ebola outbreak. A native of Gallup, New Mexico, she earned a BA in health, medicine, and human values from the University of New Mexico, an MD from UNM’s School of Medicine, and a PhD in clinical investigation from Johns Hopkins Bloomberg School of Public Health. She’s board-certified in public health and general preventive medicine. Her nomination was anticipated for the last several weeks as the Administration seeks to permanently fill the role currently held by Kyle Diamantas, who has been serving in the role since mid-May. Diamantas’ short tenure has seemingly brought stability to the agency, and senior leaders have prioritized many issues of concern during this time, namely the agency’s strategy for approving new therapies for rare diseases. Diamantas can serve in an acting role until early December, according to federal law. Overton’s nomination drew immediate opposition from Senate Democrats, who claim her stalwart support for the Administration’s healthcare policies and her support for increased FDA scrutiny of the abortion drug mifepristone, make her unacceptable. The Republican chair of the Senate Health, Education, Labor and Pensions (HELP) Committee—which will cast the first vote on her nomination—Sen. Bill Cassidy (R-LA) has expressed early concerns about her ability to run a complex agency like the FDA and her support for what he calls the President’s “nonsensical” executive order on vaccines. Cassidy will not be in the Senate beyond January, as he was defeated in the Republican primary after sparring with President Trump. Therefore, he is feeling no pressure to appease the White House. Several news outlets also cited her advocacy for the President’s “most favored nation” drug pricing policies. If her nomination advances out of the Senate HELP Committee it would then require a vote by the entire Senate. Overton’s challenge will be to keep almost all Republican senators’ support (she can only lose 3 Republican votes). Confirmation hearings could come in late September, however, given the packed legislative calendar when the Senate returns from recess on September 14, that is unlikely. Regardless of the timeframe, expect the confirmation process to be dramatic, especially leading up to the pivotal November midterm elections. The confirmation process could also end up being part of Congress’ lame duck session, which will run from November 9 – December 18.
New federal newborn screening strategy announced; Advocates anxiously await details on how it would work
While newborn screening for heritable (genetic/inherited) diseases is considered one of the U.S. public health system’s biggest success stories, the process (which is handled at both the state and federal levels) is far from perfect. Detecting conditions early is critical to delaying disease progression and implementing a comprehensive treatment strategy. Currently the federal government recommends testing for 64 conditions through its Recommended Uniform Screening Panel (RUSP). Most states test for all 64 conditions, but some do not. Many of these conditions are “silent” at birth — a baby can look completely healthy while carrying a metabolic, hormonal, or genetic disorder that will cause serious harm if untreated. Screening catches these before damage occurs. Oftentimes, there’s a narrow window where intervention can prevent or drastically reduce harm. In April of 2025, HHS disbanded the federal advisory panel that was charged with making recommendations of new conditions to be added to the RUSP. While concerning, advocates were hopeful that the Trump Administration would introduce a new, less bureaucratic process in its place. It took more than a year, but on August 20 the the federal Health Resources and Services Administration (HRSA) announced the federal government’s new NBS RUSP strategy – including a new stakeholder workgroup that will be run through the Association of Public Health Laboratories (APHL). APHL will receive a grant from HRSA to identify potential new conditions, investigate available testing and convene stakeholders—with the end goal of making recommendations of new conditions to add to the RUSP. The recommendations would be submitted to the HHS Secretary for final approval. Outside of details included in the Federal Register posting, several questions remain unanswered. APHL will host a newborn screening symposium in October, where additional details on the stakeholder workgroup are expected. Stakeholder response has been cautious, but generally positive. On the surface, this newly announced process should eliminate some of the bureaucracy and lead to speedier reviews and RUSP additions. In the midst of the current uncertainty within the federal newborn screening strategy, Congress must pass the Newborn Screening Saves Lives Act before the end of 2026. This legislation reauthorizes many federal efforts to promote newborn screening, including grants to state, parent/provider education and laboratory quality and surveillance.
It’s time to reauthorize PDUFA: How messy might the process get in 2027?
The Prescription Drug User Fee Act (PDUFA) lets the FDA collect fees from drug manufacturers to fund the review process for new drug applications, in exchange for FDA committing to review-time performance goals. It’s reauthorized every 5 years, most recently as PDUFA VII (FY2023–2027, signed into law September 2022). PDUFA fees from manufacturers fund roughly 65-70% of the FDA’s human drug review budget. Since the current authorization runs through FY2027, PDUFA VIII negotiations are already underway to have a package ready before that expires. Public meetings kicked off last summer and a series of stakeholder meetings with FDA officials, patient organizations and the biopharma industry continue, with reportedly good progress. Once the negotiations formally wrap up later this year, FDA will transmit the final package to Congress, where legislation to formally reauthorize PDUFA will be discussed, debated and hopefully passed on time. Over the past two decades, the PDUFA reauthorization process (while time-consuming and complex) was relatively straight-forward. The goal: A “skinny” PDUFA reauthorization that did not deal with larger policy issues related to drug pricing or other controversial issues. Congress attempted to add additional policy to the last PDUFA reauthorization legislation, but, in the end, cooler heads prevailed. Given the increasingly polarized political environment, many observers expect some members of Congress to attempt to add potentially harmful provisions to the legislation. Additionally, HHS Secretary Robert F. Kennedy, Jr. has argued in the past that the user fee funding mechanism gives pharmaceutical companies undue influence at the FDA. In the meantime, policymaker education on the importance of PDUFA and its role in ensuring efficient reviews and approvals of innovative therapies is ramping up. This is especially important since many members of Congress were not in office when previous PDUFA reauthorization bills were passed. The Biotechnology Innovation Organization (BIO) has some helpful PDUFA fact sheets outlining the history of the program and its importance. You can access those BIO resources here.
Health Policy Snippets
- Congress seeks a path forward on the ever-expanding 340B program. Everyone knows the current drug discount program is unsustainable (double-digit growth every year!), but how do we address it? The Trump Administration is favoring a rebate model approach, but new bills in Congress head in a different direction. Two bills were introduced in August that seek to eliminate the rebate model over time, but add crucial clarification and limits to the program—especially in regard to transparency and reporting, contract pharmacies and “child sites”. A House bill— The bipartisan SECURE 340B Act (H.R. 9599)—delays rebate models for four years and regulates contract pharmacies. A Senate bill–the bipartisan SUSTAIN 340B Act—aims to end HHS rebate pilots within a year via a neutral data clearinghouse to assist agency in monitoring. Both major bipartisan bills protect the rights of covered entities to use contract pharmacies, pushing back against manufacturer limits. However, both the House and Senate bills would codify covered entities’ use of contract pharmacies while enacting audits of entities that use a large number of contract pharmacies — so they protect the basic right to use contract pharmacies but pairs that with a new audit mechanism targeting high-volume contract pharmacy users. Both approaches introduce heightened reporting, registration, and compliance structures for participating entities and child sites to prevent duplicate discounts and diversion.
- IRA’s Medicare drug price negotiation is here to stay. Only one case attempting to block further implementation of Medicare drug price negotiation remains after the U.S. Court of Appeals for the Fifth Circuit rejected a lawsuit last week against the Inflation Reduction Act program by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Texas-based National Infusion Center Association and the D.C.-based Global Colon Cancer Association last week. The appellate court ruling marks the 25th straight loss for the drug industry in its efforts to prove the drug price negotiation program, as it’s been carried out, violates the Constitution and will result in weakened innovation for future prescription treatments and cures.
