Today, the White House reportedly approved a plan for FDA Commissioner Marty Makary to depart after a little more than a year in the role, capping a tenure defined by internal turmoil, policy fights and strained relationships with both industry and policymakers. His leadership coincided with low staff morale, high-profile departures and repeated disputes over drug approvals, with critics pointing to inconsistent decision-making and growing political pressure on the agency.

It’s not yet clear when he will leave, and Makary was set to testify at a contentious hearing next week before the Senate Appropriations Committee to discuss the agency’s 2027 budget.

The instability and inconsistency of the agency was visible this week with products going through accelerated pathways. This week, STAT reported that Sanofi moved to withdraw its type 1 diabetes drug from the Commissioner’s National Priority Voucher (CNPV) pilot program after a high-ranking official, Tracy Beth Høeg, intervened in what staff had supported as an approval. At the same time, the agency quickly awarded and approved a Partner Therapeutics’ bispecific for bile duct cancer, underscoring how rapidly some decisions can advance under the CNPV framework.

Combined with reports of leadership shakeups, internal clashes and erratic decision-making, these instances underscore how policies meant to streamline the FDA are instead contributing to an environment that industry increasingly views as unpredictable and unsustainable.

– Megan Hickey, Managing Director

A White House report this week claims that the Trump administration’s 17 drug pricing deals with pharmaceutical companies are projected to yield $529 billion in savings over the next 10 years. The report also states that discounts for the Medicaid program would result in $64 billion saved over the next decade.

The analysis, which was done by the White House Council of Economic Advisors with no outside experts, raised more than a few eyebrows across the industry.

Critics noted that the projected savings are based on the agreements continuing in perpetuity, while the reported most-favored nation deals feature terms that expire after three years. Others said the report was unverifiable given that none of the MFN agreements have been made public.

However, the report did provide the most details on the MFN program to date, including a public definition of MFN pricing as the second-lowest price available among a select group of peer high-income nations.

The Trump administration looks to reassure Americans about healthcare affordability, an issue that has had staying power as the top worry for voters despite rising costs for gas and consumer goods amid the Iran War.

But it remains to be seen what the actual impact of MFN and other government price setting initiatives – such as Medicare price negotiations – do for the price Americans are actually paying.

– Rachel Bridges, Senior Director

Last month, CMS announced that a plan for insurers to shoulder the cost of obesity treatments in Medicare would not proceed as planned after the two parties failed to agree to terms. That won’t stop the Trump administration from launching its own program to bolster its affordability agenda.

While CMS continues to work on the BALANCE Model, administrators have prepared a temporary solution. The Medicare GLP-1 Bridge is a demonstration that will provide enrollees of Medicare Part D plans with certain GLP-1s medicines at a “predictable and affordable” cost of $50 per month.

The program begins on July 1, 2026, and will run through December 2027 (a year longer than originally planned), at which point a more permanent solution would theoretically take its place. Notably, the program requires prior authorization filed by a physician using eligibility criteria based on body mass index and co-existing health conditions.

The Bridge demo is seen as a key political message for President Trump ahead of the 2026 midterm elections – where affordability is expected be a core issue for voters.

“Now think of that, $50 a month. So, it was $2,300, now it’s $50 – and the $1,300 doesn’t cover a whole month. So it’s really even more than that,” Trump said during a recent 90-minute speech at The Villages in Florida.

Demand for GLP-1s continues to skyrocket, with Eli Lilly’s Mounjaro now topping Merck’s Keytruda as the world’s top-selling drug. In turn, employers report that the rapid uptake of obesity treatments are driving rising healthcare costs, according to the Business Group on Health.

– Andrew Wishon, Editor-in-Chief

• May 11-15 – annual meeting, American Society of Gene & Cell Therapy
• May 12 – event to share “lessons from Europe’s loss of biopharma leadership,” Information Technology and Innovation Foundation
• May 13 – hearing to review the President’s FY27 FDA budget request featuring Commissioner Makary(?), Senate Appropriations

• “If drug developers and investors cannot rely on a predictable, science-based FDA process to govern how products reach patients, they will be far more hesitant to move forward, especially in areas that could become politically contested. You can imagine the slippery slope: If one state decides it doesn’t like a medication…it could try to use the courts to impose nationwide restrictions or barriers.” – Grace Colón, STAT
• “We had hoped Dr. Makary would restore credibility to an agency damaged by the Biden team’s pandemic equivocations and lack of transparency. But Dr. Makary’s deceptions about the agency’s drug reviews and rejections would make Anthony Fauci blush.” –Editorial Board, The Wall Street Journal
• “Branding antidepressants as classes of drugs to be avoided will reduce the likelihood that others will pursue the evidence-based treatments from which I have benefited, and which have allowed me to build a career researching health insurance barriers and inequities.” – Miranda Yaver, MS NOW
• “Most episodes of care are not analogous to ordering something in a restaurant or buying an airline ticket. Patients usually don’t know in advance which tests or procedures they wind up needing, especially in emergencies or for complex diseases and conditions. As such, it’s unclear how much transparency would assist patients in a material way.” – Joshua P. Cohen, Forbes

• The whiplash of two federal court rulings on abortion pill access have thrown providers and patients into uncertainty, as changes to mifepristone restrictions create confusion in both red and blue states. Axios: Abortion pill rulings cause whiplash and confusion.
• HHS is promoting a shift away from antidepressants toward therapy and other non‑pharmacological approaches, drawing pushback from clinicians who caution that SSRIs remain a key evidence‑based treatment for many patients. NPR: Psychiatrists say RFK Jr.’s take on SSRIs is an ‘oversimplification’ of the problem.
• Dr. Nicole Saphier, the radiologist nominated to be U.S. surgeon general, has no prior substantial relationship with HHS Secretary Kennedy and a history of criticizing some of his policies. CNN: Trump’s new surgeon general pick deepens MAHA-MAGA rift.
• Kennedy’s HHS‑branded podcast is drawing scrutiny for its unconventional early episodes, featuring celebrity guests and loosely connected health topics. WIRED: RFK Jr.’s New Podcast Is as Weird as You’d Expect.
• Obesity has overtaken oncology as the largest driver of late‑stage pipeline value, underscoring a major shift in pharma innovation. Fierce Pharma: GLP-1 boom pushes oncology off top spot for late-stage pipeline value: Deloitte.
• CVS is expanding adoption of lower‑cost biosimilars across its formularies, prioritizing interchangeable alternatives to branded drugs in a push to reduce patient costs and improve access to therapies. Fierce Healthcare: CVS to expand biosimilar formulary adoptions to improve affordability, accessibility.
• Gilead’s twice‑yearly HIV prevention shot is seeing increased uptake following its launch, but insurance coverage gaps and patient cost‑sharing requirements continue to limit broader adoption. Reuters: Use of Gilead’s HIV prevention shot rises, but US insurance gaps remain.
• Challenges in the UK pharma industry extend beyond U.S. MFN pricing policies, with industry leadership warning that broader pricing and market access dynamics are undermining confidence and investment. Pink Sheet: UK Pharma Woes ‘Not All About MFN,’ Says ABPI Trade Body Chief.