US FDA

Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.

A new congressional report on the public health response to the COVID-19 pandemic underscores that the FDA and its top managers may be in the hot seat.

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission’s search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs.

Pulling a product that was granted an emergency use authorization is easier than pulling a fully licensed vaccine, which could place Pfizer and Moderna’s COVID-19 vaccine pediatric indications at risk, along with Novavax’s vaccine in all age groups.

The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.

The expected nominee for FDA commissioner has not been very kind to the agency in his public statements and President-elect Donald Trump appears to be urging him to shake things up.

Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.

Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.

The US FDA’s Peter Marks told the Jefferies meeting that scientific leadership will be protected and that the agency wants to do more to help the sector accelerate innovation.

Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.

Expected HHS Secretary nominee Robert F. Kennedy Jr.'s dislike of user fees and interest in major FDA reforms could come to a head in the 2027 PDUFA reauthorization.

Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS, and FDA Commissioner Robert Califf’s request that industry help preserve the agency status quo.

The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.

In the second part of the Pink Sheet’s interview with the former senior FDA official, Woodcock says her push to create a rare disease drug approval pathway that wouldn’t require a randomized controlled trial will not return the agency to “an anecdote standard” or cause a downward creep in the evidentiary standard for approval.

Donald Trump’s victory in the US presidential election once again is creating a potentially unsettling transition process for the FDA. While it is far from clear that the new administration actually will want to disrupt the agency, there are several ways it could happen.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make to the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.

Former Trump adviser Tomas Philipson anticipates the FDA will undergo a deregulatory push during President Trump’s second term and emphasize speeding drugs to market.

Despite the recent anti-vaccine rhetoric in the final weeks of the Trump campaign, pulling an established safe and effective product off market would be difficult. But there’s little to stop political interference in approvals.

OCE Director Rick Pazdur celebrated 25 years at FDA by moderating a panel of five former commissioners. Topics included political challenges with the job and the ‘most memorable’ controversy they faced while in office.