Makary gets some critical reviews after first town hall

In his first address to FDA staff, Commissioner Marty Makary made sweeping declarations about the need to challenge scientific norms and identify the root causes of chronic disease, but he said little about specific plans for the agency and about the mass layoffs that roiled staff earlier this week, according to a recording of the meeting obtained by STAT.

Several FDA employees said they were disappointed by Makary's speech and found it to be "tone-deaf" given the upheaval at the agency. They also felt it didn't touch on one of the FDA's core jobs: making safe and effective medicine available to the public.

Staff were also introduced to members of Makary's leadership team, including Tracy Beth Høeg as his special assistant. Høeg has co-authored studies with Makary on Covid-19 vaccines and was an adjunct associate professor at the University of Southern Denmark.

politics

Trump official intervenes in Novavax vaccine decision

Speaking of the FDA — Politico reported that Sara Brenner, FDA's principal deputy commissioner, paused the approval process of Novavax's Covid-19 vaccine to ask for more data.

This move is highly unusual, Politico writes, since political FDA appointees typically follow the advice of career staff on drug approvals in order to protect scientific decision-making from political interference. The news comes shortly after health secretary RFK Jr. ousted the FDA's top vaccine regulator, Peter Marks.

pharma

Pharmaceuticals are spared from tariffs, for now

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries that his administration sees as engaging in unfair trade. The White House wrote in a fact sheet, though, that pharmaceuticals are exempt from these tariffs.

The tariffs announcement initially caused confusion and anxiety among biotech investors as they sought to understand the impact on pharmaceuticals. The XBI sank in post-market trading yesterday before then rising again.

Does this mean that the biopharma industry won't be affected, though? Not necessarily.

It's not yet clear if these new tariffs could affect areas of drug manufacturing beyond the final pharmaceutical product, such as API components, Jefferies analysts wrote. They pointed to a recent BIO survey that found that nearly 90% of U.S. biotechs rely on imported components for at least half of their FDA-approved products.

And as I mentioned in yesterday's newsletter, tariffs on pharmaceuticals may still come soon. Reuters recently reported that drugmakers expect tariffs to be inevitable, but they're lobbying the president to phase in the tariffs.

politics

Trump firings delay an FTC suit against PBMs

Ongoing health issues are being affected not only by layoffs at HHS but also firings at the FTC.

My colleague Ed Silverman reports that a lawsuit that the FTC brought last year against the largest pharmacy benefit managers over insulin pricing has been delayed because the FTC doesn't have enough commissioners to hear the case. (President Trump last month fired two Democratic commissioners.)

The move to pause the case is "a gift to the PBMs," former FTC chair Lina Khan wrote on the social media site X. She had pushed for investigations into PBMs over not only their interactions with insulin makers, but also — more broadly — their opaque role as middlemen that take rebates from drugmakers in exchange for creating lists of medicines covered by insurance.

gene therapy

EMA orders hold on Sarepta Duchenne studies

The European Medicines Agency has requested a temporary hold on clinical trials of Sarepta's gene therapy for Duchenne muscular dystrophy after Sarepta reported last month that a teenage boy taking the treatment died.

Roche, who has signed a deal with Sarepta to commercialize the therapy outside the U.S., told patients about this development in a letter this week. Roche said it's pausing enrollment and dosing of participants at European and U.K. study sites, and is continuing to monitor safety among patients who are already enrolled.

Sarepta's therapy, called Elevidys, was approved after intense debate at the FDA as officials and reviewers disagreed over how strong the evidence was and whether it warranted making the drug available for patients facing a fatal disease with few other options.

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