Trump health care order is a mixed bag for biotech

President Trump has issued a new executive order that takes aim at high drug prices and inefficiencies in Medicare.

In a notable victory for the biotech and pharma industries, the order directs HHS Secretary Robert F. Kennedy Jr. to work with Congress to address what drugmakers say is an imbalance in the law: that it gives small molecule drugs fewer years before they're subject to pricing negotiations with Medicare, compared to biologics, disincentivizing companies from investing in pills, critics say.

But the order also outlines a plan to expand drug price negotiations and calls for broader drug importation from Canada.

Read more about what's in the order from STAT's Tara Bannow and Anil Oza.

vaccines

First ACIP meeting of RFK Jr. era was largely procedural

Despite concerns that Robert F. Kennedy, Jr.'s new HHS leadership would derail vaccine policymaking, yesterday's meeting of the Advisory Committee on Immunization Practices proceeded mostly without incident, STAT's Jason Mast reports.

There were the usual deep dives into vaccine data — for Covid-19, Mpox, HPV, as well as shots for Lyme disease and cytomegalovirus. When the ongoing measles outbreak centered in Texas and New Mexico was discussed, the committee emphasized the importance of vaccinations but didn't directly invoke Kennedy's name.

"I find it absolutely devastating we're having this update today — there's no reason why we have healthy children dying of measles in the U.S. when this vaccine is amazing," ACIP chair Keipp Talbot said. "It's highly effective and has very long lasting immunity."

The committee will convene again today.

alzheimer's disease

Europe approves Leqembi for select Alzheimer's patients

From my colleague Andrew Joseph: After a bumpy road, Eisai and Biogen's Alzheimer's therapy Leqembi has won approval in Europe.

The authorization, announced yesterday by the European Commission, came after regulators initially recommended against the therapy's approval, citing the modest benefits — it can only partially slow the cognitive and functional decline caused by the disease — and the serious side effect risks that come with the treatment. But after an appeal, regulators revised their recommendation, saying that the benefits of Leqembi outweigh the risks for select patients, specifically those who do not have genetic variants that leave them at higher risk for the brain bleeding and swelling that medicines like Leqembi can cause.

The commission's approval was limited to the narrower patient group.

The back-and-forth reflects how regulators around the world are taking different approaches as they weigh the new class of Alzheimer's therapies that includes Leqembi. The medicines are the first that have shown they can slow disease progression, but only in a limited way. The brain issue they can cause — what's known as ARIA — can in rare cases be fatal. Notably, European regulators last month recommended against the approval of another, similar treatment, Eli Lilly's Kisunla. Both therapies are approved in the U.S.

POLITICS

House calls on 23andMe's Anne Wojcicki to testify

House Oversight Chair James Comer said yesterday that he was launching an investigation into national security and data privacy concerns stemming from the bankruptcy of 23andMe, whose collapse has prompted fears that the DNA data of millions of Americans could fall into the wrong hands — specifically the Chinese Communist Party.

The company filed for bankruptcy after a failed attempt by co-founder Anne Wojcicki to buy it back.

In a public letter, Comer is calling for Wojcicki to testify publicly on May 6.

"National security concerns about 23andMe and similar companies are not new," Comer wrote.

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