WASHINGTON — The Food and Drug Administration on Friday approved teplizumab, a type 1 diabetes drug developed by Sanofi, for children aged 8 and older with stage 3 diabetes. 

The drug was selected to go through a speedy review program launched last year by former FDA Commissioner Marty Makary, but the agency missed its goal date of April 21 to deliver a decision. 

STAT previously reported that Sanofi asked to pull its drug out of the program after former top drug regulator Tracy Beth Høeg disagreed with a staff decision to approve the drug. It’s rare for a center director, and particularly a political appointee like Høeg, to get involved in individual scientific reviews. 

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Below is a lightly edited, AI-generated transcript of the “First Opinion Podcast” interview with Dawn Zuidgeest-Craft. Be sure to sign up for the weekly “First Opinion Podcast” on Apple Podcasts, Spotify, or wherever you get your podcasts. Get alerts about each new episode by signing up for the “First Opinion Podcast” newsletter. And don’t forget to sign up for the First Opinion newsletter, delivered every Sunday.

Torie Bosch: So I get a surprising number of ideas for First Opinion by watching TikTok. It’s for work, I swear. Recently, I came across a video of a woman proudly sharing the fact that her mother, age 72, had just completed medical school and matched into residency. I had to talk to the septuagenarian to find out more about going to medical school at an age when most people have already retired. And much to my delight, she agreed.

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WASHINGTON — The Trump administration on Friday proposed to change a policy that is designed to prevent drugmakers from avoiding Medicare price negotiation by adding active ingredients to drugs. 

The policy is part of an annual proposed rule that establishes the process that the Centers for Medicare and Medicaid Services uses to choose the next 20 drugs and biologics for price negotiation. Those drugs will be announced by Feb. 1, 2027, and their negotiated prices will take effect in 2029. The administration also considered a similar policy last year but put off a decision to study it further.

Medicare must wait seven to 11 years after a product is approved by the Food and Drug Administration before it can negotiate its price, depending on the type of medicine. Biologics that are typically administered in doctor offices get more time than drugs taken orally. 

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