fda
The politicization of FDA
There’s a long history of the FDA being insulated from politics, but the agency is starting to feel the heat, Lizzy Lawrence writes. From Covid shots to autism treatments, FDA workers tell Lizzy that scientific evidence increasingly is taking a back seat to political priorities.
The story opens with an inquiry FDA scientists received from the agency’s drug center director, George Tidmarsh, asking about leucovorin, a generic drug that’s mainly used to alleviate side effects of cancer treatment. He’d seen some promising studies and thought the agency could find a way to approve it as an autism treatment.
That’s the opposite of how things are supposed to work, and the extraordinary request put FDA staff in a difficult position. They pushed back and reached a compromise with Tidmarsh in which the original maker of the drug would submit an application to approve the drug for a condition sometimes linked to autism that’s far more rare. Even that compromise was undermined by FDA Commissioner Marty Makary. Read more.
drug prices
Trump may get another drug-pricing tool while plowing ahead with MFN deals
The Senate last week took a big step toward passing legislation to restrict U.S. pharmaceutical and biotechnology companies from doing business with certain Chinese companies.
Lawmakers have been close to passing the BIOSECURE Act before, only to watch it fail. This time, the Senate withdrew a measure that had raised concerns among a few lawmakers who believed it unconstitutional.
Read more about what lies ahead and how the bill could give President Trump another way to twist the arms of drugmakers.
Meanwhile, Trump continues to use the threat of tariffs to get drugmakers to agree to align prices between the U.S. and other rich countries, a policy called most favored nation. On Friday, the White House announced an MFN deal with AstraZeneca, Daniel Payne and Elaine Chen report, after Pfizer announced a similar deal the week prior. Read more on the AstraZeneca deal.
medicare advantage
MA AI inquiry
Casey Ross got his hands on a letter that Sen. Richard Blumenthal (D-Conn.) sent to MA insurers pressing for details about their use of artificial intelligence tools amid reports that the companies are rapidly becoming more reliant on the technology to help make decisions about patients’ care and coverage.
Blumenthal asked UnitedHealth Group, Humana, and CVS Health to describe policies they’ve put in place since October 2024 to prevent AI tools from “unduly influencing” the work of clinicians.
In his correspondence to the insurers, Blumenthal cites a 2023 investigation by STAT that uncovered the widespread use of an algorithmic tool owned by UnitedHealth to cut off payment for patients seeking rehabilitative care to recover from serious illnesses and injuries. Read more.
maha
California to make school lunches healthier
A lot of Americans are concerned about how ultra-processed food affects their health — but there’s still debate about exactly what ultra-processed food is, which tends to muddy the conversation about a category that potentially includes everything from canned beans to Skittles. A new California law aimed at making school lunches healthier is particularly noteworthy for providing a legal definition. (STAT covered the bill when it was first proposed in March.)
The bill, signed by Governor Gavin Newsom on Wednesday, defines ultra-processed foods as those that contain both high levels of sodium, added sugar, or saturated fat as well as additives like stabilizers, emulsifiers, and artificial flavors. California’s health department will further narrow the definition for “ultra-processed foods of concern” based on factors like peer-reviewed scientific evidence and other state, federal, and international restrictions, with schools phasing out products that fall in the latter category over the next 10 years.
Health secretary Robert F. Kennedy Jr. and agriculture secretary Brooke Rollins announced plans this summer to provide a federal definition of ultra-processed foods, though there’s not yet a timeline for when that might be rolled out. — Sarah Todd