drug prices
Taming Trump?
During the GOP retreat, Trump also said drug pricing is a winning issue for Republicans.
The president is pleased with the deals he has cut with 14 drugmakers to voluntarily cut prices.
“We reduced the cost of medicine at levels that have never even been dreamt of before,” Trump said. “We should win the elections on just that thing, if we did nothing else and went home.”
But as many see it, pharma manipulated Trump, Damian Garde reports, even if it required some ring kissing. Damian talked to a bevy of analysts to explain how industry faced the administration’s threat of destabilizing tariffs and painful pricing policies, and came out on top.
Speaking on STAT’s podcast The Readout LOUD, Bruce Booth, partner at the venture capital firm Atlas Venture, said the companies that struck deals got off easy.
“When you declare that you’ve done an MFN deal on your portfolio, but then you really don’t have to restate your revenue forecast, what does that tell you?” he asked.
Read more about how the threat to pharma seems to have passed.
dietary guidelines
Cow-towing to beef and dairy interests
Some of the researchers who helped form the scientific basis of the new dietary guidelines have financial ties to the beef and dairy industries, as well as to food companies and other groups, Isabella Cueto and Sarah Todd report.
Kennedy and Make America Healthy Again leaders attacked nutritionists whose work informed the previous guidelines for their ties to special interests. And boy, are those nutritionists mad now.
“This is hypocrisy!” said Christopher Gardner, a Stanford nutrition scientist and member of the most recent advisory committee. Gardner drew criticism from MAHA leaders for accepting research funding from the plant-based meat company Beyond Meat.
Read more about the financial conflicts. And here’s the story by Elizabeth Cooney, Isa, and Sarah on the new inverted pyramid guidelines that encourage people to eat more meat and dairy products.
vaccine liability
Fuzzying liability protections
Kennedy’s allies hope the reduction of recommended childhood vaccinations makes it easier to win lawsuits against drugmakers, Chelsea Cirruzzo and Daniel Payne report.
The health secretary has long criticized vaccine liability protections and has himself challenged the safety of Merck’s human papillomavirus vaccine in court.
Liability shields have been in place for about 40 years. They may not be immediately lost, but some legal experts see the changes as a step toward making it easier to sue vaccine manufacturers over injuries believed to be caused by the shots.
Read more.
artificial intelligence
Relaxing the rules for wearables
The FDA is easing regulation of digital health products, according to Lizzy Lawrence, Mario Aguilar, Katie Palmer, and Brittany Trang.
The new approach appears to open the door to the unregulated use of generative AI products for certain medical tasks, such as summarizing a radiologist’s findings. It also relaxes the FDA’s stance on consumer devices.
The changes follow through on the administration’s promises to deregulate artificial intelligence and promote its widespread use. The FDA announced the new policy without giving the public a chance to comment. The dockets for both policies are open, so people can still offer feedback, but it will be after the fact.
Read more.
fda
Paranoia at FDA's biologics center
FDA’s biologics center director Vinay Prasad gave employees an ominous directive this week, according to internal documents viewed by Lizzy Lawrence.
"Please instruct all staff and personnel in your division to make their calendar visible to me," he wrote in an email to leaders in the center.
Prasad added that he wished to see all details of employees' calendar events so that his office could quickly schedule meetings with staff. "Please instruct staff that they are not to notify their supervisor of these meetings, nor meet beforehand to discuss," he added.
The mandate is notable given STAT's previous report showing that Prasad's management style, and his sudden ousters of at least seven senior leaders, has created an atmosphere of fear and paranoia among staff. Demanding full calendar transparency is an interesting choice in that context — particularly given the fact that Prasad's own calendar, according to internal images viewed by STAT, is hidden from most employees.