|
|
|
M T W Th Fri |
23 May, 2025 |
|
|
|
|
|
|
It's Memorial Day in the US on Monday, so we won't be sending newsletters then. Have a great long weekend! |
|
Alexis Kramer |
Editor, Endpoints News
|
|
|
|
 |
CMS Administrator Mehmet Oz at the podium with President Donald Trump on May 12, 2025 (Mark Schiefelbein/AP Images) |
|
by Max Bayer
|
President Donald Trump unofficially asked CMS Administrator Mehmet Oz to lead the administration’s talks with drugmakers to lower prices, pushing his "most favored nation" policy. “I’d like to ask Oz in particular, because you and I know each other,” Trump said. “He's a very tough hombre, this one, he's tough as hell. And so if
you can lead the group — and it's not going to be easy — you're going to have to get in and you're going to have to fight.” The president’s comments came at the conclusion of an event Thursday unveiling the MAHA commission report on the rise of chronic diseases in the US. Trump began to unload on pharmaceutical companies who rely on the US economy to buoy their revenue, in addition to other countries that have
kept low prices. |
|
|
|
|
by Drew Armstrong, Anna Brown
|
The US Customs and Border Protection warned drugmakers against trying to evade import rules by misrepresenting the value of their products, in what appears to be an effort to head off a tactic the industry is considering ahead of the Trump administration's pharmaceutical tariffs. In a statement Thursday, the agency said that "declaring incorrect value on import or export documentation submitted to CBP is considered trade evasion, and CBP will pursue any violations to the fullest extent possible." The statement doesn't specifically mention tariffs but appears aimed at drugmakers who might try to circumvent or limit them. Endpoints News reported Thursday that drug developers may be considering using a principle known as the "first sale" rule, which could let them decrease the value of a drug declared at the border, lowering any tariff duty they would have to pay. |
|
|
|
|
|
by Zachary Brennan
|
Nearly one out of every 20 staff in the FDA offices that oversee drugs and biologics are gone after the Trump administration cut thousands of agency roles and offered buyouts, according to an analysis by the investment bank Bernstein. To conduct the review, the bank downloaded an online directory of HHS staff from April 15, and a second copy from May 15, and compared listings of workers at CDER and CBER. It identified 456 CDER or CBER employees — 4% of CDER and 6% of CBER — who no longer appeared in the directory and presumably no longer work at the centers. "We believe these exits will put further strain on an FDA that has
already shown signs of declining productivity," the Bernstein analysts said, pointing to missed PDUFA dates (and subsequent approvals) for both the Novavax Covid-19 vaccine and the Nucala COPD label expansion. |
|
|
|
|
by Alexis Kramer
|
The Trump administration has been barred from carrying out its sweeping plan to restructure and downsize the Department of Health and Human Services, following a court order that also applies to about 20 other federal agencies. The late Thursday decision by a California judge extends an order halting HHS Secretary Robert F. Kennedy Jr.’s plan, which called for con&s |
|
|