Politics

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.

“The first time we have a contact with them, if and when someone complains, is not because you're in trouble, but you already have a pre-existing relationship,” says former Maryland state AG Doug Gansler.

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

In the wake of a US presidential election that saw Donald Trump returned to power, the US Association for Accessible Medicines has called for the next administration to take action to help support the generics and biosimilars market.

Biden’s order for proposed rules could boost support for Democrat Kamla Harris from undecided voters concerned about reproductive rights or for Republican Donald Trump from those who agree with his conservative stance on access to birth control, which he argues should be up to states to regulate. Proposed rules also could stir consumers not planning to vote to go to the polls.

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

The US Food and Drug Administration is undergoing seismic leadership changes, from the expected post-election departure of two-term Commissioner Robert Califf to the retirement of longtime Center for Devices and Radiological Health Director Jeff Shuren. What might the new management mean for the medtech industry? Silverman Group President and former FDAer Steve Silverman has some insight.

Instead of $5bn in 2025, the redesign could cost the federal government two to four times that amount, the Congressional Budget Office told Republican lawmakers. And the Part D premium stabilization demonstration will cost an additional $7bn, the office projected.

Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.