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Trump 2.0
Amgen, BMS, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck & Co., Novartis and Sanofi will reduce prices of some drugs for Medicaid and offer reduced pricing through direct-to-patient platforms, among other concessions. In exchange, they will be exempted from tariffs.
After conducting more than 30 meetings for drugs, biologics and related issues in 2023 and 2024, less than half as many were held in 2025.
Former agency officials now representing industry worry that a deregulatory bent could be driving "Simple Reform" plan to merge all medical product and clinical research inspectorates and that specialist expertise gained in 2017 "Program Alignment" initiative will be reversed.
The US Centers for Medicare and Medicaid Services argued gender affirming care is not health care to help justify the new proposed rules. The argument could create a new opening for the federal government to go after other pharmaceuticals.
The FDA outlined its plans for “Sentinel 3.0,” including a data hub that would speed queries, during PDUFA VIII negotiations as industry questions whether user fee revenue should continue funding the program.
“We are not going back to Pasteur,” Pfizer CEO Albert Bourla said, criticizing the US government’s current anti-vaccine rhetoric.
Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.
As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.
Former agency officials who now represent industry worry that a deregulatory bent could be driving the "Simple Reform" plan to merge all medical product and clinical research inspectorates and that the specialist expertise gained in the 2017 "Program Alignment" initiative will be reversed.
“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.
Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.
At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.