Article Summary:
This week at the FDA, there are several notable updates across drug, medical device, and regulatory policy. Staffers have raised concerns that the Commissioner’s National Voucher Program (CNVP) is being used as a political tool by the Trump administration, alleging that vouchers were steered to companies with ties to the administration’s drug pricing agreements.
The FDA recently awarded CNVP vouchers to Merck for two drugs – an oral PCSK9 inhibitor and an antibody-drug conjugate – citing their potential to increase treatment access and reduce healthcare costs. However, the FDA Commissioner stated the agency has no plan to add a boxed warning to COVID-19 vaccines, contrary to recent reports.
The FDA finalized several new guidances this week, including accepting real-world evidence in medical device submissions without requiring patient-level data, and providing clarity on its bioresearch monitoring program. New draft and final guidances were also issued on improving clinical trial enrollment, especially for female participants.
On the drug and biologics front, the FDA updated standard operating procedures for sponsor meetings and refuse to file determinations. Key approvals include Milestone’s nasal spray for paroxysmal supraventricular tachycardia, Daiichi Sankyo’s breast cancer drug, and Rubraca for prostate cancer. The agency also issued a priority review voucher for a Barth Syndrome treatment.
Lastly, the FDA published meeting minutes on reauthorizing the Generic Drug User Fee Amendments, with industry proposals around review timelines and the complex generics program.