Sanofi and Regeneron's 'extended negotiations' with FDA on requirements would later apply to Amgen's Repatha.
Praluent sponsors Sanofi and Regeneron Pharmaceuticals Inc. held negotiations with FDA over labeling language and post-marketing requirements that would set the benchmark for Amgen Inc.'s talks with the agency on Repatha a month later.
By virtue of being a few weeks ahead in the PCSK9 inhibitor approval queue – thanks to a priority review voucher – Sanofi and Regeneron had a hand in shaping what the labeled target population and post-approval safety studies
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
