Policy
The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
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A spokesperson for the Department of Health and Human Services refuted the claim, made Thursday on social media by ACIP Vice Chair Robert Malone, calling it “baseless speculation.”
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”
Health Secretary Robert F. Kennedy Jr. has become increasingly unpopular among several government officials, largely as a result of his antivaccine rhetoric and actions. Other contentious issues reportedly include the approval of an abortion pill and other controversial FDA decisions.
The senator, who has long advocated for expanding access to experimental therapies, reportedly called the FDA’s request for a sham surgery–controlled Phase 3 trial for uniQure’s Huntington’s disease gene therapy “bureaucratic idiocy.”
The settlement, which requires Moderna to pay the plaintiffs $950 million upfront plus up to $1.3 billion in contingent commitments, is an outcome “better than feared,” according to analysts.
One of the two new members of the CDC’s Advisory Committee on Immunization Practices questioned the safety of COVID-19 vaccines before the Texas Senate in 2021.
The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful.
This week’s Capitol Hill meetings come on the heels of rejections of ultra-rare disease drugs developed by Biohaven and Saol Therapeutics. Physicians and patient groups implored the FDA to expedite these treatments.
FDA Commissioner Marty Makary presented a new idea to staff this week: bonus payments for employees that complete regulatory review processes faster than expected.