Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.
Senator Patrick Leahy, D-Vt., may have a tough time pushing through legislation to overturn the Supreme Court’s ruling last year that generic manufacturers cannot be held liable for inadequate label warnings. At least that is the view of Jay Lefkowitz, who represented generic manufacturers in that case, Pliva v. Mensing.
“I don’t think it’s likely to be a successful effort,” said Lefkowitz, a partner at Kirkland & Ellis. “It would...
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
