NIH nominee likely to be pressed on march-in rights
Among the subplots surrounding Monica Bertagnolli's nomination for NIH director is how Senate health committee Chair Bernie Sanders uses confirmation hearings to press for answers on march-in rights to lower drug costs.
Why it matters: NIH has a key role in deciding if there's justification for the government to take over a drug patent and license it to other manufacturers in order to lower the price.
- Progressives have been agitating for the Biden administration to use the option for the first time and crack down on what they regard as patent abuse.
- But NIH in March rejected a petition to break the patent of the prostate cancer drug Xtandi, saying the treatment was widely available to the public and that march-in rights weren't an effective way to lower the price.
Where things stand: Sanders, who'll preside over hearings on the nomination as HELP Committee chairman, has said he will "strongly oppose" any major federal health agency nominee who isn't prepared to significantly lower drug prices.
- "The time is long overdue for fundamental changes in the way that our federal agencies ... relate to drug companies," Sanders wrote in a letter to President Biden last month.
- Those concerns could complicate the confirmation process while Republicans voice criticisms of the agency's funding of gain-of-function research and other lawmakers press the administration on lagging efforts to study long COVID. All of the factors could have a bearing on the agency's funding in fiscal 2024.
What we're watching: The Biden administration is reviewing march-in authority, with an interagency working group developing criteria, including price, to justify making such a move.
- The timetable for Bertagnolli's nomination could also slide into the summer as Congress deals with the debt limit, spending bills and other matters.