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March-in rights, which have never been used before, allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder does not make them available to the public on reasonable terms.
Xtandi’s wholesale cost is between $160,000-$180,000 per patient a year.
Patient group the Union for Affordable Cancer Treatment first filed a petition calling on the NIH to use its authority to lower the drug’s price in March 2016.
The NIH said in a letter made public on Tuesday that its analyses in response to the petition found the prostate cancer treatment was widely available.
“NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” the letter said.
Pfizer and Astellas were not immediately available for comment. The companies are expected to have combined revenue from Xtandi of more than $2 billion this calendar year, according to data from Refinitiv.
March-in rights were introduced as a safeguard in the Bayh-Dole Act of 1980 which allows the inventors to retain ownership of inventions developed with public funds and hold patents, as is the case with Xtandi.
Progressive lawmakers in the Democratic Party have been calling on President Joe Biden’s administration to use its march-in authority to lower drug prices.
The Department of Health and Human Services also denied a petition for a congressional hearing concerning potential price gouging on the drug, which was developed with government funding, Representative Lloyd Doggett, the top Democrat on the House’s Ways and Means Health Subcommittee, said in a statement.
The U.S. Department of Health and Human Services (HHS) and the Department of Commerce (DOC) said on Tuesday they would undertake a review of the government’s march-in authority as laid out in the Bayh-Dole Act.
