Back in March, the U.S. Department of Health and Human Services (HHS) and the Department of Commerce (DOC) announced efforts to pursue a whole-of-government approach to review its march-in authority as laid out in the Bayh-Dole Act, which promotes commercialization of research results, maximizes the potential for federally-funded technologies to become products, and serves the broader interest of the American public. HHS created and empowered a new interagency Working Group to develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies’ assessments.
Yes, you read that right – price -- and now it’s more than a maybe.
According to “unnamed sources” (as reported by Politico), “The Biden administration has determined that it has the authority to seize the patents of certain high-priced medicines, a move that could open the door to a more aggressive federal campaign to slash drug prices.”
The problem, the Bayh/Dole Act doesn’t consider price in its legislative intent for Federal march-in rights. And wishing it were so doesn’t make it so.
Ready for a Christmas surprise? The Commerce Department plans to issue a new framework spelling out factors that federal agencies should weigh in determining whether to take march-in action against expensive drugs or other individual products that were created with federal help. The price and availability of that product to the public are among the factors the department will recommend that agencies consider.
The White House has scrambled to highlight Biden's health accomplishments in recent days, after former President Donald Trump suggested he would repeal and replace the Affordable Care Act if elected in 2024.
Per Politico, “The Commerce Department and Department of Health and Human Services were already expected to issue their determination on the government's march-in authority in the coming weeks, the people familiar with the matter said. But the announcement was accelerated in the wake of Trump's comments, and officials are expected to cite it as evidence that Biden continues to search for new ways to lower prices.”
Just like the IRA’s price control codicils, this ill-considered effort will put another chill on drug development from those who really drive innovation – the biopharmaceutical industry. Will there be lawsuits arguing this federal power grab? Undoubtedly.
Alas, headlines for hyped and misleading “NIH-funded cures” are far sexier than those for “more money for drug regulation.” Pursuing misguided policies that siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society. The Working Group's bad advice would result in fewer medicines for patients and lost jobs at a time when our economy can least afford it.
Watch this space for more as the saga continues.
Yes, you read that right – price -- and now it’s more than a maybe.
According to “unnamed sources” (as reported by Politico), “The Biden administration has determined that it has the authority to seize the patents of certain high-priced medicines, a move that could open the door to a more aggressive federal campaign to slash drug prices.”
The problem, the Bayh/Dole Act doesn’t consider price in its legislative intent for Federal march-in rights. And wishing it were so doesn’t make it so.
Ready for a Christmas surprise? The Commerce Department plans to issue a new framework spelling out factors that federal agencies should weigh in determining whether to take march-in action against expensive drugs or other individual products that were created with federal help. The price and availability of that product to the public are among the factors the department will recommend that agencies consider.
The White House has scrambled to highlight Biden's health accomplishments in recent days, after former President Donald Trump suggested he would repeal and replace the Affordable Care Act if elected in 2024.
Per Politico, “The Commerce Department and Department of Health and Human Services were already expected to issue their determination on the government's march-in authority in the coming weeks, the people familiar with the matter said. But the announcement was accelerated in the wake of Trump's comments, and officials are expected to cite it as evidence that Biden continues to search for new ways to lower prices.”
Just like the IRA’s price control codicils, this ill-considered effort will put another chill on drug development from those who really drive innovation – the biopharmaceutical industry. Will there be lawsuits arguing this federal power grab? Undoubtedly.
Alas, headlines for hyped and misleading “NIH-funded cures” are far sexier than those for “more money for drug regulation.” Pursuing misguided policies that siphon funding from the groundbreaking medical research happening in the biopharmaceutical industry will have devastating consequences for patients and society. The Working Group's bad advice would result in fewer medicines for patients and lost jobs at a time when our economy can least afford it.
Watch this space for more as the saga continues.
