News Release

Is Big Pharma’s Dominance Through Bayh-Dole Act Finally Getting Scrutiny from Biden?

STAT News in “Biden’s executive order would pause a Trump rule forbidding march-in rights to lower drug costs” reports: “In a little-noticed move, the Biden administration has hit the pause button on a rule that would prevent the federal government from using a controversial legal provision for combating the high prices of products developed with taxpayer dollars.”

(Last week, STAT News reported: “Major pharmaceutical companies and trade groups helped fund the campaigns of more than 2,400 state legislators nationwide in the 2020 election.” STAT News focuses on health issues and is produced by Boston Globe Media.)

JAMES LOVE, james.love@keionline.org, @jamie_love
    Love is director Knowledge Ecology International, a not-for-profit non-governmental organization that “searches for better outcomes, including new solutions, to the management of knowledge resources.” KEI is focused on “social justice, particularly for the most vulnerable populations, including low-income persons and marginalized groups.”

    He said today: “The Bayh-Dole Act, passed in 1980, created a uniform policy for the management of patents on federally funded R&D. Among the provisions are some that can be used to increase competition and address abuses, such as excessive pricing. In the early 1990s, Congress pressed the federal government to curb high prices on federally funded drugs for HIV, cancer and rare diseases. In 1995, President Clinton announced he would no longer enforce reasonable pricing conditions in contracts. Since then, the NIH has rejected a number of petitions to use its rights to ‘march-in’ on patent rights, and grant licenses to generic manufacturers, when prices are excessive.

    “Universities and drug companies have lobbied aggressively and successfully for more than 20 years to prevent this from happening. There is a petition outstanding today by three prostate cancer patients for the government to grant a march-in request on Xtandi, a drug that costs $150k+ per year in the United States, and far less everywhere else. On Jan 5, 2021, NIST [National Institute of Standards and Technology] proposed a regulation to eliminate pricing as a grounds for a march-in request. The executive order put a hold on that provision, and now the Biden administration will have to rule on the Xtandi petition, which is before DoD. The precedent will be important for many other products.”