Davidson News

Davidson News

Biden administration, Pharmaceutical prices, Healthcare, Bayh-Dole Act, Legal controversy

Controversial Move Sparks Legal Debate and Opposition from Republicans

In a bold move aimed at addressing rising pharmaceutical prices, the Biden administration has announced plans to exercise authority over patents of certain high-priced medications developed with federally funded research. This decision, outlined in a regulatory framework issued by the Department of Health and Human Services and the Department of Commerce, is designed to utilize the Bayh-Dole Act of 1980, allowing the government to claim “march-in” authority on patents and potentially license these inventions to other entities.

Biden Administration Unveils Plan to Seize Patents of Federally Funded Drug Research to Tackle Pharmaceutical Prices
Biden Administration Unveils Plan to Seize Patents of Federally Funded Drug Research to Tackle Pharmaceutical Prices

The White House, in a press release, emphasized the belief that medications funded by taxpayers should be reasonably accessible and affordable. The regulatory move challenges the Trump administration’s previous proposal, which sought to prevent the government from using this authority based solely on price considerations. The Biden administration cites concerns about market competition as the reason for not finalizing the proposed rule from the previous administration.

However, this decision has triggered strong opposition from Republicans, with Senate Health, Education, Labor, and Pensions Committee ranking member Bill Cassidy asserting that the Biden administration lacks the legal authority for such use of march-in rights. Cassidy argues that this move could stifle American healthcare innovation and deprive millions of Americans of potential lifesaving cures and treatments.

The bipartisan legislation being leveraged by the administration, the Bayh-Dole Act, was co-authored by former Democratic Indiana Sen. Birch Bayh and former Republican Kansas Sen. Bob Dole. Cassidy contends that the authors did not intend for their act to be used for price manipulation of pharmaceutical products, citing a 2002 opinion editorial in the Washington Post by Bayh and Dole.

The editorial emphasized that the primary purpose of the Bayh-Dole Act was to encourage private-sector collaboration in public-private research efforts rather than setting government-dictated prices. The law, according to the authors, allows for patents to be revoked only when the private industry collaborator fails to successfully commercialize the invention, not based on commercial product pricing.

While critics argue that the Biden administration’s actions are anti-free market, the administration has consistently defended its efforts to address the soaring costs of healthcare, including its Medicare Drug Price Negotiation Program. This program, which sets Medicare Part D prices for expensive prescription drugs, has faced legal challenges from pharmaceutical companies questioning its constitutionality.

As the Biden administration pushes forward with its plans to seize patents, legal battles and debates over the government’s role in pharmaceutical pricing are expected to intensify.

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