South OC Times

Last week, Congressman Darrell Issa (CA-48), Chairman of the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, led a bipartisan initiative to halt the implementation of a Biden Administration proposal. This proposal would allow the federal government to exercise march-in rights under the Bayh-Dole Act and weaken intellectual property in an attempt to control prescription drug prices.

The National Institute of Standards and Technology (NIST) issued this proposal, which gives the government authority to "march in" and remove intellectual property protections from innovators if certain price conditions are met.

In collaboration with Senator Chris Coons (D-DE), Senator Thom Tillis (R-NC), and Congressman Jake Auchincloss (MA-04), Issa sent a letter to the Government Accountability Office (GAO). The letter requests a comprehensive study on the potential long-term effects of NIST’s proposal on American citizens and U.S. innovation. A second letter was also sent to NIST urging them to postpone their proposal until GAO completes its study.

The letter addressed to GAO states:

"Although the proposed framework was developed with the laudable objective of reducing prescription drug prices, the facts tell a different story. A March 2024 National Bureau of Economic Research empirical study on the feasibility of using Bayh-Dole Act march-in rights to lower drug prices found that NIST’s proposed framework will have limited impact—only 2.5% of all drug products approved by the Food and Drug Administration between 1985 and 2022 could even be subject to full march-in rights. Several studies over the past decade have similarly concluded that successful march-in petitions would do little to lower drug prices."

"We are concerned that implementing the draft framework is likely to have negative consequences for U.S. innovation and global competitiveness, public-private partnerships created by the Bayh-Dole Act, and the U.S. economy."

The letter addressed to NIST states:

"As you know, patient-focused advocacy groups, public health groups, universities, and the leading U.S. trade association for generic and biosimilar prescription drug manufacturers all submitted comments to your office opposing the draft framework and raising concerns about its likelihood to undermine U.S. innovation."

"We also sent a letter to President Biden, with a copy to your office, urging reconsideration of the draft framework, which would undermine initiatives intended to revitalize American manufacturing and hamstring U.S. innovation to the advantage of our competitors and adversaries."

These letters follow a February letter sent by the coalition to President Biden discouraging the implementation of the proposal.