Issa Co-Leads Bipartisan, Bicameral Effort to Halt Biden Administration Exercise of "March-in Rights"

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

The proposal, issued by the National Institute of Standards and Technology (NIST), equips the government to “march in” and take intellectual property protections from innovators if certain price conditions are met.

In a joint effort, Issa alongside co-leads Senator Chris Coons (D-DE), Senator Thom Tillis (R-NC), and Congressman Jake Auchincloss (MA-04) sent a letter to the Government Accountability Office (GAO) requesting a comprehensive study on the potential ramifications of NIST’s proposal on American citizens and U.S. innovation in the long-term. Additionally, the authors sent a second letter to NIST urging the postponement of the proposal until GAO completes its study.

An excerpt from the letter to the GAO:

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, the public-private partnerships that the Bayh-Dole Act created, and the U.S. economy. Therefore, we request that you prepare a study on the below questions designed to determine the impact of the draft framework on U.S. prescription drug prices, U.S. innovation, and U.S. national interests. 

An excerpt from the letter to the NIST:

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. Given these concerns, implementing the draft framework without first studying its potential impacts would be unwise. We therefore ask NIST (and the administration) not to implement the draft framework or any other guidance for exercising march-in rights under the Bayh-Dole Act until GAO completes its study and transmits its findings.

These letters were sent in addition to a February letter the coalition sent to President Biden discouraging the implementation of the proposal.