This Week at FDA: Biden administration turns to “march-in” rights to combat high drug prices

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web.

This week, the big news is the Biden administration’s proposal to invoke “march-in” rights to rein in the high cost of prescription drugs. These march-in rights would be leveraged for patents developed using federal funds.

On Thursday, the Department of Commerce’s National Institute of Standards and Technology issued a framework that describes the factors that a federal agency may consider when deciding whether to exercise march-in rights under the 1980 Bayh-Dole Act. This law enables universities, small businesses or non-profits to retain ownership of patents for inventions made with federal funding.

NIST said the framework aims to “provide clear guidance to an agency on the prerequisites for exercising march-in, and, if those prerequisites are met, on facts to be gathered by the agency and factors to consider in determining whether to march-in.” It also aims to “ensure that decisions to exercise march-in support the policy and objectives of Bayh-Dole.” The framework is also meant to “encourage the consistent and predicable application of the law’s march-in authority and “balance the need to incentivize industry investment in the development and commercialization of subject inventions with the need to promote public utilization of subject inventions.”

The action is the latest attempt to get the federal government to use its statutory authority to respond to the soaring cost of pharmaceuticals.

Legislators back in in 2016 called for the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding (RELATED: Lawmakers urge HHS to Exercise ‘March-in” Rights to Fight Higher Drug Costs, Regulatory Focus. 11 January 2016).

Many in industry oppose the effort. The Biotechnology Innovation Organizations (BIO) noted the proposal could stymie federal research in new drug developments.

“Using the Bayh-Dole Act’s march-in process as a mechanism to control prices is a dangerous precedent to set,” according to a statement from BIO. “The move would create yet another element of uncertainty within the biotech industry at a time when policy makers have been increasingly adding obstacles to innovation. This type of policy would discourage the exact type of private-public sector partnerships that the Bayh-Dole Act was designed to encourage, and it would undermine a valuable piece of the drug discovery process.”

In other news, Alliance for a Stronger FDA reported in its Friday update that negotiations on FY 2024 appropriations for FDA and other agencies are continuing, albeit at a slow pace. Senate Appropriations Chair Patty Murray (D-WA) announced that legislators are “stuck” without an agreement on top-line spending levels. Staff for Senate Majority Leader Chuck Schumer (D-NY) and House Speaker Mike Johnson (R-LA) are reportedly negotiating these spending levels.

Drugs and Biologics

This report in Bloomberg notes that FDA sought to block the Pentagon’s effort to independently test certain generic drugs used to treat military personnel following quality problems associated with some generic drugs. The Pentagon in August chose to have a private lab, Valisure, test some of these drugs available to military personnel and their families, two years after Kaiser Permanente started a similar testing program with the lab. According to the article, FDA officials “cast doubt on Valisure's methods and, according to multiple government officials, soured a Biden administration effort this year to introduce third-party testing more widely.”

In other news, FDA announced the approval of two milestone treatments, Casqevy and Lyfgenia the first cell-based gene therapies to treat sickle cell diseases (SCD) in patients 12 years and older. Casqevy is the first therapy using CRISPR/Cas9 gene editing to be approved in the US.

FDA’s Oncology Center of Excellence has launched a new web page for its new Project Endpoint programs to enhance the use of endpoints in oncology drug development. The program also seeks to develop more established late endpoints and to coordinate early endpoint developments within oncology. The program will be headed by Nicole Gormley, director of the division of hematologic malignancies in the office of oncologic diseases at CDER.

FDA will be holding a meeting on 22 February 2024 on biomarker-driven drug development for allergic diseases. The agency also announced that it will hold a deep-dive meeting on 18 January 2024 on its Model-Integrated Evidence (MIE) industry pilot program for generic drugs.

Devices

The deadline for submitting a comment on the FDA proposed rule on laboratory developed tests closed on Monday. The agency received a whopping number of comments – more than 3,400 – after initial reports that it inflated the number of comments received after double-counting some responses.

According to the Office of Management and Budget, FDA submitted its Quality Management System Regulation (QMSR) final rule for clearance. The widely anticipated rule would harmonize FDA’s Quality System Regulation to the ISO 13485:2016 quality management system standard for medical devices.

FDA announced that its eSTAR program is now available for voluntary use for original PMAs, PMA panel track supplements, PMA real-time supplements and PMA 180-day supplements. eSTAR is an interactive PDF form that guides applicants though the process of submitting a medical device application.

This Week at FDA: Biden administration turns to “march-in” rights to combat high drug prices

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