In a March 4 letter to National Institutes of Health (NIH) Director Monica Bertagnolli, MD, 17 Republican Senators described their opposition to draft guidance issued in December by the Biden administration regarding march-in rights [refer to Washington Highlights, Dec. 8, 2023].
The senators, including Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy, MD, (R-La.), Appropriations Committee Ranking Member Susan Collins (R-Maine), and Labor, Health and Human Services, and Education Appropriations Subcommittee Ranking Member Shelley Moore Capito (R-W.V.), stated in the letter that agencies, including the NIH, should not use their authorities to seize intellectual property and jeopardize the biomedical research enterprise. In addition, Cassidy issued a separate March 4 letter to the Government Accountability Office inquiring whether the draft guidance could qualify as a rule under the Congressional Review Act.
Since the announcement and release of the draft guidance, members of Congress have issued several letters voicing their support, criticism, and questions on various aspects of the proposal. In February, Sens. Elizabeth Warren (D-Mass.) and Angus King (I-Maine), and House Ways and Means Health Subcommittee Ranking Member Lloyd Doggett (D-Texas), along with several dozen lawmakers, issued a letter to Department of Health and Human Services and Department of Commerce leadership in support of the draft guidance. A bicameral, bipartisan group of 28 lawmakers led by Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) and Reps. Darrell Issa (R-Calif.) and Jake Auchincloss (D-Mass.), countered with a Feb. 21 letter urging President Biden to reconsider the proposal because it will “hamstring U.S. innovation to the advantage of our competitors and adversaries” and “all without even accomplishing its intended purpose of lowering drug prices.”
AAMC submitted two sets of comments asking the Biden administration to withdraw the draft guidance [refer to Washington Highlights, Feb. 2].