CCAGW Submits Comments on PAHPA Reauthorization to Senate HELP Committee
Letters to Officials
July 7, 2023
Chairman Bernie Sanders
Ranking Member Bill Cassidy, M.D.
U.S. Senate Committee on Health, Education, Labor, and Pensions
428 Senate Dirksen Office Building
Washington, D.C. 20510
Dear Chairman Sanders and Ranking Member Cassidy,
On behalf of the more than one million members and supporters of the Council for Citizens Against Government Waste (CCAGW), I am submitting comments in response to the July 3, 2023, Senate Health, Education, Labor, and Pensions (HELP) Committee press release regarding the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The comments are related solely to the request for feedback by the staff of Committee Chairman Bernie Sanders (I-Vt.) regarding an outside of the staff-level agreement policy to require that all Biomedical Advanced Research and Development Authority and Centers for Disease Control-supported products “be sold to the Federal Government or in the U.S. commercial market at the lowest price among G7 countries (Canada, France, Germany, Italy, Japan, and the United Kingdom) and at a reasonable price.” According to the press release, “this policy has not been agreed to.” CCAGW urges you to agree to keep this policy out of the PAHPA reauthorization.
Price controls on biopharmaceuticals will lead to fewer treatments and cures and undermine intellectual property. The “most favored nation” provision in the proposal, which would base prices on drugs being sold in other countries, is both seriously flawed and would be ineffective. The U.S. is the global leader in biopharmaceutical research and development for many reasons, including the lack of price controls that stifle innovation in other countries.
The impact of price controls on future cures and treatments was made clear shortly after the Inflation Reduction Act (IRA), which included price controls, was signed into law. Alnylam and Eli Lilly both announced the termination of research and development for cancer drugs.
The initial guidance proposed by the Centers for Medicare and Medicaid Services for implementing the price control provisions of the IRA, according to an April 23, 2023, letter from Sen. Mike Crapo (R-Idaho) and Rep. Cathy McMorris Rodgers (D-Wash.) would exacerbate the impact of the IRA by impeding innovation, weakening intellectual property protection, and hurting new drug research. They wrote that, “the guidance treats federal financial support at any stage of drug discovery or development as grounds for further price manipulation by the Secretary under the program, resulting in a de facto expansion of so-called ‘march-in’ authority, as referenced, but never imposed, under the Bayh-Dole Act. This effort comes despite consistent rejections, including by the Biden Administration, of attempts to rely on federal funding for a drug as grounds to impose price controls.” These same arguments apply to the policies being proposed by Chairman Sanders, who continues to attempt to increase government control over healthcare and move the U.S. closer to socialized medicine.
Universities and non-profits are successfully creating new discoveries and transferring that knowledge to new and existing enterprises. A May 6, 2022, Heartland Forward report noted, “Since the passage of the Bayh-Dole Act more than 40 years ago, the U.S. has developed a model of formal university technology transfer that has served as a blueprint and an exemplar for the rest of the world. By granting universities the intellectual property rights over discoveries from federally funded research, Bayh-Dole motivated universities and their faculty members to take an active role in commercialization.” The outside of the staff-level agreement proposal by Chairman Sanders is his latest effort to undermine Bayh-Dole and set price controls on the pharmaceuticals that would be developed from the transfer of technology. Doing so would reserve the 40 years of documented, critical progress made in the commercialization of federally- funded university research.
Price controls, most favored nation, and undermining technology transfer under Bayh-Dole are a devastating combination for future treatments and cures that will be needed in the next pandemic, or for any other reason. These provisions should remain where they are now, outside of the PAHPA staff-level agreement, and should not be included in any healthcare legislation considered by Congress. CCAGW appreciates your consideration of these comments and urges you to reject Chairman Sanders’ proposals.
Sincerely,
Tom Schatz
President, CCAGW