Collection of March-in Framework Comments

On February 6, 2024, the period for public comment regarding the Biden Administration’s “Request for Information Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” concluded. More than 50,000 public comments were submitted to regulations.gov, many of which highlighted the importance of march-in rights being used to protect patients, consumers and taxpayers against prescription drug price gouging.

This page compiles links to several comments from experts and groups representing patients, consumers, workers, physicians, and more:

Agency and Congressional Comments

• Federal Trade Commission (HTML | PDF) 
• Sens. King and Warren and Rep. Doggett, joined by Sens. Baldwin, Blumenthal, Booker, Brown, Fetterman, Klobuchar, Markey, Merkley, Sanders, Van Hollen, and Welch, and Reps. Balint, Beatty, Bishop, Bowman, Bush, Carter, Casar, Castro, Chu, Clarke, Cleaver, Cohen, Danny Davis, DeLauro, Deluzio, DeSaulnier, Dingell, Espaillat, Evans, Garamendi, C. Garcia, S. Garcia, Goldman, Green, Grijalva, Hayes, Hoyle, Jackson Lee, Jacobs, Jayapal, Kaptur, Khanna, Kim, B. Lee, S. Lee, Leger Fernandez, Magaziner, McCollum, McGovern, Mfume, Nadler, Napolitano, Norton, Ocasio-Cortez, Omar, Payne, Pingree, Pocan, Porter, Ramirez, Raskin, Schakowsky, Schiff, Sherman, Takano, Thompson, Titus, Tlaib, Tokuda, Trone, Vargas, Velázquez, Waters, Wilson (HTML | PDF)

Academic Comments

• Aaron S. Kesselheim, MD, JD, MPH, Professor of Medicine, Brigham and Women’s Hospital/Harvard Medical School, Program On Regulation, Therapeutics, And Law with Anushka Bhaskar, M. Phil., Research Assistant, Program On Regulation, Therapeutics, And Law (PDF)
• Nikhil Chaudhry, BA, Melissa Barber, PhD, Anthony So, MD, MPA, Ravi Gupta, MD, MS, Joseph S. Ross, MD, MHS, and Reshma Ramachandran, MD, MPP, MHS, researchers and physicians at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRIIT) (PDF)

Civil Society Organization Comments

• Robert Sachs, prostate cancer patient and Xtandi march-in petitioner (PDF)
• Public Citizen (individual comments) (HTML | PDF)
• Multi-group comments from Public Citizen, ACA Consumer Advocacy, American Federation of State, County & Municipal Employees (AFSCME), AIDS Healthcare Foundation, Alliance for Retired Americans, American Family Voices, Beta Cell Action, California Alliance for Retired Americans (CARA), Center for Popular Democracy, Congregation of Our Lady of Charity of the Good Shepherd (U.S. Provinces), Consumer Action, Health Care Voices, Health Global Access Project, Labor Campaign for Single Payer, Medicare Rights Center, MomsRising, National Advocacy Center of the Sisters of the Good Shepherd, National Committee to Preserve Social Security and Medicare (NCPSSM), National Nurses United, NETWORK Lobby for Catholic Social Justice, People’s Action, Public Interest Patent Law Institute, Revolving Door Project, Rise Up WV, Salud y Farmacos, Service Employees International Union (SEIU), Social Security Works, T1International, United Food and Commercial Workers International Union (UFCW), Universities Allied for Essential Medicines, WV Citizen Action (HTML | PDF)
• American Federation of Labor and Congress of Industrial Unions (AFL-CIO) Tech Institute (PDF)
• Families USA (HTML | PDF)
• Universities Allied for Essential Medicines (UAEM) (HTML | PDF)
• U.S. PIRG (HTML | PDF) 
• T1International (PDF)
• Knowledge Ecology International re: Transparency of March-in Proceedings (HTML | PDF) 
• Knowledge Ecology International re: Bayh-Dole Rights and Cases of Mixed Patent Landscapes (HTML | PDF)
• Knowledge Ecology International re: “Available to the Public on Reasonable Terms.” (HTML | PDF)
• Knowledge Ecology International re: Bayh-Dole Letter to the Washington Post and the Legislative History of the Act. (HTML | PDF)