Warren, Doggett, King, 75 Lawmakers Urge Biden Administration to Lower Prescription Drug Prices
Washington, D.C.— U.S. Senators Elizabeth Warren (D-Mass.) and Angus King (I-Maine) and U.S. Representative Lloyd Doggett (D-Texas) led 75 lawmakers to urge the Biden administration to strengthen and finalize its guidance to protect taxpayers and lower prescription drug prices. The lawmakers submitted a public comment supporting the “Interagency Guidance Framework for Considering the Exercise of March-In Rights” and calling for changes to ensure increased transparency, oversight, and accessibility of medical products invented through taxpayer-funded research and development.
“Americans subsidize Big Pharma’s research and development, yet they pay some of the highest drug prices in the world,” said Senator Warren. “I’m glad the Biden Administration is standing up to Big Pharma’s price-gouging, and I urge the administration to strengthen and quickly finalize its guidance on march-in rights to lower drug prices and save lives.”
The Bayh-Dole Act permits agencies to license generic competitors on taxpayer-funded inventions under certain conditions, including when there is an unmet health or safety need. In December, the Biden Administration’s Interagency Working Group for Bayh-Dole released draft guidance on a framework for agencies to evaluate when to exercise its existing statutory authority, including when a product is unreasonably priced.
“We write to express our support for strengthening and finalizing the ‘Interagency Guidance Framework for Considering the Exercise of March-In Rights’ to protect the public’s health and safety by ensuring reasonable prices on taxpayer-funded inventions. We appreciate that the Administration has, for the first time, specified that price is a factor in determining whether a taxpayer-funded invention is accessible to the public. Reining in out-of-control prescription drug prices is one of the most pressing challenges facing the United States, and taxpayers are investing more than ever in biomedical research, sometimes funding 80 to 100 percent of the cost of developing a new medical product,” wrote the lawmakers.
“While we recognize the important role of the private sector in research and development and support the ability to make a reasonable profit, industry interests should not outweigh meeting health and safety needs for all consumers and providing accountability to taxpayers,” continued the lawmakers.
The lawmakers offered a set of detailed comments and suggestions on considerations for exercising march-in-rights, procedures for exercising march-in-rights, and implementation of march-in-rights.
Senator Warren has led efforts to use every tool available to the government to lower drug prices for the American people:
- In December 2023, in the wake of the Federal Trade Commission’s (FTC) warnings about drug manufacturers’ patent abuse, Senator Warren and Representative Pramila Jayapal (D-Wash.) sent letters to the CEOs of 8 pharmaceutical companies urging them to voluntarily remove sham patent claims improperly included in the Food and Drug Administration’s (FDA) “Orange Book” and end their unlawful practices that delay competition and drive up costs for patients and taxpayers.
- In December 2023, Senator Warren published an op-ed in Newsweek commending the Biden administration’s announcement that price can be considered in the government’s decision to march-in on a drug, effectively lowering drug costs, and calling on Americans to fight back against an industry that has been taking advantage of them for decades.
- In December 2023, Senator Warren issued a statement after the Biden administration announced it would issue guidance to federal agencies that would allow the government to seize patents of certain expensive drugs developed with taxpayer support to create more competition and lower prices.
- In December 2023, Senator Elizabeth Warren (D-Mass.) and Representative Jan Schakowsky (D-Ill.) reintroduced the Affordable Drug Manufacturing Act, bicameral legislation to address the skyrocketing price of prescription drugs and increase competition in the generic pharmaceutical market by establishing an Office of Drug Manufacturing within the Department of Health and Human Services tasked with manufacturing select generic drugs and offering them to consumers at a fair price that guarantees affordable patient access.
- In September 2023, Senator Warren and Representative Jayapal sent a letter to FTC Chair Lina Khan urging the FTC to issue a policy statement about the improper listing of drug-related patents in the FDA’s Orange Book.
- In August 2023, Senator Warren and Representative Jayapal sent a letter to FDA Commissioner Dr. Robert M. Califf, urging him to close loopholes that pharmaceutical companies have exploited to block generics from entering the market, keeping drug prices high and maximizing profits.
- In June 2023, Senators Warren and Angus King (I-Maine), and Representative Lloyd Doggett (D-Texas) sent a letter to Department of Commerce Secretary Gina Raimondo and Department of Health and Human Services (HHS) Secretary Xavier Becerra asking for information on the membership, process, timeline, and scope of work of the recently announced Interagency Working Group for Bayh-Dole.
- In April 2023, Senator Warren and Representative Jayapal sent a letter to Kathi Vidal, Director of the United States Patent and Trademark Office (USPTO), calling on USPTO to take immediate action and use its existing administrative authorities to help lower drug prices and hold pharmaceutical companies accountable for anti-competitive business practices.
- In February 2023, Senators Warren and Bernie Sanders (I-Vt.) and Representatives Jayapal and Katie Porter (D-Calif.) sent a letter to the USPTO, calling on the agency to give close scrutiny to any of Merck’s requests for new patents for Keytruda, a biological treatment used to treat cancer, citing new reports about Merck’s ongoing abuse of the patent system to protect its monopoly on the drug.
- In January 2023, Senators Warren and King and Representative Doggett led their colleagues in sending a follow-up letter to HHS, urging Secretary Becerra to exercise his authority to lower the price of cancer treatment drug Xtandi.
- In December 2022, Senator Warren and Representative Jayapal sent a letter to Director Kathi Vidal following up on their June 2021 letter about USPTO’s efforts to hold pharmaceutical companies accountable for anti-competitive business practices and tackle high drug prices.
- In June 2022, Senators Warren and King and Representatives Doggett, Joaquin Castro (D-Texas), Sara Jacobs (D-Calif.), and Porter led a group of 100 members from across the ideological spectrum to urge HHS Secretary Xavier Becerra to swiftly act and use his existing authorities to lower prices on critical prescription drugs.
- In April 2022, Senator Warren sent a letter to Secretary Becerra, sharing the findings from a letter that over 25 legal and public health experts sent to her outlining three powerful legal tools the Biden administration could use to lower drug prices.
- In March 2022, Senator Warren and her colleagues called out drug manufacturers for squeezing American families with rapid and widespread price hikes on prescription drugs.
- In February 2022, Senators Warren and King and Representative Doggett urged HHS to exercise its march-in rights for the life-saving cancer drug Xtandi to dramatically lower its price for millions of Americans.
- In June 2021, Senator Warren led a letter questioning PhRMA's lobbying efforts to block policies that would lower drug costs for millions of Americans.
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