Warren, Doggett Lead Bicameral Charge to Lower Price of Popular Weight-Loss Drugs

September 26, 2024

Warren, Doggett Lead Bicameral Charge to Lower Price of Popular Weight-Loss Drugs

Members urge HHS to use existing legal authority to lower prices for the manufacturer's blockbusters Ozempic and Wegovy

Text of Letter (PDF)

Washington, D.C. - Senator Elizabeth Warren (D-Mass.) and Representative Lloyd Doggett (D-Texas) wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra asking him to lower the cost of vital weight-loss drugs by using the agency's existing legal authority to issue generic licenses for semaglutide, a prescription drug sold under the names Ozempic and Wegovy. The drug is commonly used to treat obesity and diabetes and is known for improving health and well-being.

HHS can lower prices using Section 1498, a more than a century-old statutory authority that permits generic competitors to license patented inventions in exchange for reasonable compensation to the brand-name manufacturer. By exercising this existing authority, the agency would help stabilize the health care market while meeting high consumer demands at more affordable prices.

"With a sticker price of up to $1,400 per month, patients can rarely afford Wegovy or Ozempic out-of-pocket and few insurance plans offer complete coverage due to the prohibitive cost," wrote the lawmakers. "A recent report from the Congressional Budget Office (CBO) estimated that the cost to cover these drugs would outweigh any savings from reduced utilization of associated health services and treatments."

"We do not need to waste taxpayer dollars, bankrupt health systems, or deny patients access to effective treatments. We can save consumers' health and be fiscally responsible by stopping Big Pharma monopoly abuse," the lawmakers continued. "There is no reason for Americans to pay the world's highest prices, substantially more than other wealthy nations, for the exact same medicines."

Additional signers include Senator Jeff Merkley (D-Ore.) and Representatives Eleanor Holmes Norton (D-D.C.), Sheila Cherfilus-McCormick (D-Fla.), Ro Khanna (D-Calif.), Pramila Jayapal (D-Wash.), Cori Bush (D-Mo.), Mark Pocan (D-Wis.), Jan Schakowsky (D-Ill.), Rashida Tlaib (D-Mich.), Mark Takano (D-Calif.), Rosa DeLauro (D-Conn.), Greg Casar (D-Tex.) and Barbara Lee (D-Calif.).

A coalition of more than 20 organizations also called on Secretary Becerra to take such action.

Senator Warren has long led efforts to lower the cost of prescription drugs for all Americans:

• In August 2024, Senators Warren and King and Representative Doggett wrote to Department of Health and Human Services Secretary Xavier Becerra and Department of Commerce Secretary Gina Raimondo reiterating their agencies' clear legal authority to use "march-in" rights under the Bayh-Dole Act to lower drug prices for Americans.
• In June 2024, Senator Warren and Representative Pramila Jayapal (D-Wash.) sent letters to eight pharmaceutical companies urging them to voluntarily de-list over 100 patents that the Federal Trade Commission (FTC) has determined may be improperly or inaccurately listed in the Food and Drug Administration's (FDA's) Orange Book, which would open opportunity for more competition and lower drug prices for Americans.
• In May 2024, Senators Warren, Sanders, Merkley slammed the Chamber of Commerce for opposition to the Biden administration's proposal to boost competition and lower drug prices.
• In February 2024, Senators Warren and King, and Representative Doggett led 75 lawmakers to urge the Biden administration to strengthen and finalize its guidance to protect taxpayers and lower prescription drug prices.
• In December 2023, in the wake of the Federal Trade Commission's (FTC) warnings about drug manufacturers' patent abuse, Senator Warren and Representative Jayapal 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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