August 09, 2024

Senators Warren, King, and Representative Doggett Urge Commerce, HHS to Strengthen and Finalize Guidance on “March-In” Rights to Protect Consumers From High Drug Prices

Following Supreme Court ruling overturning Chevron deference, lawmakers underscore unambiguous agency authority provided by Congress

“We urge you to follow the text and the legislative history of the statute … (and) not to be deterred by congressional Republicans who are seeking to hamstring your authority to lower drug costs for Americans.”

Text of Letter (PDF)

Washington, D.C. – U.S. Senators Elizabeth Warren (D-Mass.) and Angus King (I-Maine), and Representative Lloyd Doggett (D-Texas) wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Department of Commerce (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. Following the Supreme Court’s recent decision overturning the Chevron doctrine, the lawmakers highlighted Congress’ unambiguous delegation of authority and pressed Secretaries Becerra and Raimondo to strengthen and quickly finalize the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, a proposal to boost competition and lower prices for products, including pharmaceuticals, that American taxpayers helped pay to develop.

“In recent weeks, Republican members of Congress have sought to radically and incorrectly broaden the scope of the Supreme Court’s recent decision in Loper Bright Enterprises v. Raimondo to deter you from acting to protect consumers from high drug prices. But Loper Bright does not alter the plain terms of the Act, which clearly empower agencies with ‘march-in’ rights under Section 203 of the Bayh-Dole Act,” wrote the lawmakers.

The lawmakers underscored that the Supreme Court’s recent decision specifically preserves agency authority when a statute is unambiguous, urging the agencies not to be swayed by Republican lawmakers’ intentional misreading.

“Congress has explicitly and unambiguously delegated authority to your agencies to ensure that federal inventions, including pharmaceuticals and other medical products, developed using federal funds are ‘available to the public on reasonable terms.’ We urge you not to be deterred by congressional Republicans who are seeking to hamstring your authority to lower drug costs for Americans and we are reiterating the need for your agencies to immediately strengthen and finalize the proposed guidance issued under this statute so that Americans may receive the benefits that Congress intended,” wrote the lawmakers.

A recent analysis released by Senator Warren and Representative Doggett found broad public support for the Commerce Department’s proposed guidance on march-in rights, particularly from seniors and dozens of health care providers. Experts have conclusively shown that the federal government’s march-in authority allows agencies to address high drug prices.

Immediately following the Supreme Court’s ruling in Loper Bright, Senator Warren led the Senate response with the introduction of the Stop Corporate Capture Act, which would codify the Chevron doctrine and strengthen the rulemaking process to block corporations from attempting to influence government.

Senator Warren has long led efforts to use every tool available to the government to lower drug prices for the American people:

  • 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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