May 30, 2024

New Analysis by Warren, Doggett Reveals Broad Public Support for Commerce Department’s Proposed Guidance on March-In Rights to Lower Drug Costs

As Big Pharma Fights Efforts to Reduce Drug Prices, New Analysis Reveals over 85% of Public Comments Support Agency Efforts to Lower Prices on Taxpayer-funded Drugs

Lawmakers Highlight Support from Health Care Providers, Seniors

Text of Letter (PDF)

Washington, D.C. — Today, U.S. Senator Elizabeth Warren (D-Mass.) and Representative Lloyd Doggett (D-Texas) sent a letter to Secretary of the Department of Commerce, Gina Raimondo, and Under Secretary Laurie Locascio, highlighting the lawmakers’ new review of public comments on the agency’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and urging them to strengthen and finalize the guidance. The proposal would help boost competition and reduce prices for American families by allowing the federal government to step in when private actors, including drug manufacturers, charge exorbitant prices for products that taxpayers helped pay to develop.

Specifically, the lawmakers call attention to an analysis revealing widespread public support for the National Institute of Standards and Technology’s draft guidance, with nearly 85% of the more than 50,000 comments – including individuals from all 50 states – expressing support for the proposal. 

“Our review of the comments indicates that the exercise of march-in rights has received broad support from seniors, from dozens of health care providers, and from the broader public,” wrote the lawmakers. “More than 85 percent of comments were in favor of the proposal, and these comments reveal that this is a popular framework that will help reduce exorbitant drug costs.”

In comments supporting the proposal, health care providers discussed the impact of high drug costs on patients, and older adults repeatedly raised their struggle to afford medications, often having to make difficult decisions about how to spend limited resources.

“NIST should finalize this framework to ensure that taxpayer-funded inventions are accessible and affordable to the public,” wrote the lawmakers. “Doing so would send a clear message that government is on the side of the American people, who underwrite these important discoveries—not Big Pharma.”

“Although big pharmaceutical companies are fighting this common-sense framework, there is a consensus among seniors, health care providers, and the general public: price must be a factor in agencies’ considerations for the use of march-in rights,” concluded the lawmakers. “We urge you to strengthen and finalize the guidance without delay to ensure that American taxpayers and consumers are able to access taxpayer-funded inventions at affordable prices.”

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

  • 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 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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