June 09, 2023

Senators Warren, King and Representative Doggett Seek Answers from HHS and Commerce on Interagency Working Group for Bayh-Dole

Lawmakers Urged the Agencies to Move Swiftly to Lower Drug Prices 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) sent a letter to Department of Commerce (DOC) 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 March of this year, on the same day that the National Institutes of Health (NIH) rejected a petition to march-in on the prostate cancer treatment drug Xtandi, HHS and DOC announced the formation of an interagency working group to develop a framework for implementation of the march-in provision of the Bayh-Dole Act.

“We are pleased that the Working Group will consider price in its evaluation of the Administration’s march-in authority, but we are concerned that there have been no public updates about the Working Group’s membership, process, timeline, or scope of work in the more than two months since it was first announced,” wrote the lawmakers. 

The passage of the Inflation Reduction Act last year included critical drug pricing reforms aimed at helping older adults afford life-saving medications by empowering Medicare to directly negotiate some drug prices, limit price spikes, and cap out-of-pocket costs. 

“Though this represents critical progress, more must be done to curb excessive drug prices, including for the more than 200 million Americans who are not on Medicare,” wrote the lawmakers. “The Biden Administration can use its existing authority to step in on behalf of all Americans and rectify pharmaceutical industry abuses that have allowed drug prices to skyrocket, and it can do so without waiting for permission from Congress.”

The lawmakers are asking that DOC and HHS consider including whether a drug is priced higher in the United States than in other high-income countries in the definition of “reasonable terms” under the statute; explore royalty-free rights in addition to march-in rights; provide a list of drugs developed with taxpayer funds and related patents; ensure officials involved with the Working Group are free from conflicts of interest; commit to transparency during proceedings and balanced stakeholder participation, and publish the final framework by December 31, 2023. 

“We support President Biden’s goal of lowering drug prices for Americans, and if adopted, we believe these principles will allow the Working Group to fully and independently study these authorities,” concluded the lawmakers.

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

  • In April 2023, Senator Warren and Representative Pramila Jayapal (D-Wash.) 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 Angus King (I-Maine) and Representative Lloyd Doggett (D-Texas) led their colleagues in sending a follow-up letter to Health and Human Services (HHS) Secretary Xavier Becerra that urged the Secretary to exercise his authority to lower the price of cancer treatment drug Xtandi. 
  • In December 2022, Senator Warren and Rep. 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 Angus King (I-Maine) and Representatives Lloyd Doggett (D-Texas), Joaquin Castro (D-Texas), Sara Jacobs (D-Calif.), and Katie Porter (D-Calif.), led a group of 100 members from across the ideological spectrum to urge Health and Human Services (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.
  • Senator Warren has also introduced legislation that would radically reduce drug prices through public manufacturing of prescription drugs, including the Affordable Drug Manufacturing Act with Representative Jan Schakowsky (D-Ill.).