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Tuesday, November 5, 2024

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

Lloyd doggett

Lloyd Doggett | Official U.S. House headshot

Lloyd Doggett | Official U.S. House headshot

Washington, D.C. – U.S. Representative Lloyd Doggett (D-Austin) andSenators Elizabeth Warren (D-Mass.) and Angus King (I-Maine) 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.

Read the full letter here.

Original source can be found here.

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