April 25, 2022

Warren Urges Biden Administration to Lower Prescription Drug Prices Using Existing Executive Authority

Over 25 Legal and Public Health Experts Confirm Administration’s Legal Authority to Act

Letter to Secretary Becerra (PDF)
Letter to Senator Warren from Over 25 Legal and Public Health Experts (PDF)

Washington, D.C. – United States Senator Elizabeth Warren (D-Mass.) sent a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, sharing the findings from a letter that over 25 legal and public health experts sent to her, which outlines three powerful legal tools that the Biden administration can use to lower drug prices for consumers. Senator Warren is urging Secretary Becerra and the Biden administration to use its existing legal authority to swiftly lower drug prices and provide relief to millions of American consumers who are paying too much for their prescription drugs. 

“High prescription drug prices in the United States are a major problem today for both patients and the sustainability of our healthcare system… Existing law gives the executive branch several tools to intervene when patients and public health are harmed by excessive drug prices. These tools can help the Administration break patent barriers, foster competition where currently there is none, and drive down prices. Critically, using them requires no additional congressional action,” wrote the legal and public health experts. 

The letter sent to Senator Warren was signed by over 25 legal and public health experts, led by Professor Amy Kapczynski at Yale Law School, Dr. Aaron S. Kesselheim at Harvard Medical School, and Dr. Christopher J. Morten at Columbia Law School. The experts describe three legal tools that the Biden administration can use to obtain fair prices for prescription drugs, without the need for any congressional action: the “government patent power” codified at 28 U.S.C. § 1498 and the Bayh-Dole Act’s “royalty free-license” and “march-in rights.” In the letter, the experts confirm that these three tools are “integral, longstanding, and legitimate parts of our patent system,” explaining that “§ 1498 is a powerful general-purpose tool to target excessive pricing, while the Bayh-Dole Act is particularly helpful for patents that received government research support.” They conclude by calling on the Biden administration to “devote attention to using these tools to address the ongoing crisis in drug prices.”

Senator Warren has called on the Biden administration to use every tool to lower drug prices and crack down on corporate profiteering to bring down consumer costs:

  • On February 17, 2022, Senators Warren and Angus King (I-Maine), and Representative Lloyd Doggett (D-Texas) urged HHS to exercise march-in rights for life-saving cancer drug Xtandi to dramatically lower its price for millions of Americans.
  • On February 2, 2022, during a hearing of the Senate Finance Subcommittee on Fiscal Responsibility and Economic Growth, Senator Warren called out Big Pharma and insurance companies’ tricks to squeeze taxpayers and Medicare beneficiaries. She also called for passage of the Build Back Better Act, which includes provisions that could generate billions in savings and give HHS the authority to negotiate prices on some high-price drugs.
  • On July 28, 2021, Senators Warren and Amy Klobuchar (D-Minn.), and Representative Doggett asked Secretary Becerra for an update on HHS’s plans to use its executive authorities—including Section 1498 and march-in rights—to lower drug prices.
  • 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.
  • At a Senate Finance Committee hearing in May 2021, Senator Warren called for trade negotiations that put patients over Big Pharma profits
  • 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.). With Senator Jean Shaheen (D-N.H.), she introduced the End Taxpayer Subsidies for Drug Ads Act, legislation that would close a Big Pharma advertising loophole