August 29, 2023

Senator Warren, Representative Jayapal Urge FDA to Hold Big Pharma Accountable for Abuse of Patent System, Profiteering at Patients’ Expense

 “The (FDA) should close loopholes in the patent system that pharmaceutical companies have exploited to rake in billions in profits.”

Text of Letter (PDF)

Washington, D.C. – U.S. Senator Elizabeth Warren (D-Mass.) and Representative Pramila Jayapal (D-Wash.) sent a letter to Dr. Robert M. Califf, Commissioner of the Food and Drug Administration (FDA), urging him to close loopholes that pharmaceutical companies have exploited to block generics from entering the market, keeping drug prices high and maximizing profits. The letter recommends four specific actions that FDA should take to use its existing authority to address anti-competitive pharmaceutical practices and make prescription drugs more affordable for patients. 

Presently, the FDA requires brand-name drug companies to submit patent information that covers drug substances, drug products, and methods of use. After approval, the FDA publishes this patent information in the Orange Book, which contains a complete list of FDA-approved drug and related patent and exclusivity information. Competing drug companies can review this information to determine whether they will seek FDA approval for a generic drug they want to market. 

“The pharmaceutical patents in the Orange Book are considered some of the ‘most valuable patents in the world,’ but about 25 percent of active patents in the Orange Book have been invalidated in court,” wrote Senator Warren and Representative Jayapal.

Big Pharma routinely adds improper patents to the Orange Book to block the introduction of lower-cost generics. Because the FDA will automatically delay review of a generic drug for 2.5 years if a  brand-name drug company sues that competitor for infringing on an Orange Book-listed patent, Big Pharma companies have an incentive to strategically list “sham” patents in the Orange Book to block generic competition, preserve  monopoly profits, and keep prices high. 

“The FDA has acknowledged these Orange Book-related problems to Congress and to the public,” wrote the lawmakers.  “The agency, with the U.S. Patent and Trademark Office (USPTO), also has announced initiatives to help ensure the patent system ‘is not used to improperly delay getting more affordable generic drugs and biosimilars into the hands of Americans who need them,’ and has sought public comments on the matter.  We support these collaborative efforts.”

To ensure competition in the pharmaceutical industry and lower the price of prescription drugs, Senator Warren and Representative Jayapal are recommending that the FDA consider:

  • Clarifying guidelines for patents that can be listed in the Orange Book; 
  • Working closely with the USPTO to develop a review and validation system for every patent that is listed in the Orange Book; 
  • Revising policies regarding FDA “suitability petitions;” and 
  • Sharing information provided by drug manufacturers in applications for Investigational New Drugs with USPTO.

Senator Warren has led efforts to use every tool available to the government to lower drug prices and fight Big Pharma’s anti-competitive business practices: 

  • In June 2023, Senators Warren 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 April 2023, Senator Warren and Representative Jayapal sent a letter to Kathi Vidal, Director of the 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. The lawmakers outlined six specific actions that the USPTO should take. 
  • 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 Secretary Xavier Becerra that urged the Secretary to exercise his authority to lower the price of cancer treatment 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 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 HHS 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.).