“These efforts are a mistake, and are not consistent with the Chamber’s stated goal of ‘expand(ing) access to and improv(ing) the affordability of high-quality health care services for all Americans.’ If successful, they will undermine the Biden Administration’s effort to reduce drug prices and insurance premiums, hurting consumers and small and large businesses.”
Washington, D.C. – Senator Elizabeth Warren (D-Mass.), Bernie Sanders (I-Vt.), and Jeff Merkley (D-Ore.) wrote to the Chamber of Commerce (Chamber) expressing concern and demanding an explanation for the organization’s opposition to the Biden Administration’s proposal to boost competition and lower drug prices for American families and businesses by allowing agencies to consider price when deciding to exercise their “march-in rights” under the Bayh-Dole Act.
Under the Bayh-Dole Act, the federal government has the ability to step in and re-license patents on drugs and other inventions that were developed using federal funds when they are not “available to the public on reasonable terms.” The Biden Administration’s proposal would help the vast majority of the Chamber’s members – from big businesses to small entrepreneurs, all of which, as employers, face higher health insurance costs when Big Pharma overcharges for prescription drugs.
“Big Pharma has waged a decades-long war against the law to protect their enormous profits…(The proposal) clarifies that taxpayers have a backstop when drug manufacturers charge extortionate prices for drugs that were developed with public funds,” wrote the lawmakers.
Instead of working to support the thousands of members who stand to benefit from efforts to end drug company profiteering, the Chamber launched the Business Alliance to Stop Innovation Confiscation (BASIC) Coalition, to “stymie the White House’s drug pricing initiatives.” According to reports, this coalition will be “backed by a seven-figure campaign that will include research, polling and digital, grassroots and traditional advocacy efforts.”
The federal government spends hundreds of billions of dollars to support basic science and pharmaceutical innovations, providing significant benefits to big pharmaceutical manufacturers. But these private drug manufacturers can then turn around and charge exorbitant prices for these publicly-funded products. For example, a course of treatment for Xtandi, a prostate cancer drug sold by Astellas that was developed with significant federal government support, can cost a U.S. consumer approximately $150,000 more than a consumer in Japan.
The lawmakers are demanding an explanation from the Chamber for its opposition to the proposal and asking a series of questions about the decision to create the BASIC coalition, the impact of march-in rights and reduced health care prices on their members and small businesses, and how the coalition’s budget will be spent.
Senator Warren has led the fight for affordable health care and fair practices in the health care industry:
- In March 2024, Senator Warren questioned Health & Human Services (HHS) Secretary Xavier Becerra on the Biden administration’s proposal to boost competition and lower prices on drugs that American taxpayers helped pay to develop.
- In February 2024, Senators Warren and King (I-Maine) and Representative Lloyd Doggett (D-Texas) 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 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 Warren and Representative 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 November 2023, Senators Warren and Braun (R-Ind.) sent a letter urging the Department of Health and Human Services (HHS) Inspector General to determine if vertically-integrated health care companies are hiking prescription drug costs and evading federal regulations.
- In August 2023, Senator Warren and Representative Jayapal (D-Wash.) 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 King (I-Maine), and Representative 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 (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 Sanders (I-Vt.) and Representatives Jayapal (D-Wash.) and 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 (I-Maine) 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 (D-Wash.) 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 (D-Texas), Castro (D-Texas), Jacobs (D-Calif.), and Porter (D-Calif.) 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.
- In December 2019, Senator Warren introduced legislation that would radically reduce drug prices through public manufacturing of prescription drugs, including the Affordable Drug Manufacturing Act with Congresswoman Schakowsky (D-Ill.).
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