Representative Doggett and Senator Warren Urge Biden Administration to Lower Prices for Prescription Drugs

"Rampant price gouging has resulted in nearly one-third of Americans rationing or skipping necessary medications."

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Washington, D.C.-Before Donald Trump assumes the White House and a Republican-led Congress attempts to obstruct progress on reigning in pharmaceutical companies, Representative Lloyd Doggett (D-Texas) and Senator Elizabeth Warren (D-Mass.) are urging the Biden Administration to fulfill its promise and finalize a strengthened framework to lower prescription drug prices and ensure increased transparency, oversight and accessibility of taxpayer-funded medical products. Specifically, the lawmakers ask Commerce Secretary Gina Raimondo and Health and Human Services Secretary Xavier Becerra to release the "Interagency Guidance Framework for Considering the Exercise of March-In Rights" by the end of the year.

The members write, "It is long past time for the Working Group to finalize a strengthened Framework that protects taxpayers' interests and ensures that the inventions whose development they helped finance are affordable and accessible. This would probably be the most meaningful step which the Biden Administration could undertake during these last two months to show an understanding of the economic concerns of American families. Further delay with an unwillingness to finalize the Framework only harms public health and safety."

As Americans continue to face the burden of high medication costs, the Inflation Reduction Act has made some modest strides in lowering prices, but its impact remains limited for most consumers. Meanwhile, taxpayers contribute around $115 billion annually to fund research and development yet lack any assurance that the resulting innovations will be priced fairly or that they will benefit from it. The Bayh-Dole Act permits government agencies to license generic versions of taxpayer-funded inventions, such as crucial cancer treatments, in certain situations, particularly when there is a public health or safety need. The Biden Administration's Interagency Working Group on Bayh-Dole introduced draft guidelines last December to help agencies determine when to exercise this authority, including in cases where a product is priced excessively. However, in almost a year since, agencies have not received a final framework.

The full letter can be found hereand below.

Dear Secretary Raimondo and Secretary Becerra,

Nearly a year has passed since you released the Interagency Working Group for Bayh-Dole's Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights ("the Framework") for public comment, which concluded almost ten months ago. It is long past time for the Working Group to finalize a strengthened Framework that protects taxpayers' interests and ensures that the inventions whose development they helped finance are affordable and accessible. This would probably be the most meaningful step which the Biden Administration could undertake during these last two months to show an understanding of the economic concerns of American families. Further delay with an unwillingness to finalize the Framework only harms public health and safety. Rampant price gouging has resulted in nearly one-third of Americans rationing or skipping necessary medications.

U.S. taxpayers invest over $54 billion annually in biomedical research to help fund the development of every new drug approved over a decade. Yet, they continue to be charged unreasonable prices that far exceed what consumers in other wealthy nations pay. For example, the cancer treatment Yescarta was developed with at least $10 million of direct taxpayer funding and at least $200 million of taxpayer-funded foundational research. As disclosed by the manufacturer, "All of the preclinical and clinical trials relating to our product candidates have to date been conducted by the NCI [National Cancer Institute]." Despite the manufacturer describing the process as "highly dependent on the National Cancer Institute for research and development," the treatment costs Americans $424,000 per year- more than any other wealthy nation. In 2022, the manufacturer made more selling Yescarta in the U.S. than the rest of the world combined.

Taxpayers and consumers cannot afford further delay in action. Failure to address the unaffordability of Xtandi-a prostate cancer drug developed with taxpayer funds yet costing Americans up to six times what other consumers pay-has cost Medicare billions of dollars each year. In the approximately two years between a march-in petition being filed and a subsequent appeal, Medicare spent almost $5 billion. If the drug had cost even one-third of its price, Medicare would have saved more than $3.3 billion while that petition languished.

We understand that strengthening and finalizing the Working Group's Framework is not necessary for an agency to act, but the failure to finalize the Framework serves as a disincentive and a signal that this Administration does not intend to fulfill its responsibility to protect taxpayers. To ensure every agency understands its obligation to evaluate the affordability and accessibility of federally-funded inventions, we strongly urge you to strengthen and finalize the framework before the end of this year.

Issues:Healthcare