“…As a result of a joint public-private partnership, Xtandi costs proportionately less than 0.023% of the overall development cost to taxpayers, hundreds of thousands of patients who otherwise would not exist. I received life-saving treatment.” – GIPC Letter to Senators Sanders and Cassidy
On March 22nd, the US Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter to Senators Bernie Sanders (I-VT) and Senators Bill Cassidy (R-Los Angeles). Health, Education, Work, and Pensions regarding the same-day Health Commission hearing on pricing of Moderna’s COVID-19 vaccine. The GIPC letter seeks to push back on misrepresentations about the role of public funding in private drug research and development (R&D), and also doubles down on the Center’s criticism of drug pricing controls under the recently enacted Inflation Reduction Act. I was allowed to.
NIH ruling denying march-in rights to Xtandi affects hearing in Moderna vaccine
The Senate Health Committee hearing was entitled “Taxpayers Paid Billions For It: So Why Should Moderna Consider Quadrupling The Price Of The COVID Vaccine?” Moderna CEO Stephan Bancel said the COVID-19 vaccine will start at $26 and go up to $130. Commission members, especially Democrats, are expected to threaten Moderna that the government may exercise its right to march under the Bayh-Dole Act to prevent Moderna from raising consumer prices for vaccines. I was.
But the hearings came shortly after the National Institutes of Health (NIH) ruled to deny its right to march under the Bayh-Dole Act to set consumer prices for the prostate cancer drug Xtandi. That decision was subsequently appealed by a series of petitioners to U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra, and recently both HHS and the U.S. Department of Commerce have considered potential marching rights under Bye. announced. -Doll.
As GIPC letters to Sanders and Cassidy show, the Center’s concerns focus on the potential for false narratives to influence policy decisions and “upend successful legal frameworks that foster public-private partnerships and commercialization.” is guessing. Throughout the letter, the GIPC raises arguments similar to those in the recent 2023 Patient Access Report to demonstrate not only the negative impact of price controls on patient access, but also the question of how public taxpayer funding should affect patients. It also demonstrates a significant amount of private investment in drug development that belies the claim that The federal government has the right to interfere in private license negotiations.
Policy makers must not want innovative medicines cut and waiting times longer
The “failed premise” that government intervention can improve patients’ access to life-saving treatment is already embodied in the Inflation Reduction Act (IRA), GIPC said. In tracking the impact of similar price controls in other countries, the 2023 Patient Access Report concluded that the IRA’s drug pricing rules will make fewer new treatments available to US patients. The GIPC’s letter to Senators Sanders and Cassidy said, “Certainly, this result of fewer innovative medicines and longer waiting times is not what policy makers and advocates want.” claims.
Not only are private companies funding more drug development in absolute terms, they also support the pharmaceutical sector’s R&D spending at a much higher rate than the federal government. The GIPC, citing the 2019 Congressional Budget Office (CBO) Report on Private Expenditures on Drug R&D Spending, reported private investment of $83 billion, a total of $83 billion in drug development compared to a similar amount in drug development in the 1980s. 10 times more than private spending. In addition, looking at public and private investment in 18 market-approved treatments funded by NIH grants, totaling $670 million, public sector funding reached $44.3 billion. Private investment in the same treatment is dwarfed.
Public taxpayers contributed only 0.023% of Xtandi’s R&D costs
The disparity in public and private R&D spending in the pharmaceutical industry is striking in the case of Xtandi, which is at the center of the Bayh-Dole lawsuit recently appealed by the NIH.
“UCLA, the patentee, received less than $500,000 in funding from taxpayers to support the early-stage research that directly contributed to the original discovery of Xtandi. In contrast, Astellas and its partners has contributed approximately $2.2 billion to preclinical research and clinical trials to bring Xtandi to market, a contribution of this joint public-private partnership to taxpayers at less than 0.023% of Xtandi’s overall development costs. As a result, hundreds of thousands of patients received life-saving treatments that otherwise would not have existed.”
March-in rights under the Bayh-Dole Act are intended to be restricted, argued by the GIPC, and do not serve as a price control mechanism by which the U.S. federal government can revoke exclusive patent licenses between private entities. The conclusion is the statements of Senators Birch Bye and Robert Dole, who gave the 1980 law its name, and current Senators Tom Tillis (R-North Carolina) and Marsha Blackburn, who passed Becerra last February. It was reinforced by both letters addressed to the Commissioner. (Republican-Tennessee) recognizes that the use of march-in rights to control drug prices is contrary to the very purpose of the law.
“The Bayh-Dole Act works well and provides countless benefits to the American people,” a GIPC letter told Senate Health Committee leaders. Although it has enabled a technology transfer system that companies can commercialize, and that system has benefited consumers in many industries, the GIPC will not specifically support the life sciences and biopharmaceutical sectors under the legal framework of this Act. He points out that he is thriving. Before the law was passed, zero drugs were commercialized from publicly funded research and development, but since the law was passed, there have been a number of cancer treatments, including several blockbuster treatments that have saved lives. More than 200 such products have been commercialized.The GIPC letter told Senate Health Committee leaders that all available evidence bears the brunt of the enormous costs and risks in drug development. and that such private entities operate under the current legal framework without the threat of government price controls. should be allowed.
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Author: Auriso
