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America’s biopharmaceutical companies share President Biden’s commitment to eradicating cancer. With more than 1,300 medicines in the research pipeline, the science has never been more promising.
But as industry research and development leaders warn in a new letter to the Biden Administration, the Cancer Moonshot might have to call off its mission before it can get off the ground. That’s because the administration is pursuing several misguided policies that impede the innovation needed to develop the next generation of treatments and cures.
Here are four key policy concerns that research and development leaders from PhRMA’s member companies laid out in a letter to Dr. Danielle Carnival, Deputy Assistant to the President for the Cancer Moonshot:
- The price setting provisions in the Inflation Reduction Act (IRA) will be particularly devastating for cancer patients. The law penalizes the development of small molecule medicines that typically come in pill or tablet form. These make up the majority of new cancer medicines. The government can select these medicines for price setting just seven years after coming to market. The leaders warn that because of this pill penalty, “some companies will shift focus away from researching and developing small molecule drugs targeting cancer," leaving patients without access to new, breakthrough treatments.
- Because government price setting can occur so soon after initial U.S. Food and Drug Administration (FDA) approval, new uses for existing medicines may never be developed. Some of the most promising clinical research for cancer medicines happens after a medicine is first approved. That’s when researchers often learn whether other patients — perhaps with different forms of cancer — may benefit from an already-approved treatment. Industry leaders warn the law is “threatening the continued investment and R&D necessary to evaluate the full therapeutic value of the medicine,” and is “cutting off hope” for those with cancer.
- The administration has taken steps to limit the availability of medicines granted accelerated approval by FDA. The accelerated approval pathway allows the FDA to expedite access to medicines that address serious unmet medical needs, while preserving the FDA’s gold standard for safety and effectiveness. With a majority of medicines receiving accelerated approval in oncology, R&D leaders warn recent steps from the administration are “sending a signal that scientists should abandon accelerated approval” and “could mean lifesaving medicines could take longer to reach patients.”
- The administration’s actions support eroding intellectual property (IP) protections. This includes agreeing to waive the protections that enabled COVID-19 vaccine development and threatening longstanding policies that foster collaboration between the public and private sectors. This puts the U.S. innovation ecosystem at risk. As R&D leaders write in their letter, “IP protections are the foundation upon which scientific research is built” and the administration’s actions “could further chill R&D and inhibit our ability to address a broad range of diseases, including cancer.”
We stand ready to partner with the administration to accomplish the mission laid out by the President’s Cancer Moonshot. But as the R&D leaders point out in their letter, the administration needs to “support policies that make the work by research scientists possible to deliver for patients and our society.”
Read the full letter here.
Stephen J. Ubl
Stephen J. Ubl is president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents America’s leading biopharmaceutical research companies. The U.S. biopharmaceutical sector directly employs more than 800,000 Americans and invests more than $100 billion in research and development annually – more than any other industry in America.
Ubl leads PhRMA’s work preserving and strengthening a health care and economic environment that encourages medical innovation, new drug discovery and access to life-saving medicines. Ubl is recognized around the world as a leading health care advocate and policy expert who collaborates successfully with diverse stakeholder groups – including patient and physician groups, regulators, public and private payers, and global trade organizations – to help ensure timely patient access to innovative treatments and cures. The New York Times writes, “If anyone can find areas of agreement with the critics, or at least work productively with them, it may be Mr. Ubl. He is more conversant with the intricacies of health policy, and more adept at the politics."
Previously, Ubl served as president and CEO of medical technology association AdvaMed, where he helped facilitate landmark reforms related to the U.S. Food and Drug Administration product review process and Medicare’s coverage and reimbursement of medical technologies. He led the industry’s defense of breakthrough R&D, successfully delaying an innovation-stifling device tax, and, in 2013, was recognized by a leading industry publication as one of 10 people to have a lasting impact on the medical technology industry.
Ubl has worked extensively with patient advocacy organizations in health policy, including longstanding service on the board of the National Health Council, a leading umbrella organization for voluntary health care organizations and has been personally involved with JDRF (formerly known as the Juvenile Diabetes Research Foundation).
He is routinely recognized as one of Washington’s most effective advocates. Ubl has been recognized on Business Insider’s “DC Healthcare Power Players” and Modern Healthcare’s “100 Most Influential People in Healthcare.” He is identified as a top health influencer by Medical Marketing & Media and PR Week magazines.
https://x.com/steveubl
https://www.linkedin.com/in/steveubl/
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