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.