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2024 Open Letter On Life Sciences Policy

An Open Letter to Members of Congress and the Biden Administration from Leaders in the Life Sciences Community As leaders...

 

An Open Letter to Members of Congress and the Biden Administration from Leaders in the Life Sciences Community


As leaders in the early-stage life sciences ecosystem, we write to you to restate our commitment to improving lives through biopharmaceutical advancements. The reputation of the American life sciences industry as a beacon of innovation, leadership, and hope has been well earned over the past 40 years, due in no small part to a public policy environment that created an ideal balance of scientific excellence, patient safety, entrepreneurial zeal, and risk-taking capital.


Nonetheless, as many of us gather in San Francisco at our industry’s premier annual conference, we are concerned that policy may become a barrier to what’s possible in the lab. While we commend the recent introduction of H.R. 7174, the Ensuring Protection for Innovative Cures Act (EPIC) Act, concerns remain regarding the Inflation Reduction Act’s drug pricing provisions; the multi-pronged assault on intellectual property protections; and popular misconceptions about acquisitions within our industry.


With regard to the EPIC Act, we ask you to consider joining Representatives Don Davis, Brett Guthrie, and Greg Murphy in supporting the development of new small molecule medicines. The bipartisan legislation presents a common-sense solution to a significant innovation impediment written in the Inflation Reduction Act of 2022, the small molecule penalty. The penalty forces investors to choose between a thirteen-year return verses a nine-year return, effectively shifting investment away from small molecule medicines and hindering the availability of future drugs. By aligning the price-setting timeline for small and large molecule medicines, so both receive 13 years, the EPIC Act strikes the small molecule penalty from federal law. Supporting the EPIC Act would solidify your dedication to protecting patients and progressing American ingenuity.


Though the EPIC Act is a step in the right direction, the IRA still presents a number of challenges for the life sciences. While it appropriately exempts certain orphan drugs from the Medicare negotiation program, these drugs will lose their exemption if they obtain more than one orphan designation. At a time when more than 90% of rare diseases do not have an FDA approved treatment, we must ensure that further research to develop a rare disease drug for additional rare diseases is enabled, not deterred—as such, we urge you to redefine the exemption so that this research can continue to flourish.


With respect to intellectual property (IP) protections, we are gravely concerned with the recent announcement that would allow the federal government to “march in” and order additional licensing of patents on products whose prices officials deem to be too high. The December 2023 notice by the National Institute of Standards and Technology (NIST) at the Department of Commerce breaks with decades of bipartisan precedent that IP protections will not be used as a political tool. Even the specter of government authority to seize IP for products sold at prices it doesn’t like will drive away much-needed investment.


But IP threats are not limited by our own borders. The NIST guidance follows a reversal of longstanding support for IP at the World Trade Organization. The support of the United States for the “TRIPS Waiver” was a signal that our commitment to IP had changed. A proposal to expand that waiver is still under consideration despite drawing bipartisan rebuke in Congress. Make no mistake, weakening IP protections will, in turn, weaken our industry and our global leadership in developing medicines.


Finally, we hope this letter will serve to clear up common misconceptions about the role of integration between life sciences companies. More so than in many industries, specialization of labor and effective capital deployment are critical to advancing through the different stages of clinical development: from academic institutions for asset discovery, to small biotechs for early human testing, then to larger pharmaceutical companies for pivotal clinical studies and to commercialize an approved drug. Efforts by the Federal Trade Commission and other agencies to prevent the acquisition of small biotech and biopharmaceutical companies by larger ones misconstrue these functions. Integration enables a drug to advance from the lab to the patient.


Patients should be the primary focus of public policy as it relates to healthcare. As a nation, we have long prioritized more development of safe and effective new medications to give patients and their families options and hope for the future—a goal that has been supported by appropriate drug development incentives, strong and stable IP protections, and a healthy integration environment to achieve the best results.


This is why thousands of scientists, entrepreneurs and investors flock to U.S.-based conferences throughout the year to discuss the next generation of medicines. Thanks to the right policies and support for this industry over the last four decades, the American life sciences ecosystem has led the global fight against the scourge of AIDS, hepatitis C, chronic conditions, myriad cancers and, most recently, COVID-19. But we still have a long way to go if we want to end cancer as we know it, turn the tide against the devastation of Alzheimer’s disease, or guard against future public health threats.


While we are optimistic about the next breakthroughs—some just at our fingertips—we must secure the public policy environment that will allow us to achieve them. We look forward to working with you to do so.



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