Judge Matthew Kacsmaryk of the Northern District of Texas ruled in April to suspend the Food and Drug Administration’s (FDA) approval of mifepristone, an abortion pill that has been used safely and effectively for more than 20 years. This decision, if upheld by the Supreme Court next week, could have enormous repercussions for the future of scientific research.
As of now, an appeals court has said mifepristone can remain available, with some restrictions, but the dangers of such a decision regarding the future of regulatory processes could be catastrophic. A group of bio/pharma executives who issued the subsequent letter of protest were right to express their outright consternation. (Full disclosure: The New York Academy of Sciences, where I am president and CEO, receives funding from pharmaceutical programs.)
Without getting into the politics of why this particular ruling was made, a judge with no scientific or medical training overturning an approval made by a federal regulatory agency — based on years of scientific data and trials — has the potential to work its way into the labs where such research is conducted.
Like many other industries, the bio/pharma business relies heavily on partnerships with the academic and research sector. These institutions often conduct the essential foundational studies that yield the extraordinary wealth of medical advancements that have improved lives for billions of people throughout the world.
We saw this happen with the decision made by the Bush administration in 2001 banning the use of federal funding for research on human embryonic stem cell lines. While Bush’s decision had some minor exceptions, it nonetheless had a serious impact on several areas of crucial research on conditions such as Parkinson’s Disease, which affects an estimated 10 million people worldwide.
Moreover, the decision also drove American researchers to seek out research hubs outside of the country. Singapore provided a research-friendly environment that put the country on the map as a center for biotech development.
The ban was later revoked through an executive order by President Obama — a move widely applauded by the scientific community worldwide — but the damage had been done and, with years of invaluable data going uncollected, research on stem cells was set back nearly a decade.
The issue is also an economic one. More than 5 million people worldwide are estimated to work in the pharmaceutical industry. Of those, an estimated 314,000 are employed in U.S. research and development (R&D) alone. The biopharmaceutical industry has the largest number of R&D workers of any American industry. These are typically well-paying jobs that allow people to purchase homes, cars and contribute the tax dollars that sustain thriving economies, both nationally and internationally.
Going beyond this point, looking at the current Bureau of Labor Statistics job growth fields, the highest rates of growth are in fields where STEM (science, technology, engineering and mathematics) skills are in high demand. Will young people even want to study in the STEM fields if they feel that an individual judge with a particular political agenda can make a decision — not supported by any substantive evidence — that can impact entire sectors of the global economy?
It is encouraging that in light of Kacsmaryk’s ruling, the voice of the scientific community is being raised and supported by business leaders. But more needs to be done — policymakers and legislators need to weigh in.
Allowing non-scientists to decide which FDA approved medications may or may not be used — by default, allowing them to decide the future of medical research — will negatively affect research globally. If we want to ensure a thriving, sustainable global research sector now and in the future, it’s imperative that scientific research, and its resulting breakthroughs, remain above political agendas.
Nicholas B. Dirks is president and CEO of The New York Academy of Sciences. Previously, he served as chancellor of the University of California, Berkeley and executive vice president and dean of the Faculty for Arts and Sciences at Columbia University. He is the author of eight books, including the forthcoming “City of Intellect: The Uses and Abuses of the University.” Follow him @nickdirks.