Washington, DC — Today, Former Deputy FDA Commissioner and HHS General Counsel Williams Schultz and Dean of GWU’s Milken Institute School of Public Health Lynn Goldman joined Supreme Court and appellate lawyer Andy Pincus and Protect Our Care to discuss the disastrous implications of Judge Matthew Kacsmaryk’s ruling to invalidate the FDA’s approval of mifepristone. During the event, speakers discussed how Judge Kacysmaryk’s ruling has wider implications for the health care system and sets a precedent for any judge to be able to overrule the evidence-based and scientific FDA medication approval process. Read Protect Our Care’s new report on the case here.
“In this case where the drug has been in use for decades, the harm to tens if not hundreds of thousands of women from removing its availability would be very significant,” said Andrew Pincus, Visiting Lecturer in Law at Yale Law School and experienced Supreme Court and appellate lawyer. “If this decision stands, then any group of doctors who are opposed to a particular drug or vaccine could bring a similar lawsuit, and that will really open the door to very broad instability in the drug approval process.”
“Congress in the statute directed the FDA to evaluate the safety and effectiveness of drugs to determine whether the benefits of the drug outweigh the risks. This is a complex decision involving medicine, statistics, and sometimes epidemiology,” said William Schultz, Partner, Zuckerman Spaeder, former Deputy Commissioner, FDA, former General Counsel, Department of Health and Human Services. “If the decision were upheld, it could have a devastating effect on drug and vaccine development in this country. It would mean that in order to get a drug approved, companies will not just have to survive hundreds of millions of dollars and years of testing and FDA scientific review, but then they’ll have to survive challenges in court, which could be immediate, or as in this case, 20 years later.”
“For doctors or patients and their families, it is critically important that we can trust the basis for the approval of a drug,” said Lynn R Goldman, MD, MS, MPH, Professor and Dean, Milken Institute School of Public Health, George Washington University. “There are reams of data that underlie every drug approval process and a multitude of decisions that must be made. For us to trust the consequences of that review, they need to be made by scientific experts who understand those data and can best evaluate them — and those experts are not judges and they’re not courts of law.”
“Judge Kacysmaryk’s ruling threatens to throw the entire U.S. drug approval process into chaos,” said Protect Our Care Chair Leslie Dach. “It not only puts at risk the use of mifepristone for safe and legal abortions, but it opens the door for the politically-motivated removal of other safe and effective drugs from the market. If the ruling stands, millions of patients will suffer.”