Guest columnist Lawrence Pareles: Lawsuit not about mifepristone – It’s about the FDA and safety of our medicines

By LAWRENCE PARELES

Published: 07-18-2023 8:20 PM

I am writing to express my deep concern about a recent legal case that challenges the legitimacy of the U.S. Food and Drug Administration. This case poses a significant threat to the integrity of our drug approval process and should be addressed urgently.

In April, a federal court in Texas made an unprecedented decision to invalidate the FDA’s approval of mifepristone, a safe and effective drug that’s been used for more than 20 years. Mifepristone, a progesterone blocker with multiple uses (including terminating pregnancies and managing miscarriages) was deemed unsafe by one judge’s ruling. This decision is not only contradictory to extensive scientific evidence, but also ignores the fact that mifepristone is safer than many widely used medications such as Tylenol and Viagra.

The Alliance for Hippocratic Medicine v. US FDA case challenges the FDA’s expert judgment in approving mifepristone, despite its thorough evaluation of its safety and effectiveness. Mifepristone was approved by the FDA in 2000 after rigorous scrutiny and extensive clinical trials. The drug plays a crucial role in reproductive health care, giving women a safe and effective option for terminating early pregnancies.

The FDA’s approval process is designed to safeguard public health by subjecting medications to rigorous scientific evaluation and stringent standards. The lawsuit against mifepristone not only undermines these well-established processes but also erodes trust and confidence in the FDA’s decision-making abilities.

If the approval of mifepristone can be retroactively blocked by a court, it sets a dangerous precedent by allowing legal challenges to the safety of other long-approved medications, too.

Allowing a federal judge to second-guess the independent judgment of the FDA’s scientists and politicize the drug approval process poses grave consequences. It opens the floodgates for anyone to challenge any approved drug at any time, leading to massive uncertainty for drug manufacturers, which would destabilize the entire drug market. This would lead to higher drug costs and could compromise access to essential medicines.

It is crucial that policymakers, health care professionals, and concerned citizens unite in voicing their opposition to this misguided legal case and support the FDA’s commitment to evidence-based medicine. Preserving the integrity of the FDA approval process is essential to ensure public safety and maintain trust in this regulatory agency.

I commend the Biden administration for vigorously defending the legitimacy and political independence of the FDA. Although mifepristone is still available during the federal court appeal process, we can anticipate the case being reviewed by the very conservative Supreme Court.

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I urge all our elected representatives to strongly support the FDA in its mission to ensure the safety and efficacy of our medicines and protect public health. We must act decisively to counter this threat to our well-proven drug approval process. Together, we can ensure that evidence-based medicine remains the cornerstone of our modern health care system.

Thank you for your attention to this very real problem.

Lawrence Pareles lives in Florence.

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