Pharmaceutical industry group Pharmaceutical Research and Manufacturers of America insist that the Federal Food, Drug and Cosmetic Act outlines a “rigorous and thorough” drug approval process. They caution that allowing the Fifth Circuit’s ruling to stand could have catastrophic consequences, wreaking havoc in the pharmaceutical world and stymying innovation.
The Integrity of Science-Based Determinations at Stake
Congress members raise a poignant concern: “The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated.” They underscore that researchers, healthcare providers, and patients rely on the integrity of a science-based drug approval process, and judicial interference threatens access to life-improving and life-saving drugs.
Abortion Pill Battle : Specific Grievances Emerge
Moreover, certain groups take issue with particular elements of the Fifth Circuit panel’s decision. Nurse practitioner and physician associate organizations, for instance, call for a reversal, as the decision eliminates an FDA rule permitting advanced practice clinicians and other qualified practitioners to prescribe mifepristone, thus limiting women’s healthcare access.
