Opinion by Greer Donley and Rachel Sachs: Antiabortion-pill suit imperils drug development and access broadly
involving many steps that the FDA must comply with before it can remove products from the market. This reassures the pharmaceutical industry that its approved products cannot be removed without serious, well-documented concerns about safety or efficacy. When the FDA does attempt to remove a fully approved product from the market, the manufacturer typically complies voluntarily.
The pharmaceutical industry has grownCompanies who have learned to navigate FDA requirements could no longer rely on one, predictable regulator but would be subject to conflicting judgments from around the country. Indeed, the industry has argued in favor of regulatory harmonization globally to ensure that the trials they conduct to demonstrate safety and efficacy are accepted by a broad range of national regulators, not just one.
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