FDA Leadership’s “Blind Spots” Lead to a Surge in Medical Device and Drug Recalls
FDA Leadership’s “Blind Spots” Lead to a Surge in Medical Device and Drug Recalls by David Gortler, Pharm. D at Brownstone Institute Americans assume that when they pick up a prescription from their pharmacy, an FDA quality control professional has verified that the contents are manufactured to rigorous agency standards. Unfortunately, that assumption is becoming harder to defend. For decades, the FDA’s drug oversight model has depended on in-person inspections of the manufacturing practice and independent verification of product quality. While no regulatory system is perfect, the underlying…
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