Generic drugs face quality, safety questions
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The Food and Drug Administration has approved a record number of generic drugs, but at the same time it’s inspecting a lot fewer of the factories where those drugs are made.
Why it matters: Declining inspections are raising new concerns about their quality and safety, Bloomberg’s Anna Edney reports in the first part of a yearlong investigation.
- And in addition to a drop in overall inspections, the FDA has in some cases been slow to crack down on the problems it does find, Edney reports.
By the numbers: Generics make up roughly 90% of all U.S. prescriptions.
- FDA inspections of facilities inside the U.S. fell by 11% from 2017 to 2018 and have been falling since 2011, when the agency began shifting more resources overseas.
- But international inspections, after rising steadily for years, have also been on the decline since 2016.
- Companies from India and China alone account for almost half of all new generic drugs, and more than 80% of drugs' active ingredients are made abroad.
Between the lines: The story also includes 2 anecdotes in which FDA inspectors uncovered violations and began work on enforcement letters, but "higher-ups at the FDA … overrode the concerns of those on the ground."
The other side: "It’s not the number of inspections we do, it's whether we're targeting effectively," FDA Commissioner Scott Gottlieb told Bloomberg.
- Janet Woodcock, who leads the agency’s center for drug reviews, also said the agency’s oversight is "better than it's ever been."