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February 7, 2019

FDA is ramping up generic drug approvals—but ramping down inspections. Is that safe?

Daily Briefing

    FDA is approving new generic drugs at record levels, but the agency is conducting fewer inspections of facilities that manufacturer those drugs, raising concerns over the quality and safety of FDA-approved generic products, according to a yearlong Bloomberg investigation.

    Learn 6 ways to fill the right order for pharmacy transformation

    About the investigation

    For the investigation, Bloomberg spent a year examining how FDA regulates the generic-drug industry. To do so, Bloomberg:

    • Reviewed more than 10 years of FDA inspection data and thousands of pages of pretrial depositions; and
    • Interviewed more than two dozen sources, including current and former FDA inspectors, agency officials, lawmakers, and industry experts.

    The Bloomberg investigation found as FDA's generic-drug approvals have increased over the past few years, FDA inspections have decreased.

    In particular, Bloomberg found FDA's generic drug approvals increased by 94%, from 500 generic drug approvals in fiscal year (FY) 2014 to 971 generic drug approvals in FY 2018.

    Meanwhile, FDA is conducting fewer global surveillance inspections, which are intended to ensure drug manufacturers meet U.S. standards, according to Bloomberg. The number of inspections for U.S. facilities have been falling since 2011, and those inspections fell by 11% from FY 2017 to FY 2018 alone. Bloomberg also found FDA's inspections of international facilities—which produce about 80% of the active ingredients used to produce U.S. drugs—fell by 10% from FY 2017 to FY 2018.

    In addition, Bloomberg found FDA is slow to take enforcement actions when FDA inspectors discover U.S. and international facilities are violating FDA regulations. In at least two instances, Bloomberg found FDA inspectors had begun writing enforcement letters to facilities found in violation of FDA regulations, but "higher-ups at the FDA … overrode the concerns."

    FDA officials say inspection numbers do not represent FDA oversight

    Sarah Peddicord, an FDA spokesperson, said, "FDA issues warning letters when it deems it necessary to take such action based on a combination of factors, including FDA inspectional findings, follow-up with companies and other factors." Peddicord said in one case involving Mylan, FDA inspectors identified problems that had "occurred in the development environment and was not associated with commercial product," which is why FDA did not send Mylan a warning letter.

    Further, FDA officials in interviews with Bloomberg said the number of inspections FDA is conducting does not provide an accurate representation of the agency's oversight of U.S. and international facilities.

    FDA Commissioner Scott Gottlieb said, "It's not the number of inspections we do, it's whether we're targeting effectively."

    Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, which oversees drug inspections, said, "I think our oversight is better than it's ever been. That's my professional judgment of manufacturing worldwide. We know where they are, we know who they are, we know what they're making, we know when we've been there, we know who else has been there. Could we improve? Yes, but I wouldn't look at absolute stark numbers and say that should be a greater or lesser cause for concern."

    Woodcock noted one reason why FDA inspections could be decreasing is because of an agreement FDA reached with the agency's counterparts in the European Union (EU) to use the EU's inspections in European countries rather than duplicating inspections (Edney, Bloomberg, 1/29; Baker, "Vitals," Axios, 1/30; Bean, Becker's Hospital Review, 1/30).

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