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FDA highlights manufacturing quality efforts after recalls, regulatory criticism

  • The Food and Drug Administration issued its annual report Monday on the state of pharmaceutical quality, highlighting its inspection efforts and offering geographic and industry regulatory data.
  • Overall, the industry’s average inspection score in fiscal year 2018 was 7.5, little changed from the 7.7 seen in fiscal year 2017. There has been, however, a fairly wide variation in quality among geographic regions, with China and India on the lower end according to the FDA.
  • The number of drug recalls has stayed steady over the last five years, the agency said. Overall, drug shortages have declined since 2011, but the last fiscal year saw issues with shortages of sterile injectables.

The FDA has faced scrutiny in recent months over a series of heart drug recalls and Bloomberg articles critical of the agency’s oversight process. Regulatory officials in February took the unusual step of defending their practices in a public statement.

Much of the scrutiny has focused on drugs coming from India and China, the countries with the biggest number of pharmaceutical manufacturing sites for the U.S. market — aside from the U.S. itself. Indian sites accounts for 12% , while Chinese plants make up 11% of the total, according to the FDA’s latest report.

Indian and Chinese sites got average inspection scores of 7 in fiscal year 2018, compared with 7.9 for European Union facilities and 7.7 for U.S. plants. EU sites producing generic drugs seeking approval in the U.S. got a score of 8.2, while similar sites in India got a score of 7.

All of those scores show an acceptable level of compliance with good manufacturing practices, the FDA said. Still, they “highlight opportunities for increased outreach to, surveillance of, and enforcement of certain markets.”

A small number of manufacturing sites are responsible for a large number of products sold in the U.S., according to the FDA. Indian sites, for example, make about 2.5 times more products on average than ones in China. The agency has determined the number of listed products at a particular facility is a risk factor considered when deciding where to send inspectors.

The agency said another measure it watches is a swing in registration of sites. In fiscal year 2018, there was a nearly 33% increase in packing and labeling site registrations, possibly suggesting a surge in outsourcing that will result in a more complex supply chain and a need for greater oversight.

U.S. regulators performed 1,346 drug quality inspections in the last fiscal year, which covered about 29% of its site catalog. Most of those inspections were outside the U.S.