Congressional subcommittee to examine FDA foreign inspections

U.S. lawmakers plan to hold a hearing next week that will examine the Food and Drug Administration’s foreign inspection program over safety concerns.

The House Subcommittee on Oversight and Investigations — a subcommittee of the Committee on Energy and Commerce — is holding the Feb. 6 hearing, "Protecting American Health Security: Oversight of Shortcomings in the FDA's Foreign Drug Inspection Program.”

“The FDA’s oversight and enforcement of manufacturing practices have long stood as the gold standard for ensuring Americans can trust the safety and efficacy of prescription drugs and medical devices. However, in recent years, the agency has largely scaled back its foreign manufacturing facility inspection program, raising concerns about whether food, drugs and medical devices are being made in safe and secure conditions,” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.) said in a Jan. 30 press release.

“This hearing, which builds upon our ongoing investigations, will give members a chance to discuss the importance of the FDA’s foreign inspection program, why it hasn’t been widely restarted in countries like India and China, and how this trend affects domestic production,” McMorris Rodgers and Griffith added.

Witnesses have not yet been announced.

The oversight subcommittee is holding the hearing at 10:30 a.m. ET at the 2322 Rayburn House Office Building. The hearing is open to the public and will be livestreamed at energycommerce.house.gov.

Foreign inspections of supplement firms

Natural Products Insider reported in December that FDA in FY23 more than doubled its annual foreign inspections of dietary supplement facilities. FDA audited 40 firms in 17 countries from China to New Zealand. Dietary supplements comprised 3% of total FDA foreign inspections in FY23, compared to 5% in FY22, according to Michael Dutcher, FDA acting assistant commissioner for Human and Animal Food Operations.

“Since FY2023, FDA has resumed a normal cadence of inspections in all program areas,” Dutcher said in an email for this article through an FDA spokesman.

Foreign FDA inspections of firms for compliance with cGMP (current good manufacturing practice) regulations applicable to dietary supplement products increased to 40 in FY23 from 17 in the prior year, according to data obtained by Natural Products Insider from FDA staff and through Freedom of Information Act (FOIA) requests.

In the fiscal year that ended on Sept. 30, 2023, FDA conducted the largest number of cGMP inspections in Canada (7), followed by New Zealand (5), China and Korea (4 each), India and United Kingdom (3 each), Australia and Fiji (2 each).

FDA in FY23 performed a total of 501 inspections under the cGMPs that are incorporated in 21 CFR Part 111, with 8% comprising international audits.