13/14 December 2023
On July 18, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter raises questions regarding the FDA's insufficient foreign drug inspections conducted in India and China.
The FDA's recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical. Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from these two countries, the Republicans are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.
Chinese and Indian manufacturers receive the most FDA Warning Letters. These violations have included: carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes. The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022. In lieu of in-person inspections, the FDA resorted to alternatives and workarounds, such as remote interactive inspections of drug manufacturing facilities on a voluntary basis, according the letter. Once FDA inspections resumed, they did so at a much lower level than before the pandemic.
One analysis found that out of approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6 percent of them, with just 3 percent of Indian manufacturers being inspected. Between fiscal years (FY) 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 inspections in FY 2019 alone.