Republican leaders on the House Energy and Commerce Committee are raising more questions about the FDA’s inspections in India and China after finding inconsistencies in the way some inspectors have operated, including signals that some were considerably more lenient than their peers.
The letter, dated Friday, said the committee analyzed FDA inspection outcomes in India and China from January 2014 to April 2024, reviewing the work of inspectors with 10 or more inspections in either country.
Ensuring drug quality in India and China has been a challenge for the agency. Both countries have had repeated cases of everything from shredding quality records, data integrity questions and allegations of outright fraud. But the committee said its review found that some inspectors found many violations, while others found almost none.
“Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue,” E&C Chair Cathy McMorris Rodgers (R-WA), Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) wrote to FDA Commissioner Rob Califf.
Specifically, the representatives said two unnamed FDA inspectors never found any compliance issues after a combined 24 inspections in India. Another inspector found zero compliance issues in 20 out of 23 inspections (85%) in China while identifying compliance issues in domestic inspections during the same period.
“By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted,” they wrote, raising questions later in the letter about bribery.
The agency was also asked about a drop in the number of inspections during the pandemic.
The agency’s inspections in India and China declined in the late 2010s, and then significantly again during the pandemic, with the FDA conducting just three foreign inspections from March to Oct. 1, 2020. That fall-off was one focus of the committee’s inquiry.
“Explain in detail the FDA’s understanding for why the rates of Warning Letters and OAI [official action indicated] classification for facilities in Asia Pacific China and India have dropped since the Covid-19 pandemic,” the lawmakers asked the FDA in the letter.
The FDA told Endpoints News it will respond to the letter.
“We understand the importance of our foreign inspection program for the health and safety of the American public and the FDA has been responsive to the Committee’s inquiries on this issue,” a spokesperson said.
The letter also asks the FDA when it plans to start an unannounced inspection program in China. Former FDA deputy commissioner Janet Woodcock previously told Congress that the FDA did not conduct unannounced inspections in China and other foreign countries because it wanted to ensure the appropriate personnel were on site when inspectors arrived.
The same Republicans on the House E&C Committee also took issue with FDA’s foreign inspection program in late 2023, and held a hearing on the topic in April.
Article updated with FDA comment.