FDA Skips Foreign Inspection Hearing
FDA declined an invitation to testify about its foreign inspection program at a 2/6 House Energy and Commerce Oversight and Investigations Subcommittee hearing and received heat from chairman Morgan Griffith (R-VA) over their absence. Other inspection-related hearings will be planned in the future and if FDA rejects the subcommittee’s next invitation, then committee leaders will lean on their powers, including a subpoena, to make sure the agency provides needed testimony, Griffith hinted. “Regular reviews of the current state and effectiveness of the agency’s foreign drug inspection program is an important oversight function,” he reminded the hearing.
“More and more of our drugs and their bulk active pharmaceutical ingredients (APIs) come from foreign countries,” Griffith said in his opening statement. “This is especially true of generic drugs where manufacturers in China and India comprise a majority of facilities supplying the U.S. market. Unfortunately, we do not know the true number of medicines and the bulk API that come from foreign manufacturers. FDA has even admitted this themselves. Congress passed a provision in the 2020 CARES Act that requires any manufacturer who is registered with the FDA to annually report drug substance and volume data, including APIs, and only about 50 % of manufacturers are in compliance.”
Ranking member Kathy Caster (D-FL) noted that Americans rely on a strong FDA to oversee the many drugs that are manufactured overseas. Because FDA does not have total control over the global supply chain, its “ability to conduct foreign inspections needs to be well-funded, well-staffed and well-equipped with the authorities it needs to maximize its mission,” she noted, adding that the ongoing concern is that “Republicans in Congress have routinely asked our public health agencies to do more work without providing the resources that they need to get the job done.”
Witnesses at the hearing provided input on the current state of foreign inspections and offered suggestions that could be implemented to improve the process. For example, former Ranbaxy employee and whistleblower Dinesh Thakur (see earlier story) recommended that legislation be enacted to require mandatory end-user testing on drugs entering the U.S. from countries where past inspections have documented data manipulation and serious GMP violations.
Thakur said that “such testing can be limited to random statistical sampling or potentially risky drugs with known manufacturing issues, such as injectables… This will cost money; but there is simply no alternative at this stage when public confidence in the foreign inspection program appears to be at an all-time low. The data generated by these testing programs will provide us with an independent source of data to assess how effective the U.S. FDA’s foreign inspections program is.”
Hyman, Phelps & McNamara and former Justice Department attorney John Claud recommended that FDA continue to expand its reliance on international regulatory bodies’ inspection findings under mutual recognition agreements. “Additionally, FDA has made some inroads into utilizing remote inspections,” he said. “The agency lags behind other countries in this area, and expanding this program where appropriate might help alleviate some of the foreign inspection backlog. FDA also has programs in place to allow certified and validated third parties to provide inspection material for regulated companies in the medical device and food space. Well, those programs are limited and voluntary, but similar initiatives might be appropriate here.”
Additionally, Rep. Griffith even suggested that FDA consider using “preliminary inspectors,” which would be lower-level inspection staff who may not have the educational level of a full-fledged inspector. The preliminary inspectors could visit foreign sites and rate them on cleanliness and other non-chemistry factors. He said dirty facilities are likely to be out of control and are probably more likely to have problems on the manufacturing line. A follow-up inspection can then be ordered to assess the facility by a fully trained investigator.