Washington DC - House Energy and Commerce Oversight and Investigations Subcommittee Chairman Morgan Griffith (R-VA) delivered the following keynote address to today's subcommittee. audience about the FDA's foreign inspection program.
LACK OF INFORMATION ABOUT FOREIGN MANUFACTURERS
“Today's hearing is an opportunity to examine the FDA's foreign drug inspection program.
“I would be remiss if I did not point out that I am disappointed that the FDA refused to provide a witness after being invited to participate in this hearing.
“Periodic reviews of the current status and effectiveness of the agency's foreign drug inspection program are an important oversight function.
“It is an area that this Committee has been able to work on in a bipartisan manner for many years.
“More and more of our medicines and their bulk active pharmaceutical ingredients (APIs) are coming from foreign countries. This is especially true for generic drugs, where manufacturers in China and India make up the majority of facilities supplying the U.S. market.
“Also, India relies heavily on China for its bulk API when manufacturing medicines.
“Unfortunately, we do not know the actual quantity of drugs or bulk APIs that come from foreign manufacturers. The FDA itself has even admitted it.
“Congress passed a provision in the CARES Act of 2020 that requires any manufacturer registered with the FDA to annually report drug substance and volume data, including API. Only about 50 percent of manufacturers comply.
“The last time this Subcommittee held a hearing on this topic in December 2019, before the known onset of the COVID-19 pandemic, there was reason for cautious optimism that the FDA was taking steps to increase the number of foreign inspections.” and expand the scope of foreign inspections. inspection program to better meet the demands of our global pharmaceutical supply chain.
“The FDA inspectorate team was almost complete. The number of foreign inspections carried out in India increased from 207 in 2016 to 305 in 2019, and around 70 per cent of those inspections were surveillance inspections.
“The FDA was implementing mutual recognition agreements with European regulatory agencies that would reduce overlapping inspections and improve the sharing of inspection records, freeing up resources to focus on high-risk facilities.
“However, serious deficiencies still existed. All foreign inspections were previously announced.”
COMPLIANCE BREACHES BY FOREIGN MANUFACTURERS
“Prior to 2020, the FDA gave foreign facilities ten to twelve weeks' notice, compared to zero advance notice for U.S. facilities.
“It is alarming that, given this advance warning, the FDA still found deficiencies during 66 percent of foreign inspections, including serious deficiencies in 16 percent of those inspections.
“The FDA also took too long to act: in 2019, the agency took an average of 136 days to issue an import alert.
“Any intermittent and halting progress the FDA has made to strengthen its inspection program abroad has been undone by the COVID-19 pandemic, and to date, the FDA has been slow or unable to get inspections back on track at home.” abroad".
THE FDA IN DEVELOPMENT SINCE COVID
“From March 2020 to February 2022, the FDA's foreign inspection program essentially ceased to operate. The FDA conducted only 21 foreign inspections in the 12 months following the March 2020 pause announcement, compared to 977 foreign inspections in 2019. Previously announced inspections were replaced by alternatives, such as Zoom tours.
“Currently, according to the FDA, there is only one researcher based solely in China and five based solely in India. This labor shortage presents a huge problem when trying to review the backlog at foreign facilities.
“It is not surprising that, in the absence of inspections and regulatory actions, we have seen numerous failures in the quality control of imported medicines.
“It is promising to see the FDA implement its overseas unannounced inspection pilot program with both China and India. The goal of this pilot program is to increase unannounced surveillance inspections of foreign pharmaceutical facilities.
“Since March 2022, the FDA has completed 35 unannounced and short-notice inspections in India. I hope they continue to implement this program and that it leads to changes within the FDA for foreign inspections.
“China, on the other hand, is a completely different story. The FDA has not completed any unannounced or short-notice inspections since the pilot program began.
“The FDA has even stated that sometimes when its inspectors arrive at facilities, they are prevented from inspecting companies in China.
"This is unacceptable.
“In addition, China's new interpretation of its national security law criminalizes the release of routine trade records, including information the FDA needs for meaningful inspections.
“We need to start thinking about whether we should continue to rely on drugs and/or APIs from such a closed regime.
“Without a functioning foreign inspection program, one that includes unannounced inspections and imposes real consequences for failing to maintain good manufacturing practices, we have lost the ability to deter negligent actors who put Americans at risk.
“Once again, I am disappointed not to have the FDA here.
“We will have additional hearings on this issue. And in future hearings, if the FDA does not voluntarily attend, we have other means to ensure their attendance.”
