FDA’s Foreign Drug Inspection Program
I recently chaired a hearing in the Oversight and Investigations Subcommittee of the Energy and Commerce Committee, in which we examined the effectiveness, and shortcomings, of the U.S. Food and Drug Administration’s (FDA) foreign drug inspection program.
Since 1955, the FDA has conducted international inspections on products regulated by the agency to ensure foreign facilities, laboratories, processing sites, etc. comply with U.S. law.
As according to the FDA, Americans should have confidence that products manufactured outside the U.S. meet the same safety and quality standards as those manufactured domestically.
But, in the program’s current state, this is far from the case. In fact, the FDA’s lack of foreign inspections is alarming, and its consequences can be deadly.
The Subcommittee held a hearing on this subject in December 2019 in which we discussed a number of issues with the program. For example, all of the FDA’s foreign inspections were pre-announced, giving foreign facilities 10-12 weeks advanced notification (U.S. facilities do not get advanced notification). And even with prior notification, the FDA found deficiencies during 66% of foreign inspections, including serious deficiencies in 16% of those inspections.
Unfortunately, due to the COVID-19 pandemic, challenges with the program only increased.
From March 2020 through February 2022, the program essentially ceased functioning. For example, from March to October 1, 2020, the agency performed only three foreign inspections. In 2018 and 2019, the agency performed more than 600 inspections during that same time period.
Additionally, pre-announced in-person inspections were replaced by zoom calls.
Though zoom certainly has its benefits, what do inspectors miss when they aren’t on site to see the interworking of how a facility is being operated?
Over zoom they can not see if a rat skitters across the floor or if documents are being destroyed in a barrel out back.
Currently, I am most concerned by the FDA’s lack of inspections in India and China, as these two countries comprise the majority of foreign manufacturing sites of generic drugs on the U.S. market.
In a recent analysis of data by ProPublica, it was shown that the FDA only inspected three percent of Indian manufacturers in 2022, while in 2019 they inspected 45 percent.
As I mentioned above, this can lead to deadly consequences, as was seen in 2023, not with drugs but with eyedrops. Eyedrops produced in a plant in Tamil, India infected 81 people in the U.S. with a rare strain of extensively drug-resistant P. aeruginosa; three died and eight were blinded. The plant in which they were manufactured never received an inspection from the FDA.
With more and more of our drugs being made oversees, this lack of FDA oversight is unacceptable.
There have also been recurrent reports of data destruction and falsification by Indian and Chinese manufacturers, which is extremely alarming.
The FDA attributes its challenges, specifically its low inspections rates, to not having enough investigators within the agency.
One idea I mentioned during our hearing, to help alleviate this problem, is to have preliminary inspectors within the agency, someone who might not meet the educational or training standards of a full-fledged inspector, but who can at least go into facilities and do cleanliness inspections.
These preliminary inspectors can be people who have just graduated college or those who have a desire to see different parts of the world. They can be paid a low-cost stipend while helping Americans receive safe medicines. After a few weeks’ training they can begin preliminary inspections of foreign drug manufacturing sites. They can then report on how clean a facility is and whether they saw anything that looked amiss. This will give the FDA information to prioritize full inspections, as a facility that doesn’t have clean bathrooms and floors likely has other issues on the processing line.
Regular reviews by Congress on the current state and effectiveness of the foreign drug inspection program are essential to ensuring work is being done to improve the program, especially given the setbacks from COVID-19. I was very disappointed that the FDA did not send a witness to testify during our most recent hearing, as Congress, and Americans, should hear directly from the agency on what steps they are taking to improve the program.
I will continue to provide oversight over the program and plan to have more hearings on the subject. If the FDA proves unwilling to work with the Subcommittee, I will move to other means within the Subcommittee’s power to ensure they cooperate.
If you have questions, concerns, or comments, feel free to contact my office. You can call my Abingdon office at 276-525-1405 or my Christiansburg office at 540-381-5671. To reach my office via email, please visit my website at https://morgangriffith.house.gov/.
