FDA's Criticized Overseas Inspection Program

The U.S. House of Representatives Committee on Energy and Commerce oversees the FDA's foreign drug inspection program.  Members of the Committee have expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program at two separate hearings before the Subcommittee on Oversight and Investigations and the Subcommittee on Health.  On July 18, 2023, the Energy and Commerce Committee sent a letter to FDA Commissioner Robert and Secretary Califf regarding GMP inspections in India and China.

The Committee is particularly concerned about 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. 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. Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from these two countries, they are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.

The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022. According to the letter, 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.
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.

The Committee is not alone in voicing concerns. The Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs. The non-partisan Government Accountability Office (GAO) also criticized the FDA’s foreign inspection program in a report published last year, noting that the FDA faced “unique challenges” and that it is inadequate at holding foreign manufacturers accountable for repeatedly violating regulations.6 In particular, the GAO was concerned that the FDA’s practice of conducting preannounced foreign inspections is ineffective and raises “questions about the equivalence of foreign to domestic inspections.”

Moreover, there have been recent, troubling political developments in China that the Committee believes may jeopardize the viability of the FDA’s in-person inspections there. Last month, the ruling Communist Party of China announced a reinterpretation of its already sweeping National Security Law to expand the scope of the law beyond state secrets to cover “data, materials, or items related to … national interests.” The law’s new interpretation is so broad that it would allow officials to arrest FDA inspectors or block access to manufacturers’ records if officials deem it in the national interest. Authorities have already raided the offices of companies that specialize in collecting market information in China and detained employees.
In light of these situations, the committee has posed 22 questions to the FDA, requesting answers by August 1. For example,

The above questions are excerpts, but some of them are quite harsh, as is typical in the U.S. It is unclear how the FDA responded, but it would be interesting to think what would happen if the same questions were asked of the Japanese Ministry of Health, Labor, and Welfare or PMDA.

Although the stable supply of pharmaceuticals and quality assurance are two opposing sides of the same coin, they are unavoidable issues for pharmaceutical manufacturers, and it is necessary for them to check the quality of at least the main raw materials they use themselves, without relying on inspections by public agencies.

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