iNDICA NEWS BUREAU-
A US Congress committee has raised concern over insufficient foreign drug inspections in India, China. The Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs.
House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf raising questions regarding the FDA’s insufficient foreign drug inspections conducted in India and China.
“Pursuant to Rules X and XI of the U.S. House of Representatives, the Committee is conducting oversight of the Food and Drug Administration’s (FDA) foreign drug inspection program. As you are aware, 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. 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,” the letter states.
Cathy McMorris Rodgers has pointed out in the letter that 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 (APIs) are from these two countries, we 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 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. The GAO also expressed concern that the FDA’s practice of conducting preannounced foreign inspections is ineffective and raises “questions about the equivalence of foreign to domestic inspections.”
From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections. Instead, the FDA conducted short notice or unannounced visits and selected sites for the program that the agency believed had significant issues. The pilot program appears to have been successful at exposing widespread misconduct and significant violations of FDA regulations, including falsified quality records. Despite the pilot program’s success, the FDA elected to discontinue it.
“The COVID-19 pandemic stopped most in-person inspections of foreign drug manufacturers from March 2020 until April 2022. 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. In many respects, China presents a more dangerous situation than India. Between fiscal years (FY) 2020 and 2022, the FDA conducted only 40 inspections in China as compared to 131 inspections in FY 2019 alone. On January 8, 2023, the Government of China ended its requirement that international arrivals quarantine for two weeks upon entry to the country. However, the FDA only began in-person inspections in China in April 2023,” the letter points out.
Pointing at “recent, troubling political developments in China” 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.”
The Committee has also posed a number of queries to the FDA and has sought its response by August 1, 2023. FDA has been asked to provide a list of all foreign facilities that have been penalized for noncompliance and include a detailed description of the action taken. Other queries focus on preannounced inspections of foreign manufacturing facilities, the number of FDA inspectors who are currently conducting domestic inspections in each country, vacancies in foreign inspections, and backlog in conducting foreign inspections.
The letter also doubles up as a formal request to preserve all existing and future records and materials in the FDA’s possession. “You should construe this preservation notice as an instruction to take all reasonable steps to prevent the destruction or alteration, whether intentionally or negligently, of all documents, communications, and other information, including electronic information and metadata, that are or may be responsive to this congressional inquiry. This instruction includes all electronic messages sent using official and personal accounts or devices, including records created using text messages, phone-based message applications, or encryption software.”
