Frequency and Quality of Foreign FDA Inspections

Recommendation

25/26 June 2024
Barcelona, Spain

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In a recent congressional hearing, the US Food and Drug Administration (FDA) was grilled by lawmakers on several issues related to its foreign drug inspection programme. According to an article published in Regulatory Focus, lawmakers raised concerns about a backlog of foreign drug manufacturer inspections, delays in conducting surprise inspections, and vacancies in the foreign inspector workforce.

Frequency and Quality of FDA Foreign Inspections Questioned

The House Energy and Commerce Subcommittee on Oversight and Investigations held the hearing, which focused on the comparative frequency and quality of FDA inspections for foreign versus domestic drug manufacturers. Representative Cathy McMorris Rodgers emphasised the critical importance of foreign facility inspections to ensure the safety and quality of the medicines that many Americans rely on.

Mary Denigan-Macauley, Director of Health at the US Government Accountability Office (GAO), testified about the GAO's longstanding concerns regarding FDA's oversight of the global drug supply chain. While acknowledging the progress the FDA has made in increasing foreign inspections and understanding which facilities need to be inspected, Denigan-Macauley highlighted persistent challenges such as recruitment and retention issues.

Virtual inspections and record reviews are no substitute for in-person inspections

During the COVID-19 pandemic, travel restrictions hampered in-person inspections overseas, so the FDA relied on alternative methods such as inspections by foreign regulators, record reviews and product sampling at the border. However, these measures were not sufficient to replace on-site inspections, resulting in a backlog of inspections.

Differences between US and foreign inspections

Denigan-Macauley raised concerns about differences between US and foreign inspections, including the practice of providing advance notice to foreign facilities, which may allow for corrective action prior to inspection. She also noted the reliance on interpreters provided by the foreign establishment, which could compromise the accuracy of the information gathered.

Surprise inspections in India and China

To address these challenges, the FDA has launched a pilot programme for unannounced inspections in India and China. However, lawmakers have criticised alternative inspection methods such as virtual inspections, highlighting the inadequacy of remote methods compared to in-person inspections. Representative Morgan Griffith questioned the completeness of remote inspections, highlighting their limitations in identifying issues such as unsanitary conditions. He proposed the idea of hiring preliminary inspectors to make initial assessments of overseas facilities, using existing funding.

In response, Rep. Frank Pallone defended the FDA and argued for increased funding and authority to carry out its mission effectively. Pallone highlighted gaps in the FDA's ability to monitor the drug supply chain and emphasised the need for new powers to conduct remote inspections, including livestreaming of plant operations.

Although the FDA did not receive a formal invitation to testify, it expressed its commitment to respond to inquiries about its foreign inspection programme.