Congressional Scrutiny on FDA's Foreign Inspection Program puts Pressure on Agency

In recent communications, the U.S. Congress has raised significant concerns about the effectiveness and integrity of the Food and Drug Administration's (FDA) foreign drug inspection program, particularly with respect to drug manufacturing facilities in India and China. This oversight has become increasingly critical due to the high reliance of the U.S. pharmaceutical supply chain on these countries, coupled with reports of recurring violations of safety and quality standards by foreign manufacturers. The COVID-19 pandemic has further complicated inspection processes, highlighting the need for robust and transparent inspection protocols to ensure drug safety and efficacy.

Two letters from Congress to the US FDA Commissioner underscore the urgent need for improvements in the FDA's foreign drug inspection program. The primary concerns include the significant variability in inspection outcomes, potential issues of inspector competence and misconduct, the impact of geopolitical developments on inspection efficacy, and the overall transparency and accountability of the FDA's processes. Congress now calls for detailed explanations, and strategic plans from the FDA to address these issues.

The first letter was issued about a year ago (18 July 2023), where Congress raised concerns about the effectiveness of the FDA's foreign drug inspection program but also about the revised China's National Security Law potentially obstructing FDA inspections. Congress saw "troubling political developments in China" which may "may jeopardize the viability of the FDA's in-person inspections".

In the latest letter (from 21 June 2024), the FDA is criticised in more detail, addressing "tremendous variation in inspection outcomes". Some inspectors consistently found compliance issues, while others found none, raising concerns about inspector competence and potential misconduct ("the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors").

The congressional letters emphasize that many of the FDA's current challenges are not new but are instead persistent issues that have resurfaced or been exacerbated by recent events. By drawing attention to these long-standing problems, Congress aims to prompt a more effective and transparent approach to the FDA's foreign inspection program, ensuring the safety and reliability of the U.S. drug supply chain.
Further information was now requested, like detailed records of inspections and FDA's interactions with facilities in India and China, data analytics, inspector selection processes, background checks, and responses to foreign inspection refusals. Furthermore, FDA should explain how the agency "plans on increasing the number of routine inspections in these countries".

Pilot Program Insights

The reference to the 2014-2015 pilot program in India, which eliminated extended advance notice for inspections, underscores the FDA's historical challenge of conducting effective inspections. This program revealed significant issues when inspections were unannounced, highlighting systemic problems that otherwise went unnoticed. Despite its success, the discontinuation of the program points to a reluctance or inability to sustain these effective oversight practices.