Drugs

Senators Want Overseas Drug Inspection Info

Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY), the chairman and ranking member of the Senate Aging Committee, have asked FDA commissioner Martin Makary for information about the agency’s oversight of foreign drug manufacturing and how it may threaten the quality and safety of drugs marketed and sold in the U.S. Their letter to Makary follows a committee hearing on the country’s “overreliance on foreign-manufactured generic drugs and the risks this poses to our seniors and national security.”

Scott and Gillibrand say it appears that CDER is overriding safety-related enforcement actions recommended by the Office of Inspections and Investigations, thus allowing drugs from facilities potentially violating FDA standards to be imported into the country.

They cite the case of Sun Pharma, a major generic drug manufacturer in India, where imports have continued despite repeated violations.

The senators also question FDA’s potential noncompliance with the Uyghur Forced Labor Prevention Act, raising the possibility that pharmaceutical suppliers operating in China’s Xinjiang region may be linked to forced labor.

The letter requests this information from FDA:

the number of classifications CDER has downgraded or reclassified from the Office of Inspections and Investigations recommendations for each year since 2020;
the number of import alert exemptions or carve-outs issued by CDER since 2020;
the number of regulatory meetings for Official Action Indicated classified inspections CDER has held instead of issuing a Warning Letter or Import Alert since 2020;
the number of drugs carved out or exempted from import bans since 2020 that were in shortage or considered to be at risk of shortage;
the definition and metrics CDER uses to define a drug in shortage or at risk of shortage when making reclassification decisions;
how CDER’s Risk-Based Site Selection Model determines which facilities will be prioritized for surveillance inspections;
since 2010, the number of companies that have received an exemption for over five years and still have not passed or applied for reinspection;
in areas with mutual recognition agreements in force, the longest period of time that FDA has allowed a company to operate without a surveillance inspection; and
whether FDA reports to U.S. Customs and Border Protection which drug products contain or may contain parts manufactured in China’s Xinjiang Uyghur Autonomous Region.

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