E&C Republicans Press FDA Over Inadequate Inspection of Drug Manufacturing in India and China

Washington, D.C. — 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. The letter raises questions regarding the FDA’s insufficient foreign drug inspections conducted in India and China.

KEY EXCERPT:

“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. […] Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients 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.”

KEY BACKGROUND FACTS:

FDA Foreign Inspections:

Additional Governmental Concern with FDA Inspection Inadequacy:

Unannounced Inspection Pilot Program and Discontinuation:

Challenges Posed by China’s National Security Law:

The Chairs requested answers related to questions, including the following, by August 1, 2023:

CLICK HERE to read the letter.

BACKGROUND ON THE COMMITTEE’S DRUG SHORTAGE EFFORTS:

July 12, 2023: Chair Rodgers announces plans to release drug shortage discussion draft following robust response to RFI.

June 12, 2023: Chair Rodgers and Ranking Member Crapo (R-ID) sent an RFI to stakeholders and experts.

May 11, 2023: Chair Rodgers and OI Subcommittee Chair Morgan Griffith (R-VA) convened a hearing titled “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains.”

March 27, 2023: Chair Rodgers, Subcommittee Chair Griffith, and Subcommittee on Health Chair Brett Guthrie (R-KY) wrote to the FDA requesting information into how the agency is managing drug shortages.