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: 

• 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. 
• 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. 
• 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. 

Additional Governmental Concern with FDA Inspection Inadequacy: 

• 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. 
• In particular, the GAO was concerned that the FDA’s practice of conducting preannounced foreign inspections is ineffective and raises “questions about the equivalence of foreign to domestic inspections.” 

Unannounced Inspection Pilot Program and Discontinuation: 

• From 2014 to 2015, the FDA conducted a pilot program in India that eliminated extended advance notice for inspections.  
• During that time, 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. 

Challenges Posed by China’s National Security Law: 

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

• Section 3112(e) of the CARES Act gave the FDA additional authority to require manufacturers to report certain supply chain information to it. The FDA’s May 9, 2023, letter to the Committee stated that only 44 percent of facilities are reporting the required data to the FDA. Based on the FDA’s letter, a disproportionate percentage of noncompliant API and finished dose formula facilities are located outside of the United States. How many regulatory actions has the FDA enforced against noncompliant foreign facilities regarding the CARES Act reporting requirements? Provide a list of all foreign facilities that have been penalized for noncompliance. Include in your response a detailed description of the action taken by the FDA. 
• The FDA ensures the quality of drugs and other pharmaceutical products through manufacturers’ compliance with facility registration and Current Good Manufacturing Practice (CGMP) regulations. The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) contained several provisions providing the FDA greater insight into the original sources of excipients, API, and finished dosage products. Specifically, Section 703 requires that drug manufacturers identify the name and place of business of all establishments involved in the production of drug excipients, while Section 711 revises CGMP regulations to require oversight over the production of any raw materials for the manufacture of a drug. The FDA has indicated in its recent requests for additional authorities over supply chain information that it does not currently have access to original sources for API and other drug excipients, notwithstanding these and other provisions providing such authorities.  
• Given its authorities under FDASIA, why does the FDA take the position that it does not have visibility into where API and drug excipients are sourced?  
• Explain in detail, how the FDA processes information received under Sections 703 and 711. As part of your response, explain how has the data received under Sections 703 and 711 informs FDA’s foreign inspections programs and drug shortage response efforts? 
• Was the FDA consulted by the Department of Defense regarding its decision to independently test the quality and safety of generic drugs it purchases? If yes, provide communications and documents related to the consultation. 
• How many FDA inspectors are currently conducting foreign inspections? Include in your response how many of these inspectors are operating in each country. 

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.

• You can read the FDA’s response here, which notes that only 44 percent of companies are complying with existing requirements to report information on the volume of drugs made at each facility to FDA.