November 10, 2020

Warren and Smith Question FDA On Resuming Safety Inspections for Foreign Pharmaceuticals Entering the United States

In March, FDA postponed all inspections of domestic and foreign drug manufacturing facilities; many of these inspections have yet to resume, with FDA foreign inspections dropping by over 60% in 2020. "We are concerned that, absent proper oversight of our drug supply chain and the overseas facilities manufacturing products millions of Americans rely on, patients will face an increased risk of drug contamination or other problems with quality, purity, or potency."

Text of Letter (PDF)

Washington, DC - Today, United States Senators Elizabeth Warren (D-Mass.) and Tina Smith (D-Minn.), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, sent a letter to the U.S. Food and Drug Administration (FDA) inquiring about the agency's quality and safety inspections for pharmaceuticals and drug products entering the United States, and requesting information on how FDA plans to take the necessary precautions to protect the health and safety of its employees once all in-person inspections resume.

Under normal operating procedures, FDA performs inspections of manufacturing facilities and is responsible for maintaining the safety, effectiveness, quality, and security of drugs produced in the United States and abroad. However, due to the COVID-19 pandemic, the FDA announced in March that it would be postponing all inspections of domestic and foreign drug manufacturing facilities. As of today, the FDA is only performing a fraction of its full inspection schedule, with overall foreign inspections declining by over 60% in 2020. 

The lack of foreign inspections is particularly concerning, given the United States' over-reliance on foreign pharmaceutical products. Currently, only 28% of facilities manufacturing active pharmaceutical ingredients used in drugs and 47% of facilities manufacturing finished dosage forms of drugs for the U.S. market are located in the United States. Without adequate inspection of the large share of many drugs and drug products coming from abroad, there may be a high risk that unsafe drugs enter circulation in the country.

"The continued postponement of inspections of foreign manufacturing facilities could pose a danger to the public health of the United States. The failure of foreign manufacturing facilities to comply with regulatory requirements has allowed low-quality and unsafe products to enter circulation in the United States, resulting in a number of large-scale drug quality issues, including the 2008 heparin contamination scandal, in which over 240 people died," the lawmakers wrote.

More recently, the FDA found N-Nitrosodimethylamine, a known carcinogen, in the popular blood pressure medicine valsartan. The contaminant was traced back to one of the largest foreign pharmaceutical ingredient manufacturers, but only after the drug was sold to millions of people in twenty-three countries.  

To better understand how Congress can support FDA's mission of protecting public health in the United States and ensuring the safety of imported drug products while also ensuring the safety of FDA employees conducting inspections during the COVID-19 pandemic, the senators requested answers to their questions no later than November 24, 2020.

In July, Senators Warren and Smith introduced The Pharmaceutical Supply Chain Defense and Enhancement Act, comprehensive legislation that takes bold steps to reinvigorate the United States' manufacturing capacity and end the nation's reliance on foreign countries for critical drugs used by millions of Americans.