Senators say Patients May be Facing Increased Risk of Drug Contamination or Other Quality, Purity, Potency Problems Due to COVID’s Impact on Inspections

WASHINGTON, D.C. [11/10/20]— U.S. Senator Tina Smith (D-Minn.) and Elizabeth Warren (D-Mass.) 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. 

Under normal operating procedures, the FDA inspects 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 coronavirus (COVID-19) pandemic, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities in March. 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.

Sens. Smith and Warren say that the lack of foreign inspections is particularly concerning given the United States' over-reliance on foreign pharmaceutical products. 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. Additionally, the senators say the FDA must take the necessary precautions to protect the health and safety of its employees who conduct in-person inspections once they resume.  

"The continued postponement of inspections of foreign manufacturing facilities could pose a danger to the public health of the United States,” wrote the senators. “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.”

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.   

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. 

You can read a copy of the letter here.

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