Today is the deadline set by U.S. Senators Elizabeth Warren and Tina Smith for the Food and Drug Administration to respond to questions regarding the safety of imported drugs during the ongoing pandemic. More than half of drugs and nearly three-quarters of active ingredients sold in the U.S. are made overseas.
The senators are concerned about reductions in on-site quality inspections of foreign drug manufacturing facilities, which have plunged more than 60% since March. As the pandemic took hold, the FDA responded to public health concerns by temporarily postponing both foreign and domestic inspections, except for those considered “mission-critical” on a case-by-case basis.
While the FDA announced plans to resume “prioritized” domestic inspections this summer, the suspension of most foreign drug plant inspections continues.
In a detailed three-page letter dated Nov. 10, the two Democratic senators requested an update on the agency’s plans for ensuring patient safety as well as the safety of employees once foreign drug inspections restart. Warren, the former presidential contender from Massachusetts, and Smith, from Minnesota, are members of the Senate Health, Education, Labor and Pensions Committee which oversees the FDA.
"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," the senators wrote to FDA Commissioner Dr. Stephen Hahn.
Warren and Smith requested detailed information including:
- The number of foreign drug plant inspections that have been conducted, postponed or canceled outright since March
- How the FDA decides which inspections are “mission-critical”
- How the FDA will decide when it’s safe to resume the normal inspection schedule
- What additional resources the FDA might need in order to “adequately conduct” foreign drug plant inspections during the pandemic
In 2008, 240 people died after using a contaminated blood-thinner that had been sourced from China, as CNBC reported. The same year, the FDA discovered that batches of a blood pressure medication made in China were tainted with N-Nitrosodimethylamine, which has the potential to cause cancer when taken in large doses over time, per CNBC.
The issue of dirty and unsafe drug manufacturer facilities overseas was the subject of the 2019 bestselling book, Bottle of Lies.