Warren wants answers on suspension of FDA inspections of overseas drug manufacturing facilities

  • Democratic Sens. Elizabeth Warren and Tina Smith are concerned about the safety of pharmaceuticals and drug components coming into the United States.
  • The coronavirus pandemic has put a halt to many inspections of overseas drug manufacturing facilities.
  • The lawmakers say the failures of foreign manufacturers to comply with U.S. regulations have put patients at risk.

Democratic Sens. Elizabeth Warren and Tina Smith are concerned about the safety of pharmaceuticals and drug components coming into the United States, as the coronavirus pandemic has put a halt to many inspections of overseas drug manufacturing facilities.

In a letter to FDA Commissioner Stephen Hahn released Tuesday, the senators wrote: "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."

On March 10, the Food and Drug Administration announced it would postpone on-site inspections. Right now, inspections are only happening on a case-by-case basis and are limited to those described as mission-critical, pre-approved, or for cause. Routine surveillance inspections aren't happening at all.

Of the inspections that are being done, many are conducted remotely, by requesting records and other information from the facilities.

The lawmakers say the failures of foreign manufacturers to comply with U.S. regulations have put patients at risk. In 2008, contamination in blood-thinning medication heparin, which is sourced from China, resulted in 240 deaths. In 2018, the FDA found N-Nitrosodimethylamine, a known carcinogen, in batches of the blood pressure medication valsartan and traced it back to a Chinese manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd. The products were voluntarily recalled.

According to the FDA, just 28% of facilities making active drug ingredients and 47% producing finished drugs for the U.S. market are located in the United States, with many facilities located in China and India.

"With such a significant amount of drugs and drug ingredients arriving from abroad, it is imperative that the FDA take all steps necessary to ensure drug quality and safety," Warren and Smith said in the letter.

The FDA says it has increased physical exams of products arriving at U.S. borders through sampling and testing before they enter the market. But there are concerns about whether the FDA can keep up with border inspections, given the huge number of imports.

The FDA said Tuesday it "will review the letter and will respond directly to the Senators."

In July, Warren, of Massachusetts, and Smith, of Minnesota, introduced the U.S. Pharmaceutical Supply Chain Defense and Enhancement Act, which would provide the federal government with additional information regarding the nation's drug supply chain. 

Under their proposed legislation, drugmakers would be required to report to the FDA each year the source of active pharmaceutical ingredients and starting materials used to make drugs that are consumed in the United States. 

It also requires the FDA commissioner and the secretary of Defense to develop a confidential list of "critical drugs" deemed essential for public health and national security.

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