FDA halts food, drug and medical device testing overseas through April

FDA halts food, drug and medical device testing overseas through April
© Greg Nash

The Food and Drug Administration (FDA) said this week it will halt regular inspections of overseas food, drugs and medical items through April due to the coronavirus outbreak.

FDA Commissioner Stephen Hahn said in a statement Tuesday that most inspections would cease through April. He also said exceptions would be made for product checks that are considered “mission-critical,” generally facilities where evidence of a violation of good manufacturing practices already exists.

Inspections in China have already been withdrawn, with similar actions in India, a leading manufacturer of generic drugs. Experts estimate that almost 80 percent of ingredients for generic medicines are made in India or China, The New York Times reported.

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Barbara Unger, a specialist who tracks FDA regulatory actions around the world, found that in fiscal 2019 the agency issued 16 warning letters to factories in India and 15 to plants in China, accounting for a bulk of the 43 warning letters issued within the same year to overseas drug manufacturing plants, according to the Times.

The agency employs around 200 workers conducting overseas drug inspections, the Times reported.

Rosemary Gibson, an expert on China’s drug supply who is a senior adviser at the Hastings Center, a nonpartisan bioethics research institute, voiced concern that the absence of FDA oversight could be problematic.

“At a time when there are shortages of medicines — critical medicines — there’s a lot of untoward activity that can take place, like counterfeits and poor quality products,” she told the Times. “The bottom line is, who is going to be checking?”

Thirty-two percent of vegetables, 55 percent of fruits, and 94 percent of seafood consumed in the U.S. is imported. Among the 109,000 foreign facilities registered with the FDA, the agency inspects only about 1,600 of them each year, according to the Times.

“The FDA has always struggled to meet its foreign food inspection targets, and this is going to set them back even further,” Sarah Sorscher, a deputy director of the Center for Science in the Public Interest, told the Times.

Hahn said the agency would utilize practices of the past when inspections were not possible, such as sampling products at the U.S. border and examining companies with weaker compliance histories.