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Reliance on Foreign Drug Makers Won’t Wane With Virus, FDA Says

June 2, 2020, 10:04 PM

The coronavirus won’t be the last time the U.S. grapples with a pandemic, so it should shore up its domestic drug manufacturing capacity now, an FDA official told lawmakers Tuesday.

The U.S. is heavily reliant on drug manufacturing in India and China, making its supply chain vulnerable during global outbreaks. Drug companies could move more production back to the U.S. using advanced—albeit more expensive—manufacturing techniques that streamline production and minimize environmental impacts more than traditional production measures.

Congress needs to encourage companies to invest in the updated manufacturing processes in the U.S. before the next outbreak hits, Douglas Throckmorton, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, told the Senate Finance Committee.

“Covid-19 won’t be the last time that we’re asked to respond to an emergency of this size,” Throckmorton said. “We need to find ways to strengthen the supply chain. We need to find ways to incentivize a supply chain that’s robust and reliable.”

Reliance on foreign manufacturing is a sign the U.S. should be shoring up domestic drug manufacturing, Sen. John Cornyn (R-Texas) said.

The Senate hearing comes after the Food and Drug Administration announced it would halt its inspections of overseas drug manufacturing due to the pandemic. In mid-May the FDA said it was still “postponing domestic and foreign routine surveillance inspections.”

Mary Denigan-Macauley, a director from the Government Accountability Office, said at the hearing she has “concerns” over pausing inspections.

The FDA still does product testing at the border to ensure imported drugs are what they are reported to be, Judith McMeekin, associate commissioner for regulatory affairs within the FDA’s Office of Regulatory Affairs, said at the hearing.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com