By Meagan Parrish, Senior Editor Dec 17, 2019 “Much of what we will hear today will sound shocking, not only because of the scary state we find our drug supply in, but also because of how little attention it’s received — and it’s been years in the making,” Anna Eshoo (D-Calif.) said in her opening remarks of a hearing this October for the Subcommittee on Health and the Committee on Energy and Commerce. The focus of the hearing was on safeguarding the pharmaceutical supply chain and Janet Woodcock, the U.S. Food and Drug Administration’s director of the Center for Drug Evaluation and Research (CDER), was in the hot seat facing a Congressional panel. A spate of recalls triggered by contaminated active pharmaceutical ingredients (APIs), many of which were produced overseas, wiped out a significant supply of heart medications in America this year — and Congress wanted answers. What caused the contamination? How did we let these impurities slip into the American drug supply chain? How did U.S. manufacturers lose their foothold in the API market to so many companies overseas? How can the FDA get a better handle on the quality issues surrounding foreign-produced APIs — without causing disruptions to the supply of critical drugs? In the midst of the questioning, Woodcock made an admission at odds with a top official charged with protecting the safety of American drugs. “The generic drug supply is so fragile that the FDA has to make hard choices between enforcing quality at a plant and avoiding a drug shortage. Can you speak to this?” Eshoo asked Woodcock.

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• Food & Drug Adminstration

• Safety

• Supply Capacity

• Pharma Manufacturing

• 12/17/2019

• Article