FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Woodcock to Congress: U.S. Must Revamp Manufacturing to Spur API Production

Nov. 11, 2019
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CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in remarks to a House subcommittee.

The growing number of API manufacturing sites in China and other countries suggests the U.S.’ reliance on these countries for APIs is increasing, Woodcock told lawmakers on the Energy and Commerce committee’s health subcommittee in a hearing on protecting the drug supply chain.

Woodcock noted that the agency does not know the exact volume of Chinese APIs that enter the U.S. market, just the number of exporting facilities. Congressional action would be needed to require API suppliers to provide the information, she said.

Only 28 percent of facilities making APIs for the U.S. market are domestic, while 72 percent are overseas. China accounts for just 13 percent but concerns at the hearing focused on that source.

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