FDA Walks Back CDER Testimony on API Volumes

FDA is walking back misleading testimony it gave the Senate about U.S. production of active pharmaceutical ingredients (APIs). Late last year, CDER director Janet Woodcock testified before an Energy and Commerce Committee hearing that FDA does not know the volume of APIs being manufactured abroad, but last week CDER deputy director Douglas Throckmorton testified at a Senate Finance committee that the Center knew specifically how many APIs are manufactured in the world and that the majority of APIs are made here in the U.S. Throckmorton’s testimony contradicted Woodcock’s earlier declarations that “manufacturers are not required to report to FDA whether they are actually producing an API at a facility, and if they are, the volume they are producing.” Now FDA is walking back his testimony to correct the misleading information, according to Bloomberg News.

The hearing heard recent data from an Government Accountability Office review of FDA’s foreign inspection program and many of the senators were interested in how the agency can help “onshore” critical ingredients and finished products so that they are made in the U.S. Asked how much of the APIs are currently made in China, Throckmorton responded that the U.S. provides about 28%, China about 13% and India 18%. As Bloomberg recognized, these percentages are not the volumes being manufactured, rather the percentages of API facilities registered in those countries. After the hearing, FDA spokesman Jeremy Kahn reiterated to Bloomberg what Woodcock had earlier said — the agency doesn’t know how much API is coming from China or any other country

Woodcock’s testimony noted that pharmaceutical companies typically protect where they buy APIs as a trade secret, making it impossible to know precisely where a drug or its key components originated from in most cases. “China compared to the U.S. is a larger producer of APIs in terms of the output,” Council on Foreign Relations senior fellow Yanzhong Huang told Bloomberg. India supplies a large quantity of finished drug products to the U.S. using Chinese APIs. For example, Bloomberg says that companies in India recently accounted for about 40% of all new generic drugs approvals in the U.S. About 90% of the drugs Americans take are generics. However, Huang noted that India is China’s top API buyer with 70% of its APIs coming from China, meaning many of the finished treatments Indian firms sell in the U.S. are made using Chinese ingredients.