The FDA is encouraging drugmakers to invest in production technologies that would bring manufacturing back to the U.S. as several recalls call into question the safety of the global drug supply chain, according to Bloomberg.
The U.S. currently only produces about a quarter of active pharmaceutical ingredients found in commonly-used drugs, according to the Oct. 30 congressional testimony by Janet Woodcock, MD, the director of the FDA's center for drug evaluation and research. The House Energy and Commerce subcommittee on health held the hearing to discuss safety concerns surrounding the global supply chain.
Countries like China and India, which make a range of APIs for commonly-used drugs, have lower labor costs and lighter regulation that reduce costs for U.S. drugmakers who source their APIs from them. Dr. Woodcock said in her testimony that China is home to about 13 percent of the world's registered makers of APIs, a number which has more than doubled since 2010.
When drugmakers source their APIs from other countries, it is difficult for U.S. regulators to police drug quality, according to Bloomberg.
Recently, drugmakers across the globe have had to recall or halt sales of popular heartburn drugs over concerns they contain a carcinogen. Many of the drugs were made with ingredients produced in China and India.
Sourcing APIs from other countries also leaves the U.S. drug supply vulnerable to shortages, Dr. Woodcock said in her testimony, something that happened earlier this year when blood pressure drug valsartan was recalled for containing a possible carcinogen.
Dr. Woodcock said the FDA is encouraging techniques such as continuous manufacturing and 3D printing to help address drug shortages, improve quality and help get drugs to the market faster.
"Using traditional pharmaceutical manufacturing technology, a U.S.-based company could never offset the labor and other cost advantages that China enjoys simply by achieving higher productivity," Dr. Woodcock said.
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