7 Nov 2019
U.S. Lawmakers Explore Safety of Pharmaceutical Global Supply Chain
On 30 October, the U.S. House of Representatives Energy and Commerce Committee’s Health Subcommittee held a hearing on safeguarding pharmaceutical supply chains in the global economy. The hearing focused on imported active pharmaceutical ingredients, especially those from mainland China and India.
Janet Woodcock, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, testified that nearly three-quarters of API manufacturers making products for the United States are located overseas, including 18 percent in India and 13 percent in mainland China. The percentage of API manufacturing plants located in mainland China rises to 15 percent for medicines on the 2019 World Health Organisation Essential Medicines List. In fact, the FDA has determined that three WHO essential medicines contain APIs that are manufactured only in the mainland: capreomycin and streptomycin (used to treat Mycobacterium tuberculosis) and sulfadiazine (used to treat chancroid and trachoma).
FDA data show that the number of registered facilities making APIs in mainland China more than doubled between 2010 and 2019. Woodcock explained that the FDA does not know the actual volume of APIs imported into the United States and only knows the number of manufacturing facilities approved. The FDA therefore cannot predict what would happen if mainland China stopped supplying APIs to the United States for any reason, or whether U.S. manufacturers would be able to replace any of that manufacturing if needed. Woodcock spoke of a need for new FDA legal authority to obtain real-time manufacturing data and asked that Congress close certain loopholes that allow API and finished medicine manufacturers to by-pass facility registration and inspection requirements and still sell medicines to the United States.
Health Subcommittee Chairman Anna Eshoo claimed at the hearing that mainland China “flaunts the FDA’s rules”, noting that recent analyses of FDA inspection reports published by STAT News found that mainland Chinese plants “were cited for data integrity issues nearly twice as often as American plants.” According to Eshoo, “these data issues include falsifying drug tests or deleting findings that could indicate contaminated or poor-quality drugs.”
Eshoo pressed Woodcock to increase surprise manufacturing inspections at foreign locations, and Woodcock replied that while “for cause” inspections are unannounced most surveillance inspections are announced. She added that scheduling inspections overseas is a trade-off because “if we send a lot of people to a site that isn’t producing product or open, we waste time.” She also acknowledged that the FDA needs to hire new inspectors but said that funding is not the problem in that case.
Woodcock’s testimony included two examples of problems traced to mainland Chinese manufacturers. In August 2018, the FDA issued an alert that Sichuan Friendly Pharmaceutical Co. was recalling certain lots of porcine thyroid API due to inconsistent quality issues. This API from porcine thyroid glands was used for hypothyroidism medicines. FDA laboratory testing confirmed that Sichuan Friendly’s API should not be used to manufacture or compound drugs for patient use. Moreover, in December 2015 the FDA alerted drug compounders that certain lots of baclofen API manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co. might be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.
A prior U.S. Government Accountability Office report to the Health Subcommittee had raised concerns about medicine imports from mainland China and the committee’s ranking Republican member, Greg Walden, said the panel has requested an updated GAO report.