If U.S. lawmakers wanted reassurance that the pharma supply chain is secure, then they must have been disappointed. At a Capitol Hill hearing yesterday, the Government Accountability Office warned that foreign-made drugs and ingredients still aren't getting enough FDA scrutiny. And the drug watchdog's Deputy Commissioner Deborah Autor promised that another heparin-esque safety crisis is inevitable if the FDA doesn't get more power and resources.
It's "not a matter of if, it's a matter of when," Autor told the U.S. Senate Health, Education, Labor and Pensions Committee, referring to the sort of safety problem that plagued Baxter International in 2008, when the company's heparin blood thinner was found to be contaminated. The tainted product, whose supply chain originated in China, was linked with severe reactions in hundreds of patients and more than 100 deaths.
These days, 40% of drugs dispensed in the U.S. are made overseas, and 80% of active pharmaceutical ingredients are foreign-made, Bloomberg reports.
The GAO agreed with that assessment; its director of healthcare, Marcia Crosse, told the committee that the FDA has amped up its inspections in foreign facilities, but the 27% increase in facility visits isn't nearly enough to make sure that foreign-made drugs and APIs are safe. "FDA needs to act quickly to implement changes across a range of activities...to better assure the safety and availability of drugs for the U.S. market," Crosse said. For instance, the agency needs to track down all the locations of foreign facilities exporting to the U.S., find out what facilities ship what products and verify their ownership, she said.
The FDA says U.S. law hampers its foreign policing efforts. The agency wants the authority to suspend foreign facilities if they don't deliver timely information about their work and to require overseas plants to use a unique identifier number to help keep track of products moving through the supply chain, MedPage Today reports.
Plus, as Autor told the committee, the agency wants power to order recalls, rather than having to work with drugmakers to institute them. And FDA wants to set up a track-and-trace system to follow products from manufacturer to pharmacy. Committee Chair Tom Harkin (D-IA) has promised a bipartisan bill to help secure the drug supply, Bloomberg says.