The Senate is preparing to reauthorize the FDA's all-important user-fee funding. But that's not all the latest Prescription Drug User Fee Act would do. The FDA would get new powers to police imported drug ingredients and inspect overseas facilities, and drugmakers would face new requirements for reporting production problems that might lead to shortages.
As The Wall Street Journal reports, about 80% of the raw materials used in drugmaking comes to the U.S. from overseas, particularly China and India. The FDA has limited power to inspect overseas facilities--and limited resources and staffing, too. Those limitations came in for a barrage of criticism several years ago, when tainted heparin sourced in China was linked with 81 deaths.
So, changes have been brewing for awhile. The agency got some additional funding for foreign oversight. It opened an office in China. It's working with other regulatory agencies around the world on reciprocal recognition of inspections. Under the new legislation, the FDA would also be able to block products at the U.S. border if FDA inspectors weren't allowed to check the facilities where they were made. The agency would also be able to apply its risk-based inspection approach worldwide, so foreign plants would be more likely to get attention from FDA inspectors.
Meanwhile, anyone who's been following pharma knows that drug shortages have plagued the industry over the past year or so. Both the House and Senate versions of the bill would require companies to alert the FDA early on when they're experiencing production issues that could trigger shortages.