The FDA may look to outsource inspections of foreign drug manufacturing and supply plants, the agency’s acting deputy commissioner said at an industry forum last week. The resource-strapped agency has been focusing on how to execute its oversight duties in an increasingly global and fragmented supply chain.
“We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves,” Acting Deputy Commissioner John Taylor said, according to Bloomberg reports. “We’re looking at anything, anything and everything that will allow us to leverage our resources better.”
It’s good that FDA is looking at creative ways to close gaps that exist in oversight. Recent GAO reports show that thousands of foreign plants that make raw materials and APIs for American prescription and over-the-counter drugs go uninspected each year. In a post-heparin world, the infamous stat—that a foreign drug plant gets inspected by FDA on average every 9 years, compared with an average of 30 months for domestic plants—looms large.
Here are some questions worth asking as FDA explores this idea:
- Who will pay for third party inspections?
- How will third party inspectors be certified?
- What level of recognition will these inspections receive from the agency?
- What other strategies can FDA use to leverage resources?
- To what extent can or should the agency recognize inspections by foreign regulators?
But why agree to third-party inspections when you can just wait for the FDA (and wait, and wait?) A similar system in place for medical devices now suggests the waiting game may be preferred among companies, but that could change if legislation creates new industry fees to support FDA inspections, or if inspection were tied to permission to import.
There’s been a good deal of legislative action on these issues in recent Congresses and we hope for and expect strong solutions that help close oversight gaps will be brought to the table in this one.
–Kate Petersen, PostScript blogger