The drug manufacturing supply chain is complex and global, making it harder for the FDA to keep an eye out for bad players and dangerous products. The vast amount of active pharmaceutical ingredients (APIs) come from low-cost countries like India and China. The FDA now has inspectors in China and is asking a tight-fisted Congress to fund more. To stay ahead of problems, the agency tries to inspect those plants that pose the greatest risks. Now, it says it needs a software system that can sift through a boatload of data and help it figure out which plants those are.
The plan is to create a "Drug Quality data domain" that will help both the Office of Scientific Investigations (OSI) and Office of Manufacturing and Product Quality (OMPQ) decide who should be next on the inspection list. In a request for information (RFI), the agency said it wants an off-the-shelf system that can do "real-time evaluation, priority setting, and reporting to support decision making for the selection of facilities and sites for inspections". The FDA is looking for a vendor with experience in risk and trend analysis as well as modeling and simulation. It envisions the system combing through information from a host of inspection and other reports like those for good clinical practice (GCP), bioequivalence (BE), risk evaluation and mitigation strategies (REMS), pre and post approvals among others.
The emergence in recent years of contaminated ingredients and counterfeit drugs has made clear how complex the supply chain has become. The FDA has more foreign than U.S. drug and ingredient manufacturers it must keep track of. In its budget "justification" to Congress, the agency said inspections of foreign manufacturers jumped 10% last year to 813 inspections in 62 countries, and relied more heavily on inspectors now based outside the U.S. The agency said nearly half of the 46 warning letters issued to foreign manufacturers resulted from inspections by its global staff.
The FDA is also working to set up a system that allows countries to rely on internal inspections. In a report last year on the task facing the FDA, it said, the U.S. now imports 80% of the APIs used in its medicines and 40% of the finished drugs themselves. "Over the next decade, FDA will continue to transform from a predominantly domestically focused Agency, operating in a globalized economy, to an Agency fully prepared for a regulatory environment in which FDA-regulated products know no borders," the report says.
- here's the RFI
- read the FDA report on Global Engagement (PDF)
- get more from Regulatory Focus