FDA May Outsource Some Foreign Inspections
1 CommentBy Ed Silverman // June 13th, 2008 // 3:05 pm
So if drugmakers can outsource the manufacture of active pharmaceutical ingredients, why can’t the FDA outsource the inspections? That’s one possibility being considered by both the agency and some members of Congress amid debate and turmoil over FDA funding and tainted goods, Reuters reports.
Nearly 80 percent of ingredients used in meds sold in the US come from China and India, according to the FDA, but last year, just 83 plants in those countries were inspected. But critics say a multimillion-dollar program to use third-party inspectors to boost inspections of medical devices has flopped.
It took the FDA two years to approve the first private inspectors that can be hired to check facilities. Since then, 12 third-party inspections have been conducted, according to Daniel Schultz, who heads the FDA’s Center for Devices and Radiological health. Another 158 have jointly been conducted with the FDA. “The incentives that we thought were there obviously are not enough,” he tells Reuters.
Still, the Bush administration last fall announced a plan to expand non-FDA inspections to drugs and other imported products. The idea is circulating in Congress, where Democrats are drafting bills. Whether legislation ultimately will call for such a program is unclear. But FDA officials don’t seem to mind the idea.
“It’s very difficult to see how we could actually cover the entire globe,” Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research, tells Reuters. “If you consider many of these other plants aren’t really inspected at all, putting in some type of program would be better than not covering them.”
CMC guy
Not clear would be a benefit as would require experienced and trained Inspectors who need to act as teams. If we could get/build a strong core that had consistency would help. Wonder what authority would they have to enforce changes and doubt would be taken as seriously as an Agency Inspectorate? Actually would be better to seek “ICH” sponsored inspectors supported by FDA/EMEA/MHLW+ since are dealing with global issues. Most importantly China, and India in less ways, need to modernize their Systems so they can become a partner (and not a self serving hinderence as seen with heperin).
Probably more than anything Sponsors need to take the responsibilities to properly select and monitor the supply chains, as is basic cGMP. Companies should be doing own or have third party audits with cooperation and direct info flow to FDA (ICH). FDA still should do spot checks but would not have to necessary visit all places every two years. Critics who don’t trust industry and/or pharma would not accept but IMO could be done effectively.