FDA to outsource manufacturing inspections
to approve the use of more third-party inspectors as the regulatory
body attempts to police a complex global supply chain.
By outsourcing some of the inspections the FDA believes that it can more efficiently use the $275m extra funding which it is hoping to receive. The Government Accountability Office (GAO) has stated that foreign plants are inspected every 13 years as opposed to 2.7 years for facilities in the US, a situation the FDA is hoping to resolve. However, the outsourcing plan has already drawn criticism, primarily targeted at the perceived failure of a similar scheme for inspections of device manufacturers. The FDA has been quick to respond to with Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, telling Reuters: "It is very difficult to see how we could actually cover the entire globe. "If you consider many of these other plants aren't really inspected at all, putting in some type of programme would be better than not covering them." The outsourcing idea was mooted last autumn, when the Bush administration proposed a plan for non-FDA inspections of prescription pharmaceuticals. This would be done on a voluntary basis for products that are not considered to pose too great a risk, with manufacturers paying for the inspections. A very similar setup is used for device manufacturers, and has come under criticism for having low levels of uptake. This has been attributed to a dearth of FDA-approved inspectors, which has allowed them to charge high prices. When faced with the choice between paying for their own inspections or waiting for the FDA manufacturers invariably choose the latter. The FDA had incorporated incentives into the scheme to tempt manufacturers into paying for their own inspections. However, the incentives have failed, with only 12 third-party inspections being conducted since the scheme was implemented. This problem was compounded by the delay in getting inspectors approved by the FDA, with it taking two years for the first to be certified. Mutual recognition of the validity of other regulatory bodies' inspections could alleviate this problem, for example sharing information with the European Medicine Agency (EMEA). Despite these difficulties there are those within the FDA and Congress who believe that the scheme can be made to work. Two bills are currently being drafted by Senator Edward Kennedy and Representative John Dingell but the implementation of the proposals may be hindered by the upcoming presidential election.