July 2008

FDA sees third-party inspection of overseas drug manufacturers

The U.S. Food and Drug Administration wants Congress to approve the use of more third-party inspectors to help police a complex global supply chain.

In-pharmatechnologist.com reported by outsourcing some of the inspections, the FDA believes it can more efficiently use the $275 million extra funding.

The Government Accountability Office inspects foreign plants every 13 years as opposed to 2.7 years for facilities in the U.S.

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 (CDER) saying, "It is very difficult to see how we could actually cover the entire globe."

Woodcock is an M.D., and her and CDER's charge is to review new drugs for safety and effectiveness before deciding whether to approve them for marketing. They also ensure product quality and safety remain after marketing.  

Last year, the Bush administration proposed a plan for non-FDA inspections of prescription pharmaceuticals. This would happen on a voluntary basis for products that do not pose too great a risk, with manufacturers paying for the inspections.

There is a similar arrangement for device manufacturers, and it has come under criticism for having low levels of uptake, which is probably because of the dearth of FDA-approved inspectors, which has allowed them to charge high prices.

When faced with the choice between paying for their own inspections and 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 taking place since the idea's inception. Also a problem was 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 (ex: sharing information with the European Medicine Agency.)

Despite these difficulties, there are those within the FDA and Congress who believe the scheme can eventually work.

Two bills are in draft sponsored by Senator Edward Kennedy and Representative John Dingell, but the implementation of the proposals may fall victim to stink associated with the upcoming presidential election.