FDA makes strides in inspection effort but challenges persist

Before a generic drug can make it to market in the U.S., the facility where it will be manufactured must be inspected and approved by the FDA. But with generic drug applications piling up, the agency is having trouble getting to many of those, although it is making progress in catching up.

In a report to Congress this week, the Office of Inspector General (OIG) said that the number of inspections of generic drugmakers, preapproval and so-called surveillance inspections, were up to 243 in 2013 from 149 in 2011, a 63% jump. The vast majority of those were combined inspections for both preapproval applications and to check on general GMP conditions.

The report was issued by the OIG because of concerns among lawmakers about the safety and effectiveness of generic drugs. The concerns were prompted in part by high-profile problems like those that led Indian drugmaker Ranbaxy Laboratories, now owned by Sun Pharmaceutical, to plead guilty in 2013 to civil charges for faking drug data. With 80% of U.S. prescriptions being for generic drugs and with the majority of those coming from foreign suppliers, Congress has been worried that the FDA is not able to reach the level of oversight needed to keep consumers safe.

The report found that the FDA's efforts have turned in mixed results. While the FDA performed 142 ANDA preapproval inspections of foreign manufacturers in 2013, up 40% from the 101 it did in 2011, the share of foreign manufacturers inspected fell to 50% that year from 60% two years earlier. Part of the problem, of course, is the logistics of getting inspectors into foreign locations, the OIG said.

The OIG sees hope in the fact that in 2013, Congress approved new fees for the FDA to use in part to cover the costs of foreign inspections and it has been spending that money to boost its inspection staff in countries like India and China. The report said the FDA raised $300 million in 2013 from the Generic Drug User Fee Act. 

But even with more money, the FDA has faced frustrations. In fact the agency has spent the past several years dealing with authorities in China who have held up visas for its proposed boost in the number of inspectors based there. Even intervention by officials as high as Vice President Joe Biden has not broken that logjam. China is of key importance because it produces the vast majority of APIs used in drugs manufactured for the U.S. and its own oversight is notoriously lacking.

But the report had some good news. In an effort that goes directly to the concerns of some members of Congress, the OIG discovered that "in 2013, FDA conducted surveillance inspections of all generic manufacturers that it had identified as high risk."

- here's the report (PDF)