A preliminary deal has been reached to dramatically increase inspections by U.S. authorities of generic drug manufacturing operations in China, India and other foreign countries.
As The New York Times reports, generic drug companies have agreed to pay $299 million annually to underwrite U.S. government inspections of foreign manufacturing plants. The landmark pact, which is expected to win Congressional approval easily, is intended to address long-running concerns about contaminated generic medications produced at shadowy foreign plants that have rarely, if ever, beem inspected by U.S. officials.
A government report last year said that about 64 percent of 3,700 drug facilities overseas have never been inspected by the U.S. Food and Drug Administration. At its current pace, the FDA would take more than 13 years to check every foreign drug plant exporting to the U.S., but the agreement calls for inspections every two years, the same as for U.S. plants.
For the generic drug companies, the deal could raise confidence in an industry that repeatedly has been roiled by scandals over tainted ingredients. In a 2008 scandal that helped spur the new agreement, Chinese drug makers substituted a cheaper fake ingredient in the blood thinning drug heparin, an action linked to 81 deaths.
Generic drug companies also stand to win faster approval of new drugs, a process that now can take two and one-half years, according to The Wall Street Journal. The new agreement is expected to lead to the hiring of new reviewers, enabling the FDA to reduce the backlog of drug approval applications.
The provisions for more foreign inspections, however, will not cover brand-name prescription medications. Neither will it cover over-the-counter medicines or vitamins, whose global supply chains, the Times said, are even more vulnerable to tampering because they almost never are visited by government inspectors.
