FDA unfit to handle problem it helped create: Tainted drugs from overseas

Still reeling over the public health threat posed by tainted Heparin imported from China in 2008, in which 140 people died, the FDA’s acting Principal Deputy Commissioner Dr. John Taylor announced Monday that the agency is unprepared to handle similar threats from imported food and drugs. Dr. Taylor believes that without major FDA reforms, similar events will probably occur again. Currently, 40 percent of the drugs consumed in the U.S. and 80 percent of their ingredients come from other countries, while food imports have been increasing by ten percent each year for the past seven years. He also points out that the FDA’s limited ability to regulate these importations is leading to the entry of more counterfeit drugs into the U.S.

To address these challenges, Dr. Taylor announced plans for a new FDA “global strategy and action plan” that includes the formation of a global regulatory coalition through partnerships with the agency’s foreign counterparts and collaborations with the private sector. “Regulators cannot do it alone,” he says.

ACSH's Dr. Josh Bloom cannot resist pointing out the irony of the FDA’s warning in light of the agency’s increasing trend towards more stringent pharmaceutical regulations. “The FDA appears to be complaining about drug manufacturers moving overseas, yet they were the ones who, in part, drove them there — and now they want the help of the pharmaceutical companies! Unreal.”

The issue of counterfeit drugs is something ACSH has known about for a while,” says ACSH's Dr. Gilbert Ross. “This is a big problem in the third-world and to a lesser extent in Europe and here, but it is increasing.”