Even as they export product to the U.S. marketplace, foreign drug manufacturers are dodging inspections from Uncle Sam. Plus, a previously unknown deal struck by a union of federal employees may be partially to blame. That’s the official line coming today from U.S. Rep. Bill Cassidy, R-Baton Rouge. Cassidy’s source was anything but flimsy: She’s actually under the wing of President Barack Obama’s administration.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, mostly discussed the FDA’s ability to move drugs safely from pharmaceutical labs to pharmacies around the country. She said the FDA has already green-lighted 20 new drugs for 2011, just one shy of last year’s total. That’s when Cassidy spoke up before the Energy and Commerce Subcommittee on Health. He asked why foreign drug companies are inspected once every nine years, while their American counterparts are inspected every two years.
Woodcock: “(The inspectors) have a union, and they have agreements about foreign travel and how much you can get people to go and do things overseas.”
Cassidy: “You mean there is a union agreement that is keeping us from being able to inspect foreign manufacturers?”
Woodcock: “Partly. That’s my understanding.”
Cassidy, a practicing physician, said he was “shocked” and “concerned,” especially for his patients. Woodcock said she would “get back” with Cassidy with a “complete explanation” at a later date. After the hearing, Cassidy was still reeling. “It is wrong that American dog food manufacturers are more strictly inspected than foreign drug manufacturers,” he says.
The FDA recently announced new long-term strategies to help ensure the safety of imported pharmaceuticals. Among the initiatives planned are a global coalition of regulators, international data systems, increased focus on risk analytics, and leveraging the efforts of private third-party groups. Commissioner of Food and Drugs Margaret A. Hamburg says global production of FDA-regulated goods has “exploded” over the past 10 years and that the line between foreign and local, with raw materials moving both ways, is becoming thinner. “There has been a perfect storm—more products, more manufacturers, more countries and more access,” Hamburg says. “A dramatic change in strategy must be implemented.”
