Nature Medicine | Spoonful of Medicine

FDA needs to export know-how to import safer drugs, reports says

The US Food and Drug Administration must share more safety inspection and training responsibilities with regulators in other developed countries, says a new report published today by the independent, non-governmental US Institute of Medicine (IOM) in Washington, DC. The report calls on the FDA, for example, to collaborate with its European counterparts on the gathering of inspection information related to manufacturing facilities overseas. Among the other 13 recommendations in the report, it also advises that the FDA partner with agencies abroad to help train regulators in nations such as India and China, where drugs are increasingly manufactured for the international market.

“If you look at the magnitude of drugs, the number of manufacturers and the complexity of the supply chains, there’s just no way one agency can do it alone,” says Jim Riviere, a pharmacologist at North Carolina State University in Raleigh and the report’s lead author. “This requires a broad, international collaboration. It’s impossible to inspect our way out of this alone or at the border.”

Recent cases of drug contamination, spoilage and counterfeiting highlight the need for such reforms. In 2007 and 2008 more than 80 people died in the US after being given contaminated doses of the blood thinner heparin, the active ingredient of which had been manufactured in China. And just this week, the FDA said that counterfeit versions of the cancer drug Avastin that originated in countries including Turkey and Egypt continue to be illegally marketed to US consumers.

To prevent such lapses in the future, according to the report, the FDA will need to collaborate with regulatory bodies in Europe and other developed countries to create a standardized and widely available international curriculum. “There’s not an enormous tradition of regulators cooperating together,” says committee member Thomas Bollyky, a senior fellow at the Council on Foreign Relations in Washington, DC. “But to get the kind of action you need, you need all those participants involved. It’s really in everyone’s best interest.”

Beyond urging global outreach by the FDA, the report emphasizes that responsibility for ensuring drug safety also falls on importers in US.  “It’s important to hold companies liable for what happens in the supply chain,” says Bollyky, who says the FDA should pursue both litigation and incentives for companies to monitor their own pipelines more carefully.

The report, which was commissioned by the FDA, will also inform the spending decisions of the agency’s new deputy commissioner for global regulatory operations and policy, a position created in July 2011 to oversee the global food and drug markets. One of the first actions by the deputy’s office has been to champion a law expected to pass this summer that will raise approximately $300 million per year from generic drug makers for surveillance of overseas drug manufacturing plants. The recommendations in today’s IOM report will be the foremost tool in determining exactly how that money is spent. “This is not a simple issue of putting more [FDA] boots on the ground in one or two countries,” says Riviere. “They have to use both carrot and stick policies.”

Photo courtesy of the Institute of Medicine


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