The agency also stepped up its foreign inspections with help from a user fee reauthorization law (PL 112-144) that set a goal of inspecting foreign and domestic generic drug manufacturers once every two years, using a risk-based approach. Before the law was passed, the FDA had resources to inspect foreign generic drug manufacturers about once every seven to 13 years, according to the agency.
Two countries of particular interest to the FDA are China and India, the two biggest exporters of drugs to the United States.
In China, the agency has opened three offices with 13 U.S. citizens and five Chinese staffers as part of its outreach to inspect facilities and work with Chinese officials, Hamburg told the Appropriations subcommittee that oversees the FDA’s budget.
Rep. Robert B. Aderholt, chairman of the subcommittee, called for the agency to add more people in the field.
“I think we need to have a little more robust inspection over there. I wouldn’t say there should not be a certain percentage [of FDA staff] in China,” the Alabama Republican said during the March hearing.
Hamburg noted that an additional 17 FDA staff are under consideration for spots in China, and stressed that more inspectors can fly in to help with particular inspections.
The FDA also is increasing its collaboration with India, after Hamburg completed her first official visit there as commissioner earlier this year. While there, she signed a first-ever statement of intent with India’s regulatory counterpart to improve communication, share information and address challenges standing in the way of ensuring product quality.
But that development came after the FDA had prohibited four Indian facilities of generic drugmaker Ranbaxy from producing and distributing drugs in the U.S. market.
In her London speech, Hamburg noted that some people questioned whether the FDA’s actions in India were part of an effort to “target” Indian companies. She also said that some Indian companies said they were challenged by the agency’s increased inspection activities.
Hamburg said all of the agency’s inspections were part of the FDA’s usual regulatory framework and every company providing drugs for the United States must ensure their quality and safety.
“For any company who sells their product in the U.S., we inspect and take appropriate actions, measured against our regulatory standards and requirements,” she said.
Another major challenge the FDA is working to confront is the problem of counterfeit drugs entering the legitimate drug supply chain. Counterfeit drugs can contain too much or too little of an active ingredient, contain no active ingredient at all, cab be contaminated or include undeclared substances.
At a recent House Energy and Commerce Subcommittee on Health hearing, officials from the FDA and the Department of Homeland Security testified that illegal drug supply chains are expanding quickly and often stretch through multiple countries.
Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy, said prosecuting counterfeiters is becoming more difficult as drug supply chains become bigger and more international — and as counterfeiters make more use of the Internet.
“They’re smart, they’re careful and what they’re doing is evil,” Sklamberg said.
The officials also said the penalties for counterfeiting drugs have not been updated since they were enacted in 1938.