Authority to Stop Importation

The position Autor fills was created this past July with the express purpose of overseeing FDA’s international regulatory efforts and helping the agency get a handle on the global drug pipeline. She told legislators last month that one of the keys to doing this is for Congress to make FDA less of a paper tiger when it comes to exerting is authority abroad.

“One authority that would be very useful is the ability of FDA to refuse to import products from foreign facilities that have denied FDA officials [access] to come in and inspect them,” Autor said. “It seems common sense that if a company is not a good enough player to let the agency in, those are not the products we want to come to the American consumer. Currently, the law is not clear on that.”

The law currently places the burden on FDA to show something is wrong with the product before it can take the step of barring importation.

“With every other grown-up country that we know of, the regulator has the authority to say, ‘If you want your product to come in, you have to show that it’s good,’” Autor said. “For us, we have to show that it’s bad.”

This means FDA must conduct regular inspections of foreign plants, or arrange for that country’s regulatory officials to do so, and that documentation of the drug be available from the ingredient state to raw processing to distribution. Creating this documentation is very difficult in the current environment, especially in countries that do not have a strong regulatory system of their own, Autor said.

FDA has 13 posts around the world, enabling the agency to do some inspections as well as collaborate with their foreign counterparts. It is unrealistic, however, to expect FDA to be able to inspect every foreign plant necessary with the number of personnel in those countries, according to Autor, who pointed out that  bringing in inspectors from the United States. is not always viable.

For example, in China, while staff from FDA’s China office can freely inspect companies, FDA inspectors need a letter of invitation from the company before they can enter the country and inspect. This makes performing an unannounced inspection almost impossible.

FDA is looking for at least a minimum burden on foreign manufacturers to show the product has been approved and manufactured according to U.S. regulations, Autor said. “This would level the playing field between manufacturers who want to do it right and those that don’t.”

Full Committee Hearing - Securing the Pharmaceutical Supply Chain

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