In fact, the FDA can’t come close to conducting regular safety inspections of overseas facilities making meds and bulk ingredients imported into the US. Steven Solomon, deputy director of the FDA’s Office of Regulatory Affairs, told a House Energy and Commerce subcommittee yesterday the agency can only inspect “several hundred” foreign facilities a year - out of almost 3,000 - because of a shortage of staff and resources.

And FDA Deputy Commissioner Randy Lutter told the panel that pharmaceutical operations in the US are supposed to be inspected every two years to ensure good manufacturing and safety practices, but the agency doesn’t have enough inspectors to come anywhere near that goal overseas. In response to a question, Lutter confirmed some companies exporting meds to the US haven’t been inspected by regulators for as long as 10 years. Lutter also acknowledged the FDA does not have any inspectors permanently in China…

…which along with India has a rapidly expanding drug industry. China recently proposed reforms of its drug laws, but has experienced serious safety problems and recently executed the head of its drug regulatory agency on charges of corruption, reports The Star-Ledger of New Jersey (which owns Pharmalot).

The FDA’s comments came during a hearing on legislation sponsored by Reps. John Dingell (D-Mich.) and Frank Pallone (D-6th Dist.) that would create a user-fee system for imported drug and food shipments to fund additional personnel for inspections at U.S. borders and at manufacturing plants abroad.

The money also would be used by FDA laboratories to improve analysis of food and drug imports and to test import samples and research new testing techniques. In addition, the legislation would authorize the FDA to issue mandatory product recalls; require country-of-origin labeling for food, drugs and medical devices; restrict food imports to ports with an FDA testing laboratory; and set up new food safety standards.

Dingell said the “FDA’s underfunded import safety system is equivalent to holes in a block of Swiss cheese.”

Pallone said the failure of the FDA’s import safety system has sparked fear and caused a lack of consumer confidence. American consumers should be able to trust that the products they purchase have been properly regulated and inspected, thereby making them safe.”

The legislative proposal comes amid growing concern fueled by recent headlines about tainted produce, pet food, fish and toothpaste imported from China. The FDA inspects less than 1 percent of the estimated 16.3 million shipments of food, drugs, medical devices, cosmetics and other products it regulates that come across the borders and into American ports from more than 230 countries. The volume of FDA regulated imports has doubled in the last five years.

An estimated four of 10 prescription drugs sold in the United States are manufactured abroad, and about 80 percent of the active pharmaceutical ingredients used by U.S. manufacturers to make prescription drugs are imported.

Alan Goldhammer, deputy vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said drugmakers have their own controls to ensure purity and potency of medicines through the drug development and distribution process. “Quality assurance is an ongoing part of the business; it does not stop when the new drug application is approved and production commences,” he said.

Goldhammer acknowledged there are “loopholes” in the system that can result in the distribution of counterfeit medicines. He urged tougher requirements for companies that repackage medicines, closer oversight of wholesalers, and increased criminal penalties for counterfeiting activities. But he wouldn’t comment directly on the pending legislation or proposed user-fees, but a spokesman for the drug industry trade group said the issues are “still being reviewed and discussed and a final position has not been reached.”

The food industry said it opposes user-fees, and believes a voluntary quality-control system spearheaded by the industry in cooperation with the FDA would enhance imported food safety. “We strongly oppose the user-fee provision,” said Cal Dooley, president of the Grocery Manufacturers/Food Products Association, adding that the fees would “impose significant financial burdens on companies,” place an unfair cost on importers and violate trade agreements.