FDA Says Its Earlier Estimate On Inspections Was Too Low

Thu. May 1, 2008


FDA's drug center director amended her assessment upward today for how much money the agency would need to inspect foreign and domestic drug manufacturers every two years. FDA's Janet Woodcock told House Energy and Commerce Health Subcommittee members that the $325 million estimate she offered Tuesday did not include information technology improvements necessary to identify companies that need inspection. That upgrade, she said, would cost $20 million annually, while "tens of millions [of dollars] for a number of years" more are needed to develop technology compatible with U.S. Customs and Border Protection databases. Furthermore, FDA needs to develop an electronic drug registration and tracking system that would cost $10 million, Woodcock said.

Panel members are crafting legislation that would require drug manufacturer inspections every other year as they seek more resources and authority for FDA to adequately secure all products under its purview. Woodcock stressed today, however, they should consider a risk-based inspection approach. "We believe it would be best for FDA to have the flexibility preserved to put our resources, whatever they are, against the highest risk," she said. House Energy and Commerce Chairman John Dingell was skeptical. "I am concerned risk-based has become a code for, 'We don't have adequate resources for proper oversight,' " Dingell said.

Subcommittee members focused much of the hearing on drug track-and-trace efforts as they consider including a so-called pedigree standard in the safety overhaul legislation in draft form. FDA's top supply chain expert told lawmakers that the agency supports a national track-and-trace standard for drugs and would like any legislation to streamline FDA's ability to destroy dangerous drugs. According to Ilisa Bernstein, FDA's director of pharmacy affairs, potentially counterfeit or unsafe drugs are either returned to the sender or sent to sit on a shelf for 90 days before FDA can destroy them. FDA staff has not yet reached an opinion on the leading pedigree bill introduced recently by Reps. Steve Buyer, R-Ind., and Jim Matheson, D-Utah, Bernstein said. The subcommittee plans to also hold a hearing on medical device and cosmetics provisions in the draft legislation. The hearing today on drugs follows a previous hearing focused on language regarding food safety.

by Anna Edney

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