FDA Analyzing Non-Inspected Foreign Firms Which Are Named in NDAs

FDA's next step in analyzing data from the Operational and Administrative System for Import Support will be to identify non-inspected foreign drug firms referenced in approved human or animal drug applications.

The data will then be used to prioritize the foreign manufacturers for scheduling of inspections, FDA Commissioner Henney testified before a House Commerce/Oversight Subcommittee hearing on bulk drug imports Oct. 3.

"The human drug firms will be evaluated using a risk-based analysis stratified into one of four tiers, incorporated into FDA's surveillance list and subsequently scheduled for inspection," Henney said.

FDA has identified 242 foreign manufacturers of active pharmaceutical ingredients that have exported to the U.S. but who have not been inspected, Henney reported. "The agency is developing an import alert for these uninspected foreign drug establishments," she continued. Forty-six of the identified firms are in China and Hong Kong and 11 are in India.

At a Commerce Committee hearing on June 8, a report based on data from OASIS estimated the number of non-inspected foreign manufacturers at 4,600 (¹ (Also see "Bulk Drug Import Quality Reports May Be Required From U.S. Firms" - Pink Sheet, 12 Jun, 2000.)).

"FDA has reviewed the OASIS data and manually cross-checked it with other information sources to weed out duplicates and incorrect entries and establish a much more accurate list of uninspected foreign drug manufacturers," Henney said.

Henney provided an update on five initiatives announced at the June hearing to detect counterfeit and substandard APIs.

An FDA proposal to require domestic manufacturers to inform FDA if they receive substandard bulk materials from the approved source is in development, but not imminent, Henney indicated.

"FDA is examining what would be required to develop a proposed regulation that would establish this requirement," she said. "We need to engage in a very thorough discussion and dialogue with industry," Henney explained. "Notice and comment rulemaking could take us several months."

FDA has allocated additional funds for the Forensic Chemistry Center. The increased funding was used to conduct 20 targeted active pharmaceutical ingredient inspections, including nine at importers of foreign APIs, 10 at domestic finished dosage manufacturers and one at a domestic animal drug manufacturer.

FDA expects to have the Forensic Chemistry Center database available to all field inspectors by January. The database contains information on 330 active pharmaceutical ingredients "which FDA can use to more quickly identify whether or not a product is authentic or counterfeit," Henney said.

A pilot program begun in Philadelphia in 1997 to provide drug approval information to import field personnel will be expanded to the rest of the country by the end of the year, Henney said.

Finally, the agency has "placed the import industry on notice regarding the existing requirement to provide FDA with accurate data regarding the identity and location of imported drugs."

Henney suggested that the agency's foreign inspection program might not draw as much criticism if legislators provided sufficient appropriations.

"The agency has long recognized we need additional resources in the area of postmarketing surveillance," Henney testified. Funding of those activities could be used to conduct foreign inspections and "increase the surveillance of foreign APIs and finished drugs."

Henney noted that in FY 1999 and FY 2000, "the President's budget included $25.8 mil. and $39.3 mil., respectively, for postmarketing surveillance activities, none of which was funded." The Clinton Administration's request for FY 2001 includes $45 mil. for postmarketing surveillance efforts. One of FDA's primary goals during the Prescription Drug User Fee Act reauthorization process is to make the case for increased funding for postmarketing surveillance (² ).

The hearing occurred during the final negotiations over legislation to allow reimportation of pharmaceuticals. One of the witnesses was a Lilly quality control executive, who suggested that the pending changes could make bulk drug counterfeiting more of a problem (³ (Also see "Rx Import Bill Undercuts FDA Approach To Quality Control, Lilly Exec Testifies" - Pink Sheet, 9 Oct, 2000.)).