Dingell bill would give FDA teeth to prevent fraudulent drug applications

Drug Store News, June 18, 1990

Dingell bill would give FDA teeth to prevent fradulent drug applications

WASHINGTON -- Drug manufacturers who submit false information to the Food and Drug Administration (FDA) could face a three-year minimum "debarment" from future drug approvals under Rep. John Dingell's (D-Mich.) new legislative response to the generic drug scandal.

Dingell uncorked his new Emergency Food and Drug Act of 1990 in the wake of investigations into the generic drug industry that have lead to 13 criminal convictions thus far. Describing the bill as an effort to "clean up the troubled generic drug industry," Dingell said that the measure will provide the FDA with the power to "debar" or "refuse to accept, review or approve" generic drug applications from firms implicated in subverting the drug approval process.

The bill also calls for the suspension of sales of existing drugs from companies engaging in corrupt practices until they can provide "proof" to the agency that their other drug applications are "not tainted."

According to Dingell, five of the 10 leading generic drug manufacturers are guilty of falsifying information and upwards of 100 products have been recalled or withdrawn from the market. While many of the generic firms entangled in this investigation undoubtedly oppose the bill, Dingell expects "support from a majority of generic firms who recognize the importance of cleaning up the industry once and for all."

Rep. Thomas Bliley (R-Va.), one of the bill's 35 original co-sponsores from both sides of the aisle, contends that the generic drug industry "more than most industries, is a creature of the Congress." Citing the 1984 Hatch-Waxman law as the jumping off point for the generic drug industry's success, Bliley asserts that the "abuses" within the industry are a "direct result of the abbreviated product approval process unique to generic drugs."

Sanctions sought

The "FDA currently lacks the sufficient administrative sanctions to deter this scandalous conduct," Bliley said. "The bill provides FDA with the tools of debarment, civil money penalties and the authority to withdraw certain generic drug approvals," he added.

The proposed legislation also attempts to rectify many of the current abuses in the system by restoring the authority of the Inspector General of the Department of Health and Human Services to conduct investigations into FDA complaints. Despite opposition from the Justice Department, Bliley contends that the Inspector General's "resources should continue to be brought to bear on these types of cases" in light of FDA's personnel shortages.