FDA urged to revise generic drug process

November 16, 1990|By Susan Hansen | Susan Hansen,Washington Bureau of The Sun

WASHINGTON -- A task force set up by the pharmaceutical industry called on the Food and Drug Administration yesterday to revamp the approval process for new generic drugs and beef up enforcement against drug testing fraud to help restore public confidence in the generic drug industry.

The private review board, formed in the wake of revelations two years ago that several generic drug firms had bribed FDA officials and had supplied false information to them to win approval for their products, said they wanted the FDA to guarantee the integrity of the testing process.

"Confidence is a fragile commodity, and credibility is a fragile commodity," said Washington attorney Lewis Engman, chairman of the Blue Ribbon Committee on Generic Medicines. "It has to be earned."

The committee, which included Dr. Andrew Whelton of the Johns Hopkins School of Medicine, focused on steps it said both the government and private manufacturers could take to improve testing procedures.

The committee's report urged the FDA to adopt stricter rules for drug companies and for institutions they hire to test new generic drug products and to require disclosure of financial arrangements other than "standard fee-for-service" between manufacturers and testing labs.

The seven-member panel also called for more precise FDA guidelines for manufacturers on acceptable methods for demonstrating that generic products may be equivalent to brand-name drugs. It also urged the FDA to provide published summaries of the review process for each new generic drug approved, including a description of the rationale for the decision.

Mr. Engman, who emphasized that the panel's review was independent, said he felt confident that the FDA "is now on top of the problem" of generic drug testing.

"Do we think generic drugs are safe?" he asked. "The answer is yes."

The report also urged that Congress grant the FDA additional enforcement authority, including power to impose stiffer criminal and civil monetary penalties and to bar those who violate FDA rules from participating in the development of new drug products.

Still, the committee, which attributed drug screening problems to "the extraordinarily competitive environment" for generic drug makers, stressed that companies themselves must bear the principal burden for ensuring product safety.

FDA spokesman Mike Shaffer said that many of the recommendations were likely "to become a matter of practice over time." He said the FDA had taken steps to provide more guidance to drug manufacturers.

The FDA has inspected 36 manufacturing plants and has recalled about 250 generic drug products since federal investigators uncovered problems.

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