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Appeals Court Cites FDA For Delaying Over-The-Counter Drug Study

May 5, 1987

WASHINGTON (AP) _ The Food and Drug Administration may be unlawfully delaying the completion of its study to determine the safety and effectiveness of over-the-counter drugs, an appeals court ruled Tuesday.

The U.S. Circuit Court of Appeals here ordered a district judge to determine whether the FDA has taken too long to finish the study of the safety and effectiveness of over-the-counter drugs it began in 1972.

The FDA has said it won’t enforce a 1962 law on the effectiveness of over- the-counter drugs until the study is completed.

While not ruling on the merits of the claim, the appeals court suggested that FDA had taken too long to complete the review.

″Once FDA elected to respond to its legislative directive by establishing the OTC drug review program, the APA (Administrative Procedures Act) imposed an obligation to proceed with reasonable dispatch,″ the court said in an opinion by Judge Spotswood Robinson.

″In 1962, Congress ordained that only those drugs generally recognized as safe and effective could be marketed without premarketing clearance,″ the court said. ″Because, a quarter-century later, this mandate has not yet been fully satisfied, close scrutiny must be paid to appellants’ claim that FDA has unreasonably delayed its completion of the OTC drug review program.″

The court sent the case back to U.S. District Judge Thomas Penfield Jackson with a suggestion that he consider imposing ″a binding timetable upon FDA for completion of the program.″

It further instructed Jackson to consider ″the extent to which delay may be undermining the statutory scheme, either by frustrating the statutory goal or by creating a situation in which the agency ’is losing its ability to effectively regulate at all.‴

FDA’s decision not to begin enforcement until all studies are completed ″is relevant to the question of unreasonable delay,″ the court said.

The ruling was made on the 1981 lawsuit by Mimi Cutler and Stephen D. Annard, two members of Public Citizen, a consumer group founded by Ralph Nader. The National Council of Senior Citizens was also a plaintiff.

FDA spokesman Ed Nida declined to comment on the decision, saying he had not read it. The agency began the study in 1972 after a National Academy of Sciences study found that only 25 percent of the 420 drugs studied were effective.

Public Citizen attorney William B. Schultz said the decision means that FDA ″is required to review all over the counter drugs for safety and efficacy.″

″They have to do it and they have to do it in a reasonable period of time. The question is whether the 25-year period is unreasonable.″

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