Court Decision Strengthens FDA's Regulatory Power

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In a landmark regulatory action initiated by FDA, a federal court in New Jersey ordered a major generic drug manufacturer to recall millions of its tablets and other drug products. The court found these products had failed to meet quality requirements.

FDA initiated the action under the Federal Food, Drug, and Cosmetic Act. To take such items off the market in the past, either the involved firm voluntarily recalled the products, or FDA requested courts to order seizure by U.S. marshals --provided the agency could find the products. Now, with this precedent-setting decision, FDA can ask the court to order the responsible firms to recall.

After a long hearing at which five industry experts, an FDA investigator, and several company employees testified, Judge Alfred M. Wolin, U.S. District Judge for the District of New Jersey, issued a 79-page opinion last February in the case of Barr Laboratories, Inc., of Northvale, N.J., and Pomona, N.Y.

The recalled drugs are various analgesics and antibiotics. Listed with the numbers of their recalled batches in parentheses, the products are: * aspirin with codeine 325/60-milligram tablets (1C280DY) * erythromycin delayed-release 250-mg capsules (1F584EV) * erythromycin ethylsuccinate 400-mg tablets (OB259FA) * erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension, 200 mg/600 mg (1H445DQ, 1I445EF) * erythromycin stearate 240-mg tablets (O1013FQ) * erythromycin stearate 500-mg tablets (2A219HJ) * hydrocodone bitartrate with APAP 5 mg/500-mg tablets (1D325CL) * meperidine HCl 50-mg tablets (OB381AO, OB381AT, OB381AW, OB381AV).

The court also ordered Barr to stop distributing 24 of its products that had a history of manufacturing deficiencies until the firm validated their manufacturing processes. Barr must demonstrate to the satisfaction of FDA and the court that these processes will reliably yield drugs conforming to required potency and quality characteristics. Only after Barr does this may it resume the drugs' release.

Barr must also perform validation studies on 15 additional drug products, although these products have not been suspended in the interim. All the validation studies must be completed within one year.

In addition, Barr must immediately put into place a wide range of manufacturing and drug-testing controls and explain any gaps in its validation testing. For example, it must: * document the reason for excluding a batch from testing * investigate the reasons for a failed batch before resampling it for testing again * produce a study to validate that the firm's regular cleaning procedures actually clean its milling machine * identify the cleaning agents used in all its cleaning validation studies * record individual test results, not just averages * base product release on all results, not just averages.

Judge Wolin's decision follows four years of increasingly widespread manufacturing …