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  1. Pharmaceutical Quality Resources

Court decision strengthens FDA's regulatory power

FDA Consumer, Sept, 1993 by Dixie Farley

 

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 deficiencies reported by FDA investigators reviewing Barr's practices and products during inspections. The reported problems include misplaced records, test data recorded on scrap paper, failure to control manufacturing steps such as those governing products' physical properties, release of products not meeting their specifications, inadequate investigation of failed products, and failure to validate test methods and manufacturing processes, including cleaning processes.

On behalf of FDA, the U.S. Attorney's Office had filed suit against Barr and some of its officers on June 12, 1992, to stop the company from manufacturing and distributing drugs FDA alleged to be substandard. FDA also sued to obtain a court-ordered recall of deficient batches of drugs already on the market and to require that Barr improve its manufacturing and laboratory practices. Barr agreed in July 1992 to suspend distribution of two-thirds of its products, which as a result were not covered by the court's decision.

While acknowledging that since the hearing began, Barr had made many of the improvements FDA identified as necessary, Judge Wolin noted that Barr's transformation from an "ugly duckling to a swan" was far from complete. In ordering most of the remedies FDA asked for, Judge Wolin observed that the impetus for the improvements was the pressure from FDA's lawsuit, rather than a change in attitude by Barr. As a result, Judge Wolin decided, these deficiencies would likely recur if there were no court order. The order calls for the court to retain control of the case to ensure Barr's compliance.

Judge Wolin's decision holds that FDA can initiate a recall of defective drugs by applying to a court to enjoin the firm.

Although the Food, Drug, and Cosmetic Act is silent on drug recalls, Judge Wolin found that the court has the inherent power to order a recall of "any product found to be manufactured in violation of the [FD&C] Act that has been released to the public for distribution. . . . Any other rule would allow Barr to use its channels of distribution to shield adulterated products from the Court's remedial arm, thereby frustrating the purpose of the Act."

This opinion also provides scientific and legal guidance to generic and pioneer drug manufacturers about their compliance obligations under the FD&C Act. The opinion discusses topics such as validation studies needed to ensure that a product meets its required specifications, test averaging, retesting, investigation of batches of failed products, and equipment cleaning and record-keeping.