ABLE LABORATORIES OFFERS CONSENT DECREE TO FDA
Embattled generic drugmaker Able Laboratories, which in May voluntarily recalled its entire product line because of quality problems, is hoping to restart its operations under a consent decree agreement it has proposed to the FDA.
"Able believes that the best path to restore the confidence of the agency, the users of Able's products and the public at large is through a consent decree of permanent injunction," Garth Boehm, the company's senior vice president and chief scientific officer, wrote in a letter addressed to Douglas Ellsworth, director of the FDA's New Jersey District. The letter was in response to a Form 483 issued to Able following an inspection of the company's Cranbury, N.J., operations, where FDA investigators recently documented 12 inspectional observations.
"The entry of the decree would provide an FDA-sanctioned, court-supervised means for Able to properly address the inspectional observations, improve its quality systems and controls, and, subject to individual FDA authorizations, reintroduce products to the market," the letter adds.
An FDA spokeswoman acknowledged the agency has received Able's consent decree proposal, but she said the agency has not decided how it intends to proceed in the case.
The consent decree proposal comes roughly six weeks after Able, one of the nation's largest generic drugmakers, voluntarily halted its manufacturing operations and recalled its full product line after an internal review of its operations revealed apparent departures from standard operating procedures. Initiated in March after the company was forced to recall several products because of improper manufacturing practices, the internal review identified improper laboratory testing practices and noncompliance with FDA current good manufacturing practices (cGMPs).
Able markets more than 40 FDA-approved products, including generic versions of Abbott Laboratories' Vicodin (acetaminophen/hydrocodone bitartrate), Novartis Pharmaceuticals' Ritalin (methylphenidate HCl) and GlaxoSmithKline's Compazine (prochlorperazine).
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