FDA Rejects Able Labs’ Plan To Return Products To Market
This article was originally published in The Pink Sheet Daily
Executive Summary
Able plans to sell its business and assets rather than pursue full resubmission of its ANDAs.
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The most expeditious way for Able Laboratories to return its withdrawn generic drugs to market would be to resubmit the ANDAs to FDA for review with new data, the company reported Aug. 16. FDA rejected Able's return-to-market plan, under which the company proposed re-validating existing product development data included in previously approved ANDAs. Able had been working with FDA to develop a plan to return to normal operations since voluntarily withdrawing all of its products from the market because of data integrity concerns (1 (Also see "Able Labs To Withdraw Seven Approved ANDAs, Recall All Products" - Pink Sheet, 23 May, 2005.)). Able suggested revalidating the data under the direction of new management and verifying it through an independent consultant, the generic drug manufacturer said. "The proposal represented a departure from long-standing FDA policy in situations involving questions of data integrity, which Able felt was justified by its extraordinary voluntary actions," the company said. "Although recognizing the company's actions, the FDA advised that the most expeditious relaunch of products would nevertheless require withdrawal, resubmission (with new data), and agency review of ANDAs for products that Able desired to manufacture in the future." A complete review of the ANDAs, as required by FDA, could take up to 18 months for each application, even if conducted under an expedited approach, Able predicted. As a result, the company announced it will sell its business and assets to one or more third-party purchasers, rather than pursue a plan to resume manufacturing and marketing the drugs on its own. "Because Able's business plan for its reorganization depended on obtaining significant external financing, which in turn was predicated on its being able to return certain products to the market in a more timely manner, it has now determined that the business plan for reorganization is not feasible," the company stated. Able shareholders are unlikely to benefit from the sale since the amount of the liabilities owed to creditors is expected to exceed the proceeds from the sale, the firm added. Able also announced that in connection with its decision, Chief Restructuring Officer Paul Cottone resigned from his post, although the exec will continue to assist the company on a consulting basis. Director of Restructuring Richard Shepperd will continue Able's efforts to reduce expenses and to market assets, the firm reported. An FDA inspectional report found that Able failed to reject drugs that did not meet established standards, specifications and quality control criteria. The company filed for bankruptcy in July. Able previously marketed a range of generic drugs, including equivalents of Tylenol with Codeine (acetaminophen/codeine), Vicodin (hydrocodone), Tenormin (atenolol), Soma (carisprodol), Lomotil (diphenoxylate/atropine) and Lithobid and Eskalith (lithium carbonate). - Jessica Merrill |