CRANBURY, N.J. – Able Laboratories Inc. (www.ablelabs.com), which in July had filed Chapter 11 bankruptcy in hopes of restructuring while it worked with the Food and Drug Administration (FDA; www.fda.gov) to settle regulatory issues that led to the recall of its products and suspension of all manufacturing operations, has decided instead to sell the business and its assets to one or more third-party purchasers.

The company had been a developer and manufacturer of generic pharmaceuticals.

On behalf of the company, Senior Vice President/Chief Scientific Officer Dr. Garth Boehm had proposed a consent decree to the FDA that would have permitted it to revalidate the product development data included in the company’s previously approved Abbreviated New Drug Applications (ANDA), under new management, and with the data being verified by an independent outside consultant.

Since Able suspended operation of its entire product line in May, the company has not generated income or revenue. To speed up the possible return to production, Able proposed that it relaunch its generic products under ANDA, upon completion of the revalidation work, without the need for full FDA review and approval of all of the data supporting each ANDA. The proposal represented a departure from long-standing FDA policy in situations involving questions of data integrity, but Able felt the proposal was justified based on its voluntary actions to recall products and cease manufacturing.

After careful consideration, however, the FDA declined the proposal, arguing that the relaunch of products would require withdrawal, resubmission with new data, and agency review of ANDAs for products Able intended to manufacture-a process that could take up to 18 months for each case.

In a printed statement, company officials said, “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 a reorganization is not feasible.”

In early July, the FDA presented a Form 483 to Dr. Boehm, citing 12 observations based on inspections conducted May 2 through July 1 that led to the voluntary recall and manufacturing cessation, including:

• Products that failed to meet established standards, specifications and quality control criteria were not rejected. (“Samples of drug products were routinely resampled, and reinjected or reprocessed in the Waters, Empower Data Acquisition System during testing…when out of specification [OOS] were obtained.”)
• An NDA (New Drug Application) Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
• Laboratory records failed to include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards.
• No written records of investigations into unexplained discrepancies and the failure of a batch, or any of its components, to meet specifications.
• Employees were not given training in cGMPs and written procedures required by cGMP regulations.
• Established laboratory control mechanisms were not followed.
• Control procedures were not established to validate performance of manufacturing processes that could be responsible for causing variability in the characteristics of in-process material and the drug product.

In a written reply to District Director Douglas Ellsworth, Dr. Boehm said, “Able believes that the best path to restore the confidence of the agency, the users of Able products, and the public at large, is through a consent decree of permanent injunction,” which would provide an FDA-sanctioned, court-supervised means for the company to address the observations, improve quality systems and controls, and eventually reintroduce products to the market.

“Given our proposal to proceed under a decree,” Dr. Boehm wrote, “we do not intend to submit a written response to the Form 483. This intent, however, should not be interpreted that the company admits any violation of law or regulations.”

In light of the FDA’s final decision, and the need for the company to reduce expenses, Paul Cottone, Able’s chief restructuring officer, has resigned but will continue to assist the company on a consulting basis.