Able was forced to cease manufacturing and recall all of its products in May after serious questions were raised about quality control data used to obtain approval for products made at its manufacturing facility in New Jersey. The company has been in negotiations with the US Food and Drug Administration (FDA) for a 'rescue package' that would allow it to start making and selling products again. But these have failed, according to a company statement released yesterday.
Able proposed to the FDA that it be allowed to re-validate the product development data included in the company's previously approved Abbreviated New Drug Applications, under new management and with the data being verified by an independent outside consultant. This would have allowed it to relaunch products without a need for full FDA review and approval of all of the data supporting each ANDA.
But while it was a bold strategy, it required a departure from long-standing FDA policy in situations involving questions of data integrity, and the FDA declined the proposal.
The agency said Able's only route back to market was to withdraw and resubmit ANDAs - with new data - for the FDA's review. Able estimates that this could have taken up to 18 months for each case, and has had to conclude that this delay would be too long and costly for the company's precarious finances to bear.
A month ago, Able filed for bankruptcy protection while it tried to carry out a reorganisation of its business, but as it is now unable to produce any revenue or cash flow for a significant period of time, a reorganisation is simply not feasible.
"Able has determined that the best course of action to preserve value for its creditors and others would be to immediately reduce overhead and expenses as much as possible and to initiate the process of selling the company's business and assets to one or more third-party purchasers," it said.
In light of the decision, Paul Cottone, the company's chief restructuring officer, had resigned. Richard Shepperd, the company's director of restructuring, will continue with the company's efforts to reduce expenses and to market assets.