On February 11, 2011, the company doors of Anulex Technologies, Inc. began to close. On this day, they were informed by FDA via a Anulex Warning Letter that there regulatory strategy/execution was severely defective. The company decided early in their history that they could obtain a 510(k) clearance for soft tissue approximation (suture) for procedures such as general and orthopedic surgery. After such a clearance they could proceed and conduct prospective phase III clinical studies for spinal annular repair (as part of a spinal discectomy procedure. This was the real marketing objective) without FDA approval (Investigational Device Exemption). It is clearly understood by most that this is a more specific patient population with a very different goal; to repair a spinal disc to allow continued functioning of that anatomical structure (an anatomical part that is avascular and doesn’t have a significant repair mechanism like skin). In addition, the adverse event profile for such an indication is much more significant (proximity to the cauda equina) than closing a surgical incision. All of these differences should have clearly identified their regulatory strategy as fraught with problems.
Anulex proceeded to recruit numerous clinical sites in the United States. They had recruited hundreds of patients in this randomized clinical study when FDA discovered their strategy (their competitors and others in the spinal products market were also aware of this unfortunate regulatory strategy). Upon issuance of the Warning Letter, FDA practically stated that their clinical data could not be referenced in any future marketing submission (PMA) that would have been required for the spinal indication. Thus, flushing down the toilet years of work (resources and millions of dollars) because numerous mistakes were made in the design and execution of the regulatory strategy. In addition, Anulex was now open to potential legal action by patients and surgeons. Anulex is no longer a functioning company.
Designing and implementing a regulatory strategy requires regulatory, technical and clinical knowledge. This knowledge allows one to design and implement a strategy that gains clearance for a product and a client. The strategy can be aggressive but this does not mean it should be sloppy or full of unpredictability.
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