FDA Promises Independent Review for Previously Unapproved Devices

The U.S. Food and Drug Administration has thrown lifelines to two orthopedic device companies this month, offering to provide independent review on devices that were denied approval in the past.

In 2008, San Luis Obispo, Calif.-based FzioMed Inc. was informed by the FDA that its Oxiplex gel for preventing adhesions (peridural fibrosis) was not-approvable. Johnson and Johnson and Medtronic were distributing this product outside the United States at the time, but there was no similar FDA-approved gel approved for sale within the United States. The Orthopaedic & Rehabilitative Devices Panel advising the FDA on the technology believed FzioMed’s statistical method to be exploratory or post-hoc data mining. One surgeon said the data seemed to be manipulated.

In August this year, Arlington, Tenn.-based Wright Medical Technology Inc. found itself facing the nightmare FzioMed faced years ago, receiving a “not-approvable” letter from the FDA for its Augment bone graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The news came as a shock to the company, sending Wright President and CEO Bob Palmisano into crisis-management mode as he regrouped his troops and set a plan in place to figure out why the FDA found their clinical study to be inadequate. FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.”

This month, the regulatory agency has informed both companies that it will convene a Dispute Resolution Panel to provide advice to the agency commissioner on the details of the cases for both devices.

“We appreciate the FDA’s willingness to grant our request to convene a Dispute Resolution Panel in connection with our appeal of the not approvable decision for Augment Bone Graft,” said Wright’s Palmisano. “We look forward to working with the FDA to schedule the panel meeting as soon as possible.”

“We commend the FDA for granting our petition for reconsideration, a rarely used part of the regulatory process that companies can pursue when their device application is denied by the FDA,” said John Krelle, president and chief executive officer of FzioMed, stated in the release. “The totality of data from the various studies submitted to FDA on Oxiplex, representing approximately 500 patients studied over nearly a decade, combined with extensive clinical success achieved outside the United States, demonstrate that Oxiplex can offer increased effectiveness compared to spine surgery alone, while presenting no significant safety risk.”

Arlington, Tenn.-based Wright Medical Technology Inc. makes