Wright Medical Group, Inc.’s road for reaching FDA approval for its PMA (premarket application) for Augment Bone Graft has been rocky and highlighted by a contentious FDA orthopedic panel meeting in 2011.
On August 8, 2013, the company received an 18-page “not approvable” letter from the FDA for the product. The FDA said it was “concerned that the population enrolled was predominately low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.”
But on March 10, 2014, the company announced it has reached an agreement with the FDA’s Office of Device Evaluation (ODE) under which ODE will accept a further amendment to the PMA for the bone graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31, 2014, will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE, according to the company announcement, has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvability determination.
Robert Palmisano, Wright’s president and CEO, said while the development is cause for somewhat greater optimism than the company has thus far had reason to embrace, “It is important to reiterate that the parties’ positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination.”
The agency had said the company would have to perform a new clinical study that evaluates the product as substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high risk target population. The agency specifically had concerns about the “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.”
Contentious FDA Panel Meeting
At an FDA panel meeting in May 2011, panel member Brent Blumenstein, Ph.D., a statistical consultant said, “The [clinical] trial has no meaning.” Augment was then owned by BioMimetic Therapeutics Inc. However, the final panel vote was 12-6 in favor of approving Augment as a safe treatment for ankle surgery after a rare public rebuke by panel members of FDA staff for failing to present safety evidence for the company’s dental product. Panel members said they thought the agency came to the meeting with an agenda.
The panel then went on to vote 10-8 that Augment for ankle fusion surgery was effective and, finally, voted 10-8 that the product when used by surgeons in hindfoot and ankle surgery, delivered benefits that outweighed the risks.
Wright paid $380 million for BioMimetic in 2013.
