Lindsay Morris, Acting Executive Director of MITA

The US Food and Drug Administration (FDA) and members of the medical device community have recently settled on revised terms for the medical device user fee program, which will be implemented at the beginning of the 2013 fiscal year.

Every 5 years, the FDA and representative bodies from the medical device industry—this year, the Medical Imaging & Technology Alliance (MITA), AdvaMed (Advanced Medical Technology Association), and the Medical Device Manufacturers Association (MDMA)—negotiate the terms of the program, which funds the FDA’s efforts in approving new medical devices. This iteration of the program aims for more transparency, increased communication between the FDA and device manufacturers, and accelerating the approval process to benefit both manufacturers and patients.

“Essentially, at this point, we are at an agreement in principle with the FDA, which means it has to get the final stamp of approval from the administration, but it will go to Capitol Hill for approval,” said Lindsay Morris, Acting Executive Director of MITA. “Included are some very important changes to the program. One of the most important changes is the addition of the total time goal. It has also been called the shared outcomes goal. Essentially, this ensures that we’re all on the same page in how we calculate the time that the FDA takes to get a product approved.”

Previously, the agreement was based on what Morris calls a “stop the clock process,” meaning that if there was a question or concern on an approval, the FDA would return to the manufacturer for an answer but not count that toward the total time of approval. This new system calls for the shared outcomes goal, which will give a clearer picture for total approval time.

Another aspect that improves process transparency is the inclusion of a third-party review of the approval time.

“There is the addition of an independent assessment of how the FDA is meeting the benchmarks set out in the agreement,” said Morris. “Typically, in the past, the FDA has [analyzed and presented] the numbers that we look at for the total time that they take for approval. We think that this will be helpful in removing any bias or questions of bias in that process by having an independent assessment done.”

Currently, the agreement is nearing completion. One of the few topics left on the table is the actual fees that manufacturers will have to pay for the approval process. A benchmark has been set for how much the FDA will require during this process—$595 million over 5 years to aid in the employment of 200-plus new full-time staff and about 140 new reviewers—but the fee structure has yet to be established.

And when asked whether this agreement will make it through the final approval process, Morris and MITA agree that this should face little opposition.

“I would say that we feel that this is a fair agreement,” said Morris. “We certainly have every intention of working to ensure that this agreement is the final agreement to come out of the legislative process.”