A proposed joint venture between Food & Drug Administration and Centers for Medicare and Medicaid officials for reviewing medical devices is drawing mixed reviews from industry officials.
“We’re still reviewing the details,” said Abbott Medical Optics senior vice president James Mazzo. “We believe it’s important to preserve the currently separate and distinct regulatory missions of both of those factions.”
Mazzo, who is also chairman of the Advanced Medical Technology Assn., was speaking to a gathering of press at the trade association’s annual conference in Washington, D.C., this week.
In September, the Food & Drug Administration and the Centers for Medicare and Medicaid opened up their plans for concurrent evaluations of pre-market, FDA-regulated medical products to public comment.
The two agencies said that the collaboration, known as “parallel review,” would promote data-sharing between the two organizations and reduce the time it takes to get devices to market. That’s because it would allow CMS to make its national coverage determination while the product is still under FDA review.
A memorandum of understanding between the two largest regulatory bodies in medicine was signed June 23.
FDA commissioner Dr. Margaret Hamburg said earlier in the day that the process would help “eliminate barriers that may hinder medical devices that would address unmet needs.”
But industry officials are concerned that the increased collaboration could have other side effects, such as reimbursement coverage decisions influencing whether or not a device makes it through the approval process.
AdvaMed president Stephen Ubl called the policy “well-intentioned,” because frequently companies experience a lag between FDA approval and national coverage determination. But Ubl expressed concern over the scope of the mission and the notion that the agencies might be biting off more than they can chew.
“There’s an awful lot going on at FDA and CMS and I don’t think it would be in anyone’s best interest to tackle too much integration between the two entities at a time when they’re both going through substantial reform in their own right,” he said.
Mazzo added that the industry council was in favor of anything that could improve “timeliness, predictability and efficiency.”
Comments on the proposal can be submitted electronically at regulations.gov.
