The medical device industry’s Washington lobby called for the creation of a special government office with oversight of “major proposed and current government policies to assure that they support medical innovation.”
The Advanced Medical Technology Assn., in its “innovation Pathway” proposal, called for the office to operate out of the White House. The idea is to create a central crossing point for concerns about policy decisions being made across the government. The proposal comes as part of a series of recommendations the industry council is packaging as its competitive agenda for the American medical technology industry.
AdvaMed proposed six recommendations, including reforming the FDA review process to reduce review times, changing payment policies at Medicare and Medicaid to support medical innovation and making changes to the country’s trade and tax policy.
The industry council didn’t mince words when it came to the FDA, saying that the increasing decision times at the watchdog agency have “a devastating impact on the competitiveness of the American medical device industry, as well as on patients.”
AdvaMed called for the agency to measure its metrics on total review time, rather than “FDA days” in measuring its time to approve medical devices for market. The agency currently only measures days that the product is under review by reviewers when reporting metrics to Congress under the medical device user fee agreement.
“Part of the problem is that FDA manages to the wrong metrics,” AdvaMed officials wrote. “What matters to industry and to patients is not time on the FDA clock, it is the total time from the time the product is submitted to FDA for review to the time it is cleared for market. Accordingly, FDA must set a goal of reducing total review times.”
