By James Walsh, Star Tribune (Minneapolis) –
MINNEAPOLIS — After a year of negotiations, the U.S. Food and Drug Administration and representatives of the medical device industry have reached an agreement in principle regarding the medical device user fee program.
The two sides have agreed on proposed recommendations authorizing the FDA to collect $595 million in user fees — plus adjustments for inflation — over five years. Details of the agreement, such as the fee structure, are expected to be finalized soon, the FDA announced Wednesday.
It is the third reauthorization of a medical device user fee program, under which the industry agrees to pay fees to help fund a portion of the FDA’s device review process. In return, the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.
According to the FDA, the agreement “strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.”
The FDA says the additional funding would allow it to hire more than 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.
“I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees,” said FDA Commissioner Margaret A. Hamburg. “Reauthorization of this important program is an essential component for advancing medical device innovation.”
The industry associations that hammered out the agreement with the FDA include the Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance.
Congress first established the user fee program 10 years ago with the Medical Device User Fee and Modernization Act of 2002. The program was prompted by concerns regarding the medical device review program. The five-year program was reauthorized with the Medical Device User Fee Act of 2007 and is set to expire on Sept. 30.