The FDA and representatives from the medical device industry
have reached an agreement in principle on proposed recommendations for the
third reauthorization of a medical device user fee program.
The recommendations would authorize the FDA to collect $595 million
in user fees over five years, plus adjustments for inflation. Details of the
agreement, such as the fee structure, are expected to be finalized soon.
Under a user fee program, industry agrees to pay fees to
help fund a portion of the FDA’s device review activities while the FDA agrees
to overall performance goals such as reviewing a certain percentage of
applications within a particular time frame.
The agreement in principle is the result of over a year of
negotiations between the FDA and industry. It 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. With the
additional funding, the FDA would be able to hire over 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, M.D. “Reauthorization of this important program is an essential
component for advancing medical device innovation.”
The industry associations who have reached an agreement in
principle 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 (MDUFA I), prompted by growing concerns about the
capacity and performance of the medical device review program. The five-year
program was reauthorized with the Medical Device User Fee
Act of 2007 (MDUFA II) and is set to expire on Sept. 30.
MDUFA II authorized FDA to collect user fees for certain
medical device applications, for the registration of certain medical device
establishments, and for certain other purposes. Small businesses may qualify
for a waiver from fees on certain submissions or may qualify for a reduced fee.
In September 2010, prior to beginning negotiations with
regulated industry, the FDA held a public meeting on the device user fee
program attended by a variety of stakeholders including industry, scientific
and academic experts, health care professionals, and representatives from
patient and consumer advocacy groups. Stakeholders provided their assessment of
the overall performance of the MDUFA program and their opinions about which
aspects of the program should be retained, changed, or discontinued in order to
further strengthen and improve the program.
Once the final details of the agreement with industry is
completed, FDA will develop a package of proposed recommendations and give the
public an opportunity to comment before they are submitted to Congress.
The date of the public meeting has yet to be determined.
For more information:
MDUFA
Meetings
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and other
biological products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation's food supply, cosmetics,
dietary supplements, products that give off electronic radiation, and for
regulating tobacco products.
Posted by Sean Fenske, Editor-in-Chief, MDT