Originally Published
MX July/August 2002
BUSINESS NEWS
Device Industry Has Close Encounter with User Fees
User fees for the
medical device industry have been a topic of heated debate for more than a decade.
But in May, with little public fanfare, adoption of user fees nearly became
a done deal.
After a behind-the-scenes
conference among members of Congress, representatives of industry trade association
AdvaMed (Washington, DC), and FDA, a user-fee provision entitled the "Medical
Technology Enhancement Act of 2002" was scheduled for inclusion in the
Public Health Security and Bioterrorism Preparedness and Response Act, which
was then coming up for a vote in the House of Representatives. The provisions
of the bill combined counter-bioterrorism measures and renewal of the Prescription
Drug User Fee Act (PDUFA), which was first enacted in 1992.
In the end, the
device user-fee proposal died without being incorporated into the bioterrorism
preparedness act. Congress later passed the act—including its PDUFA provisions—and
President Bush signed the legislation on June 12.
After the House
vote, which occurred a day before the start of the annual meeting of the Medical
Device Manufacturers Association (MDMA; Washington, DC), MDMA president Larry
R. Holden said he expected all parties—Congress, FDA, and both device industry
trade associations—to take up the matter again soon, in a more open forum.
"Our hope is that they will include us in the process going forward, and
that the voice of the small manufacturer will be heard."
In an address at
the MDMA meeting, Sen. Orrin G. Hatch (R–UT) cautioned manufacturers that
user fees for medical device manufacturers will be revisited—more than
likely this year.
"That is the
reality." said Hatch." I do not want to place a burden on the small
medical device manufacturer. However, you need to figure out what you can support,
and get that message to Capitol Hill—the sooner, the better."
According to AdvaMed
president Pamela Bailey, the need to support FDA makes the adoption of user
fees a near-term likelihood. "Lawmakers on both sides of the aisle clearly
understand the need to increase FDA resources and strengthen review tools to
prepare it for rapid advances in medical technology," she noted.
With the recently negotiated user-fee agreement benefiting from support in both the House and Senate, Holden acknowledged that some compromise may be required. "But we have to make sure the small manufacturers are protected," he cautioned.
Copyright ©2002 MX
