Device Industry Has Close Encounter with User Fees

Originally Published MX July/August 2002

BUSINESS NEWS

Device Industry Has Close Encounter with User Fees

Erik Swain

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