FDA, Medical Device Makers Reach Agreement on User Fee Plan
Medical device makers said yesterday that they have reached an agreement with the FDA that would allow the agency to assess user fees to speed the review process for new products, the Wall Street Journal reports. Similar to the fees the agency charges pharmaceutical companies, the plan -- negotiated with the Advanced Medical Technology Association, an industry trade group -- would provide the agency with additional resources to increase the staff of the FDA's device program, which has decreased 10% since 1995 (Adams, Wall Street Journal, 5/21). "The device center has been facing the perfect storm of declining resources and a flat budget over the past 10 years, as well as a loss in review staff," Steve Ubl, a lobbyist for AdvaMed, said, adding, "On the other hand, they've faced a rising tide of innovation, more device applications and more complex applications." The agreement would provide the FDA with $225 million over five years. Of that, user fees would account for $150 million, and congressional appropriations would total $75 million. Device makers would pay about $125,000 for an expedited review of a new device. The plan also would require the FDA to create an office to handle "combination products" and to permit electronic labeling and registration (Fulton, CongressDaily, 5/20). The Journal reports that HHS, the White House Office of Management and Budget and Congress must approve the deal (Wall Street Journal, 5/21). Lawmakers will decide "in the next day or so" whether to include the plan in bioterrorism legislation that Congress intends to pass before the Memorial Day Recess. The agreement is modeled on the Prescription Drug User Fee Act, which is also expected to be included in the bioterrorism bill.
The proposal is not without controversy, as smaller device firms are "concerned about the concept" of user fees. While the agreement would allow firms that make less than $5 million a year to defer user fee payments for a year or more, Larry Holden, president of the Medical Device Manufacturers Association, which represents smaller firms, said they have "very strong reservations" about the plan (CongressDaily, 5/20). The Journal reports that some in Congress share these concerns, saying the plan "tilts toward the interest of big device makers at the expense of smaller ones." Congressional officials also are concerned that user fees would "bin[d] the agency's hands too tightly." The FDA's prescription drug user fee program has generated similar concerns; critics say the program has led the agency to "rus[h] to judgement" on new drugs. Although FDA officials say they are careful during the review process, they do "concede" that "user-fee imposed pressures" have made the review process more difficult, the Journal reports (Wall Street Journal, 5/21).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.