Why are Medical Technology User Fees Needed?
The medical device industry has reached agreement with FDA on a medical technology user fee proposal to reduce current review delays and prepare FDA for rapidly emerging innovations in medical technology. This proposal would make possible timely, predictable premarket reviews by providing the agency an additional $40 million in the program's first year-- $25 million from performance fees and $15 million from an increase in appropriations - with the five-year aggregate being approximately $225 million. The medical technology user fee proposal agreed to by industry will enable FDA to deliver timely premarket decisions in an era of rapidly advancing medical technology.
Innovation in medical technology will continue accelerating. Robust research and innovation are fueling a revolution in medical technology. New advances are transforming health care and leading to significant progress in the fight against diseases like diabetes, heart disease and cancer.
Research and development spending by medical technology companies has doubled over the last 10 years, and the number of medical device patents has increased 30 percent.
A growing number of premarket submissions are for breakthrough medical technologies that pose novel review issues, like tissue-engineered products, "hybrid" technologies that combine features of devices, drugs or biologics, and nanotechnology.
FDA review delays for new medical technology are increasing. In fiscal 2001, the average total review time for premarket approval applications rose to 411 days, the longest since Congress passed the FDA Modernization Act of 1997. The statutory review time is 180 days.
Without additional resources, these review delays likely will continue to rise in coming years as FDA faces a growing number of novel medical technologies.
FDA lacks the resources and expertise it needs to deliver timely, predictable device reviews.Over the last few years, AdvaMed and many other experts have raised serious concerns over FDA's lack of adequate funds and expertise to review new medical technologies. While the pharmaceutical and biologic review budgets have grown and review times fallen through user fees for these products, the Center for Devices and Radiological Health (CDRH) has lagged behind. In fact, CDRH's actual budget has remained essentially flat over the last 10 years, and staffing levels have fallen by 10% at a time when the volume of work facing the agency is expected to continue to grow substantially.
In addition, FDA is struggling to maintain a strong science base in its device review program. The review program lost 21 scientific and medical officers last year and hired only 15 replacements.
Federal spending constraints and new demands on FDA like bioterrorism preparedness make the prospects bleak for additional funding increases for premarket review. The Administrations budget proposal for 2003 would provide no additional funds for device review.
A subcommittee of FDA's Science Advisory Board reported recently that rapid changes in medical technology threaten to overwhelm FDA's limited review resources, stating that the agency will be "significantly challenged" by "new products arising out of the biological revolution and with breakthrough technologies which will be increasingly complex."
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