Its rare when a federal agency hearing is marked by all-around praise of proposed regulations that would affect both an industrys and the federal governments bottom lines. That was the case, however, at a Food and Drug Administration public meeting last month to review recommended changes to the Medical Device User Fee and Modernization Act of 2002.
The proposed changes experienced an equally smooth journey through the Senate earlier this month when lawmakers voted to pass them as a part of the Senates FDA Revitalization Acta bill that seeks to renew funding for FDA programs. A House version of the bill is expected to be crafted and voted on by July.
According to those who participated in or observed development of the proposalknown as MDUFMA IIit represents an arduously negotiated compromise that addresses the FDAs budget concerns and the financial limitations of small device manufacturers. Its also designed to streamline and bring more predictability to the pre-market review processsomething both large and small devicemakers have been calling for.
I represent a lot of companies with novel devices that tell story after story of waiting around years to find out what (FDA) department will review its device, says Kelly Slone, director of the National Venture Capital Associations medical industry group. The money spent during that time can add up to millions of dollars.
MDUFMA reauthorization achieves many of the goals both the FDA and the industry are seeking, said Andrew Whitman, vice president of the Medical Imaging and Technology Alliance, a group that represents imaging device manufacturers, during his presentation at the FDA hearing. It provides stable funding for the FDA and reasonable costs to the manufacturers.
Enacted five years ago, MDUFMA was designed to help fund the FDA review process for new medical devices. The money comes from user fees and other assessments on manufacturers. But in the years since the laws inception, few have been satisfied with its regulations, including FDA officials, who have been unhappy with the acts insufficient funding stream.
Our funding hasnt really kept pace with our costs, said Jeffrey Shuren, a physician and the FDAs assistant commissioner for policy, during the April hearing at the FDAs Silver Spring, Md., campus. One of the problems we found is user fees are attached to (pre-market) applications, and the number of applications can fluctuate, so were never sure from year to year what our funding will be.
On the flip side, devicemakers have disliked MDUFMAs unstable application fees, which previously have been increased by the FDA using a varied formula when funding shortfalls occurred, and the unpredictable timeline of the review process. In some instances, weve seen areas in which the FDA did improve its time on reviewing devices, says Mark Leahey, executive director at the Medical Device Manufacturers Association, which represents small manufacturers. On the other side, for the more high-risk devices (such as implants), its taking longer to review those.
FDA officials have said lack of funding has prevented them from hiring the staff needed to speed the review process and make the agency more efficient in handling device questions and concerns. As a result, the agency has looked to increase manufacturers fees to cover the cost of upgrading the review process.
Manufacturers, however, have maintained that their fees should make up only a fraction of the FDAs medical device review budget. They claim that increasing their financial support of the governmental agency could create a conflict-of-interest atmosphere for reviewers who are supposed to act in consumers interest.
I think the key concern was: What percentage of the (device review) funding should industry provide to the FDA, Shuren says.