The Medical Device User Fee and Modernization Act (MDUFMA) is a go. Three weeks after the Senate and House produced a reconciled version of the bill, President Barack Obama signed it into law July 9 as part of the Food and Drug Safety and Innovation Act.
The law now calls for industry to double the user fees it pays to the FDA, to nearly $600 million, primarily in exchange for faster and more consistent reviews. The FDA and industry representatives agreed to the arrangement last winter and, as the bill wended its way within and between the two chambers of Congress, it enjoyed broad support bordering on bipartisan unanimity.
Good for five years, the new fee structure will go into effect Oct. 1.
According to Advamed, one of the industry groups that negotiated with FDA to hammer out the user-fee agreement, the performance goals in the new legislation call for the agency to:
- Reduce total review times, measured for the first time from the time of submission to the time FDA makes a final decision on a premarket approval (PMA) or a 510(k), and significantly improve review performance relative to current performance;
- Leave “no submission behind” by requiring FDA to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing the review;
- Provide a substantive interaction with applicants halfway through the targeted time for completion of a review; and
- Implement an analysis of FDA’s management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.
While Advamed CEO Stephen J. Ubl surprised no one when he issued a quick commendation of legislators and cheers for the new law, the group’s chairman, David C. Dvorak, president and CEO of orthopedics manufacturer Zimmer, served notice that the FDA will be closely monitored going forward. The legislation, he said in a statement, “is only the beginning. It will require consistent and effective implementation by FDA, which will be held accountable to meeting all of its commitments. It is in the interests of patients, the industry and FDA that this legislation achieves its promise, and industry is committed to working with FDA to make that happen.”
The agency also will likely be hearing from those who opposed the government working closely with industry to set the conditions of the user-fee agreement. In a workshop and public meeting on MDUFMA in March, Kate Ryan of the National Women’s Health Network said the agreement reflects none of the concerns her group had raised about protecting the health of patients throughout the life cycle of medical devices.
The agreement, she said, “focuses primarily on proposals to streamline and speed up premarket reviews. While we understand that can have benefit to patients as well, it’s also clearly a priority of the device industry, which is currently the only non-Agency stakeholder at the negotiating table. We’re not therefore surprised at this outcome, but we are disappointed to see the opportunity to improve the FDA’s ability to meet the needs of patients and consumers go by.”
Other groups have voiced similar objections, most notably Consumers Union, publisher of Consumer Reports .
Ryan, whose remarks are posted in an online transcript, said her group will continue to advocate for patient safety in future reauthorizations of the user-fee act.