Senate Overwhelmingly Passes Unprecedented Medical Device User Fee Act

Posted in Regulatory and Compliance by Brian Buntz on June 26, 2012

The Senate passed legislation today to reauthorize the latest version of the user fee bill, which introduces performance goals for FDA. The FDA Safety and Innovation Act (S. 3187; PDF) nearly doubles the user fees paid by medical device manufacturers from a total of $295 million in the last five years to $595 million over the next five years. In all, the bill is expected to yield $6 billion in user fees from pharma and device companies from 2013 to 2017, paying for an estimated 35% of FDA's review costs for medical devices. The legislation awaits President Barack Obama's final signature before it becomes law.

 Image from Wikipedia. 

The legislation, which was supported by a vote of 92–4 in the Senate, has achieved mostly broad support among the industry and other parties.

One outlier was the Consumer Union, a division of Consumer Reports, which stated that the legislation makes some safety improvements to FDA’s review process but ultimately “falls short of what is needed to protect patients.” The group had previously stressed the need for stricter safety standards for products such as implantable devices.

Rochelle Rottenstein, principal of the Rottenstein Law Group, a New York City-based law firm found that the legislation "shortchanges consumer," in that it fails to make make the 510(k) approval process substantially safer. In addition, the legislation failrs to require the use of unique device identifiers (UDIs) that would enable FDA to better track medical device malfunctions.

Boston Scientific's CEO, Hank Kucheman holds the bill in high regard, explaining in a statement that he is optimistic that it will "have a strong and lasting impact on the FDA's ability to address lengthening review times, spur innovation and promote faster patient access to new therapies."

AdvaMed also praised the legislation, explaining that it could potentially go far in addressing concerns about the efficiency and predictability of the agency’s review process—especially for products requiring the Premarket Approval (PMA) process. In a press conference held on June 26, Stephen J. Ubl, CEO of AdvaMed explained that the legislation will “ensure that patients have more timely access to safe and effective products,” and that it would help medical technology innovators develop products that address unmet public health needs. Furthermore, It will strengthen the medical device industry, thus creating jobs that help spur the nation’s economic recovery.

The legislation is “not your father’s user fee agreement.”

—Stephen Ubl, AdvaMed CEO 

Ubl also added that the bill is “not your father’s user fee agreement.” “There are a number of firsts included in [it],” he said. “For example, it is the first agreement to include goals that are focused on total review times—measured for the first time on the time of submission to the agency to the time that the agency makes its final decision on a PMA or a 510(k),” he added. “The agreement, for the first time, includes a provision we refer to lovingly as ‘no submission left behind,’ which requires the agency to meet with companies if the agency misses a performance goal where, in the past, those submissions tended to languish.” In addition, the legislation guarantees that sponsors of a medical device have “a substantive interaction with the agency halfway through the targeted time for completion of the review.” Ubl also pointed out the novelty of the legislation’s specification of an outside management review of the agency, which includes “a corrective action plan for areas where there can be improvements.”

Ubl also explained that AdvaMed plans on working closely with FDA and other stakeholders “to ensure that the agreement is implemented effectively.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

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