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Congress Passes FDA Medical Device User Fee Bill

NEW YORK (GenomeWeb News) – The US Senate yesterday passed a bill that will reauthorize the Food and Drug Administration's medical device user fee program, enabling the agency to collect an additional $308 million over five years to fund its regulatory activities and to take steps to modernize its review and approval processes.

This passage marks the final vote on the FDA Safety and Innovation Act (S. 3178), as members of the Senate and House of Representatives worked out a final version of the bill over the past few days.

The bi-partisan act sailed through its last passage on a vote of 92 to 4, with 4 abstentions, and will now head to the White House.

In the Senate Chamber yesterday, Sen. Richard Burr (R - NC) said that the bill was hurried through final negotiations because Congress wanted to get it to President Obama before the Supreme Court issues a ruling on the Patient Protection and Affordable Care Act.

The bill reauthorizes the Medical Device User Fee Act (MDUFA), the program FDA uses to bring in fees from industry to support its operations and which is scheduled to expire at the end of September, through 2017. It also extends the Prescription Drug User Fee Act and adds user fee programs for generic and biosimilar drugs. All told, the bill is expected to provide FDA with $6 billion in fees over a five-year period.

The bill also requires FDA to implement new performance goals in its review processes.

Under the MDUFA, FDA will collect $595 million over the next five years in user fees paid by industry, compared with $287 million over the past five years, and the agency will be required to take a number of steps to streamline its regulatory processes and enhance transparency, efficiency, and consistency.

The extra funds will enable FDA to hire more than 200 full-time employees to support the medical devices review programs, on top of another 32 it already plans to have hired before the end of 2012, and would provide for enhanced training programs for staff.

"The FDA bill will help bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs," Senators Mike Enzi (R - Wyo.) and Tom Harkin (D - Iowa) said in a joint statement yesterday. "This bill will help the FDA do its job more effectively, increasing accountability and transparency, so US companies can innovate and compete in the global marketplace."

The new user fees legislation is the product of agreements that were hammered out between FDA, industry, and members of Congress over nearly two years of negotiations, and reflects concerns about the agency's performance in handling its review duties.

Attesting to those concerns, Director of the FDA's Center for Devices and Radiological Health Jeffrey Shuren told a Senate committee in March that "industry felt that inadequate predictability, consistency, and transparency were stifling innovation and driving jobs overseas."

The MDUFA program was launched in 2002 as a response to similar worries at that time about FDA's capabilities. It authorized the use of user fees to pay for review of pre-market applications, reports, supplements, and pre-market notification submissions, and it was renewed in 2007.

"This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency," Stephen Ubl, president and CEO of the Advanced Medical Technology Association, or AdvaMed, said in a statement yesterday. "That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry."

AdvaMed said that the new plan "includes a series of strong, measurable performance goals and additional funding that should help reverse the decline in performance FDA has experienced in recent years."

The MDUFA section of the act includes several new performance goals aimed at making FDA's review process more efficient. According to AdvaMed's analysis, the bill will reduce total review times, measured from when FDA receives a submission to when it makes a final decision for 510(k) status or pre-market approval.

It also will require FDA to meet with companies if a review goal for a 510(k) or PMA is missed to work out a plan for completing the review, and it will provide substantive interaction with applicants halfway through the review process.

AdvaMed also pointed out that the act will implement an analysis of FDA's review process by an independent consulting organization, and it will require the agency to take corrective measures based on that assessment.

Taken together, these measures and the expanded resources and staff at FDA will improve the "timeliness and predictability" of the review process, AdvaMed said, adding that the passage of this bill, however, 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," AdvaMed Chairman David Dvorak, who also is president and CEO of medical device firm Zimmer, said.

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