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Senate passes FDA user fee renewal bill

by Brendon Nafziger , DOTmed News Associate Editor
The U.S. Senate passed the Food and Drug Administration user fee reauthorization bill in an easy 92-4 vote Tuesday. The legislation now heads to the president to be signed.

The FDA Safety and Innovation Act, or S. 3187, which sailed through the House of Representatives last week, renews the FDA's user fee program for another five year chunk, starting in 2013. In the program, the FDA collects fees from drug and device makers to help pay for speedier review times.

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"We have taken an important step to improving families' access to lifesaving drugs and medical devices," Tom Harkin, an Iowa Democrat, said on the Senate floor.

The renewal, which authorizes the FDA to collect some $6.4 billion from the industry, comes with a number changes from earlier user fee programs. It now includes generic drugs and biologics, for instance. It also features tweaks that have been championed by medical device manufacturers. Under the new law, for example, the FDA must measure the time it spends reaching a decision on a device submission by the total time used, rather than in "FDA days."

"This user fee agreement really isn't your father's user fee agreement," Stephen Ubl, president and CEO of AdvaMed, a device makers lobby, told reporters on a conference call Tuesday.

Ubl said the agreement also includes, for the first time, what the industry calls "no submission left behind," which requires the agency to meet with companies if they miss a performance goal in the submission process. The new agreement also guarantees a meeting with the agency midway through the review process and requires outside management review of the FDA's processes, and following that, a corrective action plan.

Review times are also sped-up. For instance, for 510(k) clearances, which cover much imaging equipment and other moderate-risk devices, the goal will move from 90 percent of products receiving a decision in 90 days, to 95 percent by 2017. For pre-market approvals that require a panel review, a more rigorous process, the improvement is meant to be more dramatic: going from 38 percent receiving a decision in 320 days, to 90 percent by 2017, according to an AdvaMed fact sheet.

In return for more transparency and speedier reviews, the amount shelled out by device companies in fees will nearly double, reaching $595 million. But with a bigger budget, the FDA will also be able to hire 208 new reviewers, including 32 full-time employees by the end of the fiscal year, AdvaMed said.

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