Senate panel adds safety measures to FDA user fee act

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A key U.S. Senate panel today approved a bill designed to tighten safety standards at the FDA’s medical device arm, but the committee’s markups to the measure failed to win support from consumer advocates.

The Senate’s Health, Education, Labor and Pensions Committee voted to approve the "Food & Drug Administration Safety and Innovation Act," which would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials. The only "nay" in the voice vote was Sen. Bernie Sanders (I-Vt.).

The bill, known as the "Medical Device Safety Act" when it was introduced late last year by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would also strengthen the FDA’s 510(k) protocol, which allows device makers to show that their products are similar to already-cleared devices without requiring extensive clinical trials.

Hard on the heels of the panel’s vote today, the advocacy arm of Consumer Reports, Consumers Union, issued a statement saying the bill still does not go far enough to keep patients safe from the flaws in the 510(k) system.

"The FDA’s current fast track review process has allowed too many dangerous and defective devices onto the market," Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in prepared remarks. "To make matters worse, the FDA doesn’t have the tools it needs to react quickly when safety problems with medical devices arise. Unfortunately, this bill doesn’t fix some of the most serious flaws in our current system and leaves patients at risk."

The panel vetoed an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would have given the FDA’s Center for Devices & Radiological Health "predicate nullification" authority – the ability to reject 510(k) applications based on recalled devices. Merkley formally withdrew the amendment ahead of the panel’s vote today, saying he hopes to negotiate it into the bill before it hits the full Senate floor for a vote.

"This seems like basic common sense," Merkley told colleagues today. "This is not a drastic revision. It says, ‘Look, you can still use a device as a predicate if you can show that that safety issue has been addressed.’"

Merkley’s amendment also would have beefed up the CDRH’s power to mandate post-market surveillance and set a deadline for implementing a universal identification program. The advocacy group said it backs Merkley’s proposals.

"Consumers Union has urged the committee to strengthen the bill by prohibiting the clearance of new medical devices based on recalled ones; improving the system for monitoring devices once they are cleared for sale; providing the FDA with greater authority to require post-market safety studies; and retaining current strong conflict of interest standards," according to the release.

The group said it opposes measures put forward by Sens. Rand Paul and Orrin Hatch that would "undermine current FDA standards on prescription drug and medical device recalls" and "prevent the FDA from up-classifying medical devices to require stricter safety testing."

Rand and Hatch also withdrew their amendments ahead of today’s vote. Like Merkley, they said they didn’t want to stand in the way of so-called "must-pass" legislation, which also contains the FDA’s budget and would double the user fees paid by medical device manufacturers. Congress has to get a bill to President Barack Obama by Oct. 1; the House Energy & Commerce Committee is slated to consider a companion bill tomorrow.

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