Consumer advocates turned up the volume on efforts to influence the upcoming vote on the FDA’s medical device user fees, issuing a new campaign targeting the "loopholes" in FDA review.
"Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?" reads the ad, which began running in Politico today. "The answer is obvious. But for months, their lobbyists have been working to block Congress from giving the FDA the power to require this proof."
Watchdog groups, and Consumers Union in particular, have been active in lobbying efforts targeting the re-authorization of the medical device user fee act, which doubles the amount industry will pay for FDA review over the next 5 years in exchange for certain performance goals.
The U.S. Senate late last month sped the bill along with near-unanimous support and the measure may hit the floor as soon as next week. A House version of the bill flew through a subcommittee earlier this month. The White House in February put its stamp of approval on the bill, which won FDA and industry support in negotiations.
Consumers Union wants the FDA to have broader authority to require medical device makers seeking clearance to speak for failures in predicate devices. Under current law, the FDA has no power to force companies to prove that new devices are free from flaws that led to recalls or safety issues in prior products that are serving as a foundation for review.
"It’s time to close this absurd loophole and give the FDA the power it needs to protect patients," Consumers Union’s Safe Patient Project director Lisa McGiffert said in prepared remarks. "But so far, the politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients."
The group held up recent controversies over transvaginal mesh implants, metal-on-metal hip replacements and recalled heart devices as example of the failure of the FDA’s 510(k) process, which allows device makers to bypass federally mandated clinical trials for new devices if they are found "substantially equivalent" to products already on the market. More than 90% of medical devices are cleared though the 510(k) "fast track," rather than the more stringent pre-market approval process, according to the group.
"Medical device makers have misled Congress that this reform isn’t necessary, but the evidence is clear that the FDA doesn’t have the power it needs to protect patients," McGiffert added. "It’s time to use some common sense and close this indefensible loophole in the law."
Consumers Union, the policy advocacy arm of Consumer Reports, has been a loud voice in the debate over medical device regulation. The group in March released poll results showing “overwhelming” support for more oversight of medical devices.
The group itself got a harsh review for over-simplifying the medical device review environment and disregarding studies that weren’t conducted in humans.
"The Consumers Union is not correct in its representation of the industry, claiming, ‘most medical implants have never been tested for safety,’" MDDI Online reported in April. "This is blatantly untrue."
