Both the Senate and the House recently approved bills aimed at boosting funding for the U.S. Food and Drug Administration's pre-market scrutiny of drugs and medical devices. The bills also contained provisions that would tighten regulations and benefit consumers. But consumer advocates say they missed the boat on a huge problem -- neither bill addressed the loophole allowing manufacturers to base new medical devices on old ones that were recalled.
A recent Register investigation, "A Dangerous Shortcut," explained how medical device manufacturers have widened a loophole so that some 90 percent of all medical devices are cleared for market through a fast-track process called 510 (k). To gain clearance, a medical device must only be "substantially equivalent" to a device already on the market, called a "predicate." The 510 (k) process requires no clinical testing to determine whether a device is safe and effective.
Under this process, a predicate can even be a device that was recalled because of defects. Rep. Edward Markey (D-Mass), who introduced a bill to close the loophole, compared the practice to modeling a new vehicle after a car known for breaking down. Markey's bill would empower the FDA to reject a new device that is based on one recalled because it was unsafe.
The law would have been useful in the problems with trans-vaginal mesh, used to treat incontinence and a condition called prolapse. In 1999, a certain type of vaginal mesh was recalled. But it was still used as the predicate for other versions of mesh that are still on the market. The mesh has resulted in nearly 4,000 adverse reports, three deaths, and hundreds of product safety lawsuits.
Despite pressure from groups such as Consumers Union, the loophole provisions were not included as amendments to the Senate and House reform bills. Both bills contain amendments that will help the FDA, such as a Senate provision to track problematic devices. Another provision requires high-risk devices that were grandfathered-in when the medical device law was passed in 1976 to undergo clinical trials.
But consumer advocates say the bills still fall far short.
"I don't think the loophole will get closed for another five years (when the funding bill comes up for renewal)," said Lisa McGiffert, head of the Safe Patient Project for the Consumers Union.
McGiffert said that the manufacturer's group, AdvaMed, lobbied hard to keep the loophole provisions out of the bills in both houses. AdvaMed distributed a document that contended the provisions were unneeded.
"Today's program successfully governs the vast majority of medical devices, offering FDA significant discretion to apply the necessary degree of regulation to ensure that new devices are safe and effective," said the AdvaMed document, obtained by the Watchdog.
AdvaMed declined to comment for this story.
McGiffert said it was unlikely that the loophole provisions would continue as standalone bills.
According to a statement from Consumer's Union, the consequences could be "disastrous for patients who naturally assume the FDA has the ability to assure new devices don't repeat design flaws."