When the Senate passed the resolution reauthorizing the latest version of the user fee bill (which will present the performance targets for the United States Food and Drug Administration), Rottenstein Law Group (RLG) founder Rochelle Rottenstein aired her view about the medical device bill, on mddionline.com
RLG is a New York City-based law firm specializing in consumer product injury cases, including suits against the makers of vaginal mesh and hip implant products, which have been reported as defective.
Rottenstein believes that the medical device user fee legislation, which has been sanctioned by the Congress “Shortchanges the consumers,” benefits and protects hip implant recipients.
“Perhaps the most significant way it does that is by failing to include provisions that would have made it more difficult for medical device manufacturers to obtain FDA approval for devices that are ‘substantially equivalent’ to devices the FDA has already approved,” she says.
The FDA Safety and Innovation Act (S. 3187; PDF) nearly doubles the user fees paid by medical device manufacturers from a total of $295 million in the last five years to $595 million over the next five years. In all, the bill is expected to yield $6 billion in user fees from pharma and device companies from 2013 to 2017, paying for an estimated 35% of FDA’s review costs for medical devices. The legislation awaits President Barack Obama’s final signature before it becomes law.
Rottenstein expounded on the issue that earlier repetitions of the Medical Device User Fee Act closed a loophole in the 510(k) approval procedure that permits risky medical devices to enter the market.
The loophole, which she explains, still exists in the most recent bill, and is based on the 510(k)’s emphasis on substantial equivalence rather than clinical testing on humans. “When a device maker applies for FDA approval pursuant to the 510(k) approval process, the already-approved device the manufacturer cites is known as a predicate.”
“Current law requires the FDA to approve devices that cite an eligible predicate unless the older device has been ordered off the market by the FDA or a court order,” she says. “Since, oftentimes, FDA-approved devices that prove dangerous are voluntarily taken off the market by their manufacturers before the FDA or the courts have a chance to act, dangerous devices can serve as the basis for new-product applications that the FDA is obligated to approve.”
The FDA clears 28 devices annually, citing a predicate that has been recalled by its manufacturer, according to Jeffrey Shuren, director of FDA’s CDRH division. “Among [those products] were vaginal mesh implants that traced their designs to a product recalled by Boston Scientific,” she said. “Those devices have sparked hundreds of lawsuits from patients who say vaginal mesh implants left them seriously injured.”
When asked what she would change at FDA if she were its commissioner, Rottenstein says her first order of business would be to “close the 510(k) approval process loophole as well as require the use of unique device identifiers (UDIs) that would enable the FDA to better track medical device malfunctions.” She continues: “UDIs are bar-code-like identification numbers that the FDA plans to assign to medical devices. Earlier versions of the MDUFA included provisions to speed up the FDA’s implementation of a system like that.”
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