Debate in Congress over a bill that would nearly double the user fees medical device manufacturers and pharmaceutical companies pay the U.S. Food and Drug Administration (FDA) is over. The U.S. House of Representatives passed the bill, as did the Senate 92-4. The FDA Safety and Innovations Act will increase the total user fee revenue from $295 million over the previous five years to a projected $595 million over the next five years. As the large majority of Senate votes for the law indicates, the medical industry strongly supports the bill.
On the other hand, Rochelle Rottenstein, principal attorney and founder of the Rottenstein Law Group, voiced her criticisms of the law when interviewed for a blog post on DeviceTalk, which belongs to the medical device magazine Medical Device + Diagnostic Industry.
Legislation Doesn’t Improve Broken Device Approvals Process
When asked about the law, Ms. Rottenstein opined that it “shortchanges consumers” because it does nothing to improve the 510(k) premarket approval process that allows companies to sell their products without subjecting them to clinical trials. A prominent example of how this process failed is DePuy Orthopaedics’ ASR hip replacement systems, which are metal-on-metal devices that their manufacturer recalled due to their high failure rates. The recall has spawned numerous hip replacement lawsuits, some of which the Rottenstein Law Group is representing.
Ms. Rottenstein elaborated:
“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 … 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.”
In the ASR’s case, the predicate was another device approved through the same process in a chain of approvals going back to the 1970s before the law was adopted and long before all-metal hip implant technology had been developed.
“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 … 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.”
FDA Regulations Still Need Reform
When asked how she would change how the FDA works if she were appointed its commissioner, Ms. Rottenstein said:
“[I would] 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. … 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.”
RLG Represents People Injured by Defective Medical Devices
These are good ideas and it’s too bad Rochelle Rottenstein will probably not be heading the FDA anytime soon. Nor will the law prevent future catastrophes as the DePuy hip replacement recall. Even if the 510(k) premarket approval process is reformed, it won’t do anything for people who’ve received defective medical devices. If you were implanted with a recalled ASR device, hiring experienced legal counsel such as the Rottenstein Law Group is safer than trying to take on DePuy alone because the amount of compensation from a hip replacement lawsuit might be greater than what DePuy is willing to offer via its recall reimbursement program. For a free consultation, click on this link or call 1-877-312-3274.
For more information download this free DePuy ASR brochure.