Cracks in FDA’s Medical Device Approval Process Allow Unproven Devices to Slip Through

July 13, 2010  

Cracks in FDA’s Medical Device Approval Process Allow Unproven Devices to Slip Through

Journal Article by Public Citizen Researchers Highlights How Questionable Devices Get Approved, Recommends Significant Changes

WASHINGTON, D.C. – The government’s system of approving medical devices is broken, allowing potentially ineffective devices on the market largely because approval rules are too lax, contain loopholes and are inadequately enforced, according to research by Public Citizen published in PLoS Medicine today.

The authors outline eight weaknesses in the device approval process and recommend significant changes that both the Food and Drug Administration (FDA) and Congress should make. They illustrate each of these weaknesses with examples of devices that were approved despite questions about their safety or effectiveness. The article is available at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000280.

“The FDA’s mission is to protect public health, but allowing questionably effective products onto the market is inconsistent with that mission,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group and one of the authors.

Added the lead author, Dr. Jonas Hines, a former Public Citizen health researcher who is doing a medical residency at University of California, San Francisco, “Medical devices are becoming increasingly important in health care. It is vital that devices are shown to be safe and effective before they are used in patients.”

There are two general approval procedures for devices. One, the “premarket approval” (PMA) pathway, is analogous to the drug approval process. In the other, termed “premarket notification” submission and often referred to as “510(k),” a manufacturer need only demonstrate that the new device is “substantially equivalent” to a marketed device. While PMA applications are reserved for high-risk and novel devices, the vast majority of devices proceed down the 510(k) route.

The weaknesses identified by the authors include:
• A lower approval standard for devices than for drugs;
• Lax interpretation of the requirements for the 510(k) pathway;
• A loophole that allows manufacturers of novel devices to circumvent the PMA pathway;
• Failure of the FDA to appropriately regulate many types of devices that were first marketed prior to the 1976 enactment of the current regulatory scheme; and
• A superfluous appeal mechanism that gives manufacturers a second go for approval after FDA has rejected a device.

To make matters worse, the law directs the FDA to consider the “least burdensome” means of showing effectiveness for devices, giving manufacturers recourse to challenge many FDA requests it considers onerous. And fees paid by the medical device industry for FDA reviews make the agency beholden to the industry it is supposed to regulate.

As a consequence of these weaknesses, devices can reach the market when in fact they should not, the authors wrote.

For example, the vagus nerve stimulator is a surgically implanted device approved to treat severe depression. The trial submitted to the FDA for approval showed no statistically significant benefit for patients in the primary outcome. And even though FDA reviewers initially said it shouldn’t be put on the market, the then-director of the FDA device center reversed direction and approved the device. The Centers for Medicare and Medicaid Services has since said the device is of such questionable value that it refuses to reimburse for it. Still, it remains on the market.

 Also cited is ReGen’s collagen scaffold, a device implanted to replace a damaged meniscus in the knee. The trial conducted for approval showed no benefit for the scaffold over traditional surgery. However, this crucial fact was obscured when the agency allowed the company to use the less-stringent 510(k) process comparing it to multiple approved devices of questionable similarity. The FDA eventually approved the device; a subsequent FDA report documented a flawed review process, influenced by pressure from the company and Congress. The prestigious Institute of Medicine is now conducting a review of the 510(k) process following the highly publicized ReGen controversy. The FDA is reconsidering its approval of the device; the Centers for Medicare and Medicaid Services  determined in May that “the collagen meniscus implant does not improve health outcomes” and will not reimburse for it.

 The paper’s authors – Hines, Wolfe, Dr. Peter Lurie (former deputy director of Public Citizen’s Health Research Group, now senior advisor in the Office of the FDA Commissioner) and Eunice Yu (former Public Citizen health researcher and current medical student at the University of Michigan) – recommend that these weaknesses be addressed through a combination of legislation, regulation and changes in agency practice.

“The American public is best served when the FDA rigorously reviews devices, particularly those used to treat diseases or that are permanently implanted. Only through a multi-tiered approach to tighten the device approval process can we adequately protect the public’s health,” Hines said.

Note: Author Lurie testified in front of the Subcommittee on Health of the Committee on Energy and Commerce of the U.S. House of Representatives about some of these problems in June 2009. His testimony is available at https://www.citizen.org/our-work/health-and-safety/articles/testimony-encouraging-more-rigorous-approval-process-medical.

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