FDA Criticized for Unsafe Medical Device Approval Process

Cheryl Clark, July 15, 2010

Eight serious loopholes and cracks in the U.S. Food and Drug Administration's approval process allow potentially unsafe, ineffective yet high-risk machines and materials to be approved for use on patients, according to an article by the advocacy group Public Citizen.

"Discretion has been applied in an expansive manner favorable to industry," the authors wrote.

The researchers say the underlying problem is that the FDA scrutinizes medical devices by using thresholds that are far lower and more lenient than those required for pharmaceutical products, although they have just as much potential to harm. Certain drug-device combinations hospitals use, such as drug-eluting stents, are regulated as devices, as are MRI machines, heart valves and defibrillators, implantable sheaths and scaffolds, as well as grafts and intraaortic pumps.

They say that fixing the problems require actions by Congress, changes in regulation, as well as corrections in the agency's practices.

The group, whose authors include Peter Lurie MD, now a senior advisor in the FDA's Office of Commissioner, and Public Citizen director, Sidney Wolfe MD, published the article in this week's edition of the Public Library of Science Medicine.

"We want to raise awareness about structural defects in the medical device approval process that can allow devices to reach the patients despite knowing very little about their safety or effectiveness," says the report's lead author, Jonas Hines, formerly of Public Citizen now engaged in a medical residency at UCSF.

The authors point to a key failing in the FDA's 510(k) rule, which allows a manufacturer to establish that a device is safe and effective simply by demonstrating that it is substantially equivalent to an existing "predicate" device, based on the intended use, even if the device is quite different. The authors termed this approval process as "predicate creep."

"The 501(k) process allows sponsors to identify a predicate device that was itself substantially equivalent to another device that was substantially equivalent to another, and so on. This iterative process permits a scenario in which, over multiple cycles, a new device can be quite dissimilar to the original predicate device—so-called ?predicate creep,'" they wrote.

The authors used eight examples to illustrate the eight flaws failings in the FDA process. One involved ReGen's collagen scaffold, approved in 2008, which surgeons use as an implant to replace a damaged meniscus in the knee.

Though a clinical trial showed that the scaffold was no better than traditional meniscectomy without the scaffold, it was approved under the 510(k) rule because similar mesh devices had already been approved. However none of the similar meshes were intended to facilitate the regrowth of articular cartilage in a weight-bearing joint.

Looking back, an FDA report last September criticized its own review process in the ReGen scaffold, and described "a contentious review process," with the FDA ultimately acceding to intense pressure from ReGen and its Congressional advocates by altering its typical review procedures.

"Irregularities included unusual involvement of senior FDA leadership—including the then-FDA commissioner—in decisions usually made at lower levels, a shortened review time" and replacement of advisory committee members and a review team that were more likely to favor the device, the authors wrote.

The FDA is now re-evaluating its approval of the scaffold.

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