20-May-2011

Ralph Hall of B&D; Consulting believes that the Food and Drug Administration might not be legally allowed to use the Institute of Medicine's forthcoming report on the 510(k) device clearance process because representatives of several key stakeholders were not included on the panel drafting the recommendation, HealthPolicyNewsStand.com reported in its article, "Device Lawyer: Law May Preclude FDA From Using IOM 510(k) Proposals."

Hall, a device consultant who teaches at the University of Minnesota and has testified on Capitol Hill about medical device issues, said that representation for the industry, venture capitalists and patient advocates was not included on the panel. This oversight might violate the Federal Advisory Committee Act (FACA), which establishes rules on the FDA's use of Institute of Medicine (IOM) studies, the story reported.

"We question the omissions from the committee of essential expertise and stakeholders," Hall and a co-author wrote in an online article for the Minnesota Journal of Law, Science and Technology on May 11. "These issues are so serious that (FDA) may be legally prohibited from using any of the 510(k) committee's recommendations."

The FDA has countered criticisms of the IOM panel composition, contending that venture capitalist and patient representation would result in conflicted individuals sitting on the committee. However, Hall claimed that FACA allows some conflicts of interest to be present on committees when they are unavoidable and that many previous committees have documented such conflicts. Therefore, he said he doesn't accept the FDA's explanation for why industry representation was not allowed on the committee, according to HealthPolicyNewsStand.com.

Hall then described FACA language stating that a failure to follow the law's rules would result in an inability to use the advice or recommendations provided by the committee. The lack of representation on the IOM committee could lead to legal challenges for the FDA in the future, Hall said. "If the agency is prohibited from using the report, but then incorporates it as part of its process of arriving at recommendations, you could see some disgruntled stakeholder … objecting on the grounds that they failed to satisfy the statutory requirements in using this report," Hall said in the story.

The best option is for the FDA to forgo the report and move forward on its own to reform the 501(k) process, according to Hall. Other options include adding the missing stakeholders to the IOM committee or restarting the IOM process with a new panel. Most importantly, he recommended that the committee not release its report until the lack of balance is resolved."(W)e can't unring a bell — once the committee issues its report, we will never know whether FDA saw it, read it or used it," his article states. "Thus, we should address this situation immediately."

Hall expects to send a copy of his report to FDA and plans to further explore the issue in the future, HealthPolicyNewsStand.com reported.