27-July-2011

Ralph Hall, a device industry advisor with B&D; Consulting and professor of law at the University of Minnesota, pre-emptively challenged the validity of a report by the Institute of Medicine that proposed a stricter approval process for a wide range of medical devices, The New York Times reported in its article, "Study of Medical Device Rules Is Attacked, Unseen."

Commissioned by the Food and Drug Administration, the report was released on July 29, 2011, by the Institute of Medicine, a scientific group that assembles experts to examine possible new regulations on the industry. In 2009, the FDA contracted with the group to review the adequacy of the 510K process, one of the two regulatory pathways through which it approves medical devices such as hip implants, hospital pumps and external heart defibrillators.

Hall and several other organizations and individuals, including the Washington Legal Foundation and the American Academy of Orthopaedic Surgeons, took the unusual step of questioning the report's credibility even before its release based on concerns that the panel was biased. Earlier this year, Hall wrote an article with a colleague arguing that the Institute of Medicine, in selecting its panel, had violated a little-known rule, the Federal Advisory Committee Act, which requires balance on such committees.

"I could have waited until the report came out," Hall said in an interview with The New York Times." That seems intellectually less than satisfactory to me."

The 12-member review panel issuing the report included physicians, academics, two lawyers who had worked for device makers on regulatory issues and another lawyer who had worked for Public Citizen, a consumer advocacy group. The Washington Legal Foundation argued that the Institute of Medicine had failed to balance the panel by including officials from the industry, the investment community, practicing surgeons and patients who had benefitted from devices.

The foundation filed a petition with the FDA in June 2011 arguing that the agency is statutorily barred from adopting any of the report's recommendations because of what it maintained was the panel's bias, The New York Times reported.

"We wanted to let FDA know that there are significant concerns with the composition of the committee," said Richard A. Samp, a lawyer for the legal foundation.

Over the last year, the panel charged with reviewing device approvals has held hearings to gather feedback and data from all interested parties, including device producers and investors.

Device producers have released a series of their own reports that say more regulation would slow innovation, harm patients and cost jobs, although the value of these studies was questioned by the editors of two medical journals.

Dr. William Maisel, the chief scientist of the FDA division that oversees medical devices, told The New York Times the agency was satisfied with the panel's makeup and added that the FDA was not bound to accept the report's recommendations.

Medical experts said the institute's study, regardless of how it falls, was likely to have significant impact on patient safety, device effectiveness and the speed at which new products reached the market.