U prof leads campaign against device report

by Katherine Lymn

By reporter Sally Hunter:

A University of Minnesota law professor has been leading a campaign challenging a report that could propose a harder approval process for a variety of medical devices, according to the New York Times.

Law professor and medical device lawyer Ralph Hall, along with industry allies, argues that the Institute of Medicine’s report is biased and unbalanced.

After several recalls of medical devices in recent years, the Food and Drug Administration commissioned the Institute of Medicine to conduct a report on medical devices. The report will be released Friday, making the campaign is a “pre-emptive strike,” the Times reported.

Hall and a colleague wrote an article this year arguing that the Institute of Medicine violated the “little-known” Federal Advisory Committee Act, which requires committees like that of the Institute of Medicine to be balanced.

The committee consisted of 12 members including physicians, academics and lawyers.

The Washington Legal Foundation, a pro-business group, also argued that the committee is biased because it should have included patients that benefited from devices, officials from the industry or officials from the investment community.