FDA Denies Legal Group Seeking to Ban IOM Recommendations

March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administration February 21 after the industry-tied group tried to have the recommendation of an expert scientific panel barred from FDA consideration and implementation.

The WLF is made up of corporate inside-the-beltway attorneys whose mission is "defending free enterprise" and championing "free market principles, limited an accountable government, individual rights, business civil liberties, and legal ethics.”

In other words, a Chamber of Commerce working to promote business and industry in the legal arena with a well-heeled legal advisory board here. The Honorable Dick Thornburgh is chairman of the WLF Legal Policy Advisory Board.

The group took issue with the Institute of Medicine (IOM) report issued last July that said the 510(k) approval process for medical devices should be abolished, calling it "fatally flawed."

Industry stakeholders have criticized the IOM panel saying it was not balanced. Last June, the WLF petition argued that any advice the FDA took from the IOM report would be a violation of the Federal Advisory Committee Act (FACA) because the IOM panel didn't contain anyone from industry, entrepreneurs, venture capitalists, inventors or anyone familiar with the 510(k) process of bringing medical devices to market through the fast-tracked procedure.

In response, the agency said it is not required to determine whether the membership of a panel satisfies the FACA fair and balanced standard.

The IOM panel was composed of 12 members, including five doctors, three lawyers, and several academics with a variety of technical backgrounds.

Conclusion by the IOM

“The IOM finds the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness through the device life cycle. The IOM outlines its criteria for this framework in this report.”

The FDA did not have a favorable review of the IOM report at the time saying the agency did not believe the 510(k) process should be eliminated, but that it was open to additional proposals.

A spokesman for the industry group, Advamed (Advanced Medical Technology Association), told Bloomberg BNA that he "does not expect FDA to do much of anything with the IOM recommendations."#

Learn More:

A copy of WLF's June 28, 2011 citizen petition is at http://op.bna.com/hl.nsf/r?Open=deln-8rysyn.

A copy of FDA's Feb. 21 denial of the citizen petition is at http://op.bna.com/hl.nsf/r?Open=deln-8rwlss.

The IOM panel report here. (PDF)