March 7, 2012 ~ Bloomberg BNA

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)

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This is sparked by the July release of the Institute of Medicine report (here) that has the medical device industry up in arms. It calls for scrapping the 510(k) clearance process and starting over. While some medical devices such as Class III (high risk) must provide scientific evidence through clinical trials of safety and effectiveness, other manufacturers merely exchange paperwork and claim their device is substantially equivalent to another device, a predicate, already cleared by the FDA.

If the FDA decides as a compromise position to create a moderate risk category with different qualifications for approval it no doubt would slow the entry of new medical devices into the marketplace and increase investment dollars.

Morningstar recently cut the fair value estimates of Stryker and Zimmer by about 5% each due to the increased scrutiny expected from regulators following the IOM recommendations.

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An industry group took a pre-emptive strike even before the IOM release calling the report biased and saying it would slow innovation.

“Christine Stencel, a spokeswoman for the Institute of Medicine, which is part of the National Academy of Sciences, said the group was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it.

“Dr. Sheldon Greenfield of the University of California, Irvine, who has served on several Institute of Medicine panels, said he was surprised by the campaign’s intensity. “It is pretty audacious,” he said.”

A University of Minnesota professor of law, Ralph F. Hall, who also is a medical device industry lawyer, said the criticism is aimed at how the review has been conducted and not a way to front-run the report.  Minnesota has been a hub of much of the criticism about tightening medical device approval of late.

See the rest of the story here.

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Dr. Jeffrey Shuren, who heads the FDA’s device division flew to attend a town hall meeting  with executives to assure them it might not be necessary to start all over with 510 (k).

The Food and Drug Administration is looking for more input after receiving a recommendation last week that it scrap the controversial pathway for medical device approvals (510(k)) and design a new process.

FDA officials told device industry executives at a town hall meeting in St. Paul on Tuesday that they remain open to ideas to improve the 510(k) method of device reviews, which generally doesn’t require clinical trials. The agency is gathering public comment, a process that should be complete by October.

“Let’s have that discussion,” said Dr. Jeffrey Shuren, head of the FDA’s device division. “If there are any recommendations that make sense, we’ll consider them.”

Read the rest of the story here. 

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