Food and Drug Administration, Institute of Medicine, Medical Devices, Ralph Hall, Regulations, FDA, Medical, IoM Report on FDA draws fire before release

SAN JOSE, Calif. – A major report on the future of medical device regulations to be released tomorrow is already drawing criticism.

The Institute of Medicine will release tomorrow a report commissioned last year by the U.S. Food and Drug Administration. The report is expected to provide recommendations about several of the most controversial issues around regulating medical devices.

In January, the FDA released plans for as many as 25 changes it will make starting this year to its so-called 510(k) process, the primary regulatory pathway for medical devices. The agency deferred to the IoM report on about seven contentious questions. They include:

• Should the FDA have power to revoke a 510(k)?
• Should the FDA create a new Class IIb category for devices?
• Should the FDA consider "off-label" uses of a device when reviewing it?
• Should the FDA continue reviewing products even after they have been approved for use?
• Should companies be required to keep on hand examples of all their products in case the FDA needs a review model?

In May, a University of Minnesota law professor and medical device expert co-authored a paper criticizing the makeup of the IoM committee and its process for creating the report.

"I have absolutely no idea of the substance of the report, it's the IoM process I have concerns about," said Ralph Hall who also acts as a legal adviser to medical device companies on a part time basis and has founded his own cardiac implant startup.

The IoM committee consists of physicians, academics and lawyers who have worked with medical device clients. Hall said he had no issues with the existing members of the IoM panel, only those left out.

"There are no patient representatives, no one from industry, no entrepreneurs or innovators--those are all critical stakeholders," Hall said. "Other IoM committees usually have these sorts of people," he said.

The group has not held a public meeting for a year, and it was relatively opaque at that July 2010 meeting, Hall added. The group has held no meetings since January when the FDA specifically added the contentious questions to its charter, he said.

At the July 2010 meeting, "they said almost nothing, it was unidirectional--you might get a question or two, but there wasn't a give-and-take exchange," said Hall who addressed the group at the meeting.

"Most government reports are released in a draft form for public comment before they are made final," said Hall. "I have absolutely no idea of the substance of the report, but I wish I had some insight," he said.

The FDA will likely provide time for public comment before it decides what actions it will take based on the report.

A representative of the IoM said the committee has followed the processes outlined by its parent group, the National Academies.

"The IoM assembled a committee of experts who have the necessary backgrounds and expertise to respond to the task and who do not have financial conflicts of interest," an IoM spokeswoman said.

"The IoM followed the same study process that it has used to issue hundreds of reports," she said. "We believe that upon reading the report, people will be able to make up their own minds about the committee and its recommendations for improving the Class II device clearance process," she added.

The medical device industry has lobbied for some time in an effort to relax FDA regulations. A PriceWaterhouseCoopers report earlier this year ranked the FDA as the seventh of nine global agencies in the speed of its approvals.

Food and Drug Administration, Institute of Medicine, Medical Devices, Ralph Hall, Regulations, FDA, Medical, IoM Report on FDA draws fire before release