(Repeats Tuesday item to additional subscribers)
* FDA to hold Thursday meeting on device approval process
* Agency device chief says no imminent changes
* Analysts see bigger impact from 2011 IOM report
By Susan Heavey
WASHINGTON, Feb 16 (Reuters) - A program that speeds U.S. approval of some medical devices will face closer scrutiny on Thursday at a Food and Drug Administration meeting expected to weigh potential changes to the controversial program.
Critics say the accelerated process for reviewing medical devices similar to other products already on the U.S. market has been expanded beyond the original goal, leading to problems with devices after they are sold.
The meeting on the process known as 510(k) is the latest in a series of changes for the FDA’s device unit, which has seen a dramatic shift under the Obama administration and created uncertainty for makers of medical devices.
Under FDA Commissioner Margaret Hamburg, the FDA has vowed to streamline the division, called for an outside review by the independent Institute of Medicine (IOM) and replaced the device unit’s chief.
Jeffrey Shuren, the new head of FDA’s Center for Devices and Radiological Health, said the division wanted input on the accelerated approval process from a broad range of people but that “at the moment, nothing is imminent.”
Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said standards for deciding if a new device is equivalent to one already-approved are “too loose to assure safety or effectiveness.”
“Our center regularly hears from patients and consumers who were harmed by LASIK, surgical mesh, bladder slings and other products that were not adequately tested prior to being sold,” added Zuckerman, who plans to speak on Thursday.
The device industry, which is expected to comment at Thursday’s meeting through its industry group, the Advanced Medical Technology Association, has said it backs the current expedited approval process.
“Some changes to the 510(k) program are likely in 2010 and 2011,” Wells Fargo Securities analysts said in a research note last week, adding that experts expect the changes to increase the evidence companies need to win approval and to increase associated costs.
At Thursday’s meeting, FDA officials will present information on issues such as new technologies and scientific evidence, as well as how information is gathered on devices once they are approved. It will also discuss how the agency has coped with a high number of device approval applications.
The discussions will be used by an internal FDA task force charged with evaluating the approval process that Shuren said is focused on recommendations “more along the lines of changes that can be made in the short term” with existing FDA powers.
However, analysts see potentially bigger changes looming for device makers when the IOM lands its report in March 2011, a review Shuren said is expected to look “far more broadly” at actions the FDA could take.
“We continue to believe that more impactful changes will result from recommendations by the Institute of Medicine,” analysts for Concept Capital’s Washington Research Group wrote in a research note.
The Institute of Medicine will hold its first public meeting on the issue March 1. Panelists at that hearing will weigh if the FDA’s current 510(k)process protects the public and, if not, what changes U.S. lawmakers or the FDA should make.
Shuren said the FDA would accept public comment on the 510(k) process for the next month before the internal task force report is made public sometime in June. (Reporting by Susan Heavey; Editing by Tim Dobbyn)