Lurie Joins FDA: Critic Of Agency, Industry Will Help Make Regulatory Policy

Full article reprinted from "The Gray Sheet" - October 26, 2009

One of the most outspoken critics of the device industry and FDA's device center has been named to a top-level position within the agency. Read more...

Lurie Joins FDA: Critic Of Agency, Industry Will Help Make Regulatory Policy

Full article reprinted from "The Gray Sheet" - October 26, 2009

One of the most outspoken critics of the device industry and FDA's device center has been named to a top-level position within the agency.

Peter Lurie, M.D., has been appointed as an advisor to FDA's Assistant Commissioner for Policy David Horowitz, according to an internal memorandum sent to agency employees Oct. 16.

Lurie moves to the agency from the consumer advocacy organization Public Citizen, where he spent 11 years as deputy direct of the Health Research Group.

He often used that post to publicly pressure FDA to take a more conservative approach to product approvals. Lurie also has been sharply critical of alleged conflicts of interest among agency staffers and advisory panel members, as well as of drug and device direct-to-consumer marketing efforts.

The internal FDA memo's description of Lurie's new position appears to allow him a broad sphere of influence at the agency. "He will help develop strategies to facilitate medical product availability to meet critical public health needs," the memo says.

Lurie's appointment may accomplish dual goals for the Obama administration: addressing head on criticism that FDA is too close to the industries it regulates, and giving the agency a degree of control over one of its most outspoken critics.

A Strong Voice For Device Review Reform

The appointment also presents more evidence that the agency is preparing to tighten up its pre-market review criteria for devices.

Lurie joins the agency less than a month after FDA released preliminary findings from an unprecedented internal evaluation of a prior device clearance - for ReGen Biologics' Menaflex knee meniscus collagen scaffold - which identified serious flaws with the 510(k) assessment and with the 510(k) process in general (The Gray Sheet' Sept. 28, 2009).

In parallel with the Menaflex report, FDA formed an internal task force to assess the 510(k) program and contracted with the Institute of Medicine to do the same.

Lurie and his colleagues at Public Citizen have been critical of the Menaflex review process at least since the controversial November 2008 FDA advisory panel review of the product. His push for changes to the broader 510(k) program predates Menaflex scrutiny, however.

"The 510(k) process is a loophole that has swallowed the law," Lurie told "The Gray Sheet" in 2007, when he was advocating for 510(k) reform as part of an effort to reauthorize FDA user fees under the FDA Amendments Act (The Gray Sheet' July 16, 2007).

"What we'd like to see come out of this are two things that are related to one another," he said at the time. "One is the 510(k) process would be used less often and that more products would go through the PMA process, and the second is that this provision whereby you can have a device called substantially equivalent even without using the same technology would be scrapped."

The FDA Amendments Act of 2007 included an order for the Government Accountability Office to further evaluate the 510(k) process; GAO's report came out earlier this year (The Gray Sheet' Jan. 19, 2009).

More recently, Lurie testified in June at a House Energy and Commerce Subcommittee hearing that CDRH could go a long way on its own, without statutory changes, to boost device pre-market review standards (The Gray Sheet' June 22, 2009).

Lurie has also been a regular attendee at device advisory panel meetings, presenting Public Citizen's critiques of specific product applications.

For instance, he spoke out against PMA approval for Covidien's DuraSeal Xact dural repair sealant for spine surgery at a May advisory panel hearing, noting that "it remains unknown whether DuraSeal produces a clinically meaningful benefit" (The Gray Sheet' May 18, 2009). The panel voted 4-0 to recommend approval of the device, which FDA granted in September.

On behalf of Public Citizen, Lurie also has called for more vigorous government regulation of laboratory-developed genetic tests, more restrictions on direct-to-consumer advertising for FDA-regulated products and less reliance on FDA advisory panel members with conflicting financial interests.

More Slots Are Filled On FDA's Staffing Chart

The Oct. 16 memo announcing Lurie's appointment also identifies several additional recent hires at FDA:

Ann Witt, who has spent the past six years as counsel to Rep. Henry Waxman, D-Calif., has returned to FDA, reprising her previous role as counselor to the deputy commissioner on policy.

John Taylor, another former FDAer, was hired back to fill the newly created position of counselor to the FDA commissioner. Taylor has been executive VP for health at the Biotechnology Industry Organization since 2007 and before that was VP of federal government affairs at Abbott.

Prior to joining industry, Taylor worked at FDA for 14 years, rising to the post of associate commissioner for regulatory affairs. In his new position he will be charged with developing crisis management procedures and coordinating counterterrorism efforts, among other responsibilities.

Jeanne Ireland is joining the agency to head the Office of Legislation. She was most recently chief public health policy advisor to Rep. John Dingell, D-Mich., and had worked for Sen. Chris Dodd, D-Conn., before joining the Elizabeth Glaser Pediatric AIDS Foundation.

Meghan Scott will serve as FDA's chief press officer; she was campaign director of Wake Up Walmart, a project of the United Food and Commercial Workers International Union, and prior to that was communications director for the American Association of Justice.

Vicki Seyfert-Margolis will serve as an advisor to FDA Acting Chief Scientist Jesse Goodman, with a focus on bioinformatics. Seyfert-Margolis was most recently chief scientific officer at Immune Tolerance Network, a non-profit consortium of researchers seeking new treatments for diseases of the immune system. She was also a program director in innovative scientific research at the National Institute of Allergy and Infectious Diseases at NIH.

- David Filmore and Ramsey Baghdadi

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