Medical Device Daily Washington Editor

FDA's handling of the Menaflex 510(k) continues to draw unwanted attention to both the agency and the sponsor, ReGen Biologics (Franklin Lakes, New Jersey), this time because of a March 6 letter from Sen. Chuck Grassley (R-Iowa) asking about correspondence between the firm and FDA in regard to an advisory committee hearing last year on the firm's application for a collagen scaffold.

ReGen managed to obtain an informal assent from the orthopedic and rehabilitative devices advisory committee in November (Medical Device Daily, Nov. 18, 2008) for the Menaflex 510(k), but things have grown more complicated for the firm since that time.

An article appearing in the Wall Street Journal last week noted that FDA e-mails indicated that ReGen had a hand in selecting several temporary voting members for the hearing, but the company's position is that reviewer bias made extraordinary measures necessary in order to get a fair shake for the application.

Grassley's March 6 letter to acting FDA Commissioner Frank Torti states, "as I have said in the past, I am concerned about the cozy relationship that sometimes exists between FDA and manufacturers," and he expressed interest in "the former FDA commissioner's personal involvement."

He requested that the agency supply his office with information on why ReGen was able to offer input on the composition of the advisory committee, assuming this is not ordinarily the case, and asked for details on how the commissioner "would become personally involved in the convening of an FDA advisory panel."

Grassley also has asked ReGen for copies of all correspondence between it and FDA, between ReGen and any third parties, and any internal company communications on the advisory panel situation. The Grassley letter also notes that ReGen objected to attendance at the meeting by Dan Schultz, MD, chief of the Center for Devices and Radiological Health, but Schultz actually proctored the meeting.

In his March 6 letter, Grassley asked the company "to explain in detail why ReGen thought that Dr. Schultz was biased against" the application.

In an interview last week with Medical Device Daily, ReGen's VP for regulatory affairs, John Dichiara, said the company filed an investigational device exemption for the product in 1992 which made the application a PMA but at least one other firm ended up beating the Menaflex through the PMA route, which was followed by a number of predicates.

The company complained that while ReGen refiled the application as a 510(k) in 2005, FDA reviewers seemed inclined to view the application as a PMA, requesting more data than was offered for a similar device used in spinal applications. Dichiara told MDD that reviewers continually threw up "a moving target of objections" to the application.

In a statement e-mailed to MDD, Gerald Bisbee, MD, the company's chsirman/CEO, said the company "received a request for information from Senator Grassley and we intend to respond to it."

FDA officials were not available for comment.

FDA waits 18 months on panel nod

If industry likes to grumble about FDA's torpid device approval process, some companies at least have a decent case to make.

The agency has promised to turn around the majority of PMAs in 180 days or less, but FDA needed well in excess of 500 days to act on an advisory panel's recommendation of approvability for the Repel CV, an anti-adhesion barrier for use in pediatric cardiac surgery. The Repel, made by SyntheMed (Iselin, New Jersey), was the subject of an advisory committee meeting that took place in September 2007 (Medical Device Daily, Sept. 21, 2007), but the company got the green light from FDA only this week.

The average age of patients in the pivotal trial for the Repel PMA was 12 days, and the device is indicated for patients likely to need a second operation, which for some neonates with congenital heart defects is not uncommon. FDA reviewers said during the panel hearing that while the data showed a 26% reduction in adhesions, some center effect was seen. The panel recommended that the product's label indicate its use in patients aged 20 or younger (the Center for Devices and Radiological Health sees adults as those aged 21 and older whereas the Center for Drug Research and Evaluation typically uses the age of 18 as a cut-off).

The age-related indication must have stuck because according to wire service reports, Robert Hickey, president/CEO of SyntheMed, said the firm is "engaged in discussions with FDA personnel to define the clinical data required to expand the use of Repel CV to include adult cardiac surgery patients."

The company obtained a CE mark in 2006 and nailed down approval for sale in Canada in July 2008.

FDA, academe to get really small

Comedian Steve Martin may or may not have been channeling physicist Richard Feynman when he unveiled his stand-up routine about getting together with the like-minded and "getting really small" on a 1977 record album, but FDA and several academic research centers intend to do just that in the coming years.

According to a March 10 statement, FDA "unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth and its eight member institutions to help speed the development of safe and effective medical products in the emerging field of nanotechnology." The statement notes that the plan, part of the Critical Path Initiative, will combine efforts with a number of Texas-based academic centers, including M.D. Anderson Cancer Center (Houston) and the University of Texas Medical Branch (Galveston, Texas).

Acting FDA Commissioner Frank Torti said in the statement that the collaboration "is a clear example of leveraging science and scientists to advance the public good."

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