Medical Device Daily Washington Editor

The wires were abuzz yesterday with the announcement that Dan Schultz, MD, director of the Center for Devices and Radiological Health at FDA, is reported to have turned in his resignation "by mutual agreement" with the new leadership at FDA.

According to a breaking story in yesterday's online edition of the Wall Street Journal, Schultz reported the move in a letter to CDRH employees in which he stated that his decision was "based on discussions with Commissioner [Margaret] Hamburg." The WSJ story also indicated that the departure "had nothing to do with any specific issue related to a device's approval process," although the intensity of the recent flap over the approval of the Menaflex 510(k) application by ReGen Biologics (Franklin Lakes, New Jersey) makes the claim seem questionable.

There has also been a more general controversy over the 510(k) program, which hit the nation's media thanks to letters from disgruntled employees to congressional leaders and the Obama administration. One of those letters also named the director of the Office of Device Evaluation, Donna-Bea Tillman, PhD, in allegations that she and Schultz placed relations with industry over safety considerations. According to a May letter from the renegade reviewers to Joshua Sharfstein, MD, at the time the acting commissioner at FDA, Schultz and Tillman seemed "far more concerned about ensuring their current positions and protecting and promoting their own careers and those of their cronies than they are about ensuring the safety and effectiveness of medical devices."

Schultz is said to have approved the Menaflex 510(k) while Tillman is said to have opposed the clearance. Among those whose role in the Menaflex clearance was seen as pivotal is Rep. Frank Pallone (D-New Jersey), chairman of the health subcommittee for the House Energy and Commerce Committee, which has spearheaded an effort to put the brakes on the 510(k) program.

Medical Device Daily obtained an all-hands e-mail posted at FDA by Hamburg in which she thanked Schultz "for his long service to the agency and to the public." Hamburg added that Schultz "has worked tirelessly to advance the public's health through the approval and monitoring of innovative and safe medical devices."

The new commissioner said that under Schultz's leadership, "CDRH enhanced our understanding of the risks and benefits of using medical devices in pediatric populations, increased the agency's safety efforts by expanding MedSun, and led the agency in the Postmarket Transformation process, which has provided an opportunity to fundamentally rethink the way risk/benefit information is collected, analyzed, and executed." She said the physician "has left a tremendous legacy, and we wish him well in all his future endeavors."

Hamburg also reported that Jeffrey Shuren, the agency's associate commissioner for policy and planning, will serve as the interim director of CDRH. Hamburg said Shuren "has a deep understanding of medical device law and policy" and that the agency will commence with "a national search for the position of director of CDRH."

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington) told MDD in an e-mail; "MDMA has appreciated working with Dr. Schultz over the years to provide patients with timely access to safe and effective products and wish him the best."

Steve Ubl, President/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said in an Aug. 11 statement that Schultz "served the nation for more than 30 years" and that he "supervised FDA's device center at time of unprecedented scientific advancement and helped continue U.S. leadership in the development of safe and effective medical treatments."

Ubl remarked that Schultz "was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees" and "launched CDRH's Postmarket Transformation Initiative." The statement also notes Schultz's leadership "in efforts to strengthen and harmonize global medical device regulatory requirements."

Not all the reactions were positive. Diana Zuckerman, PhD, President of the National Research Center for Women and Families (Washington) told MDD in an e-mail that she sees it as "essential that the FDA's new leadership expands beyond the FDA Commissioner and Deputy Commissioner, and Dr. Schultz' resignation is a crystal clear sign that the process of reinvigorating a more public-health oriented FDA has begun." Zuckerman added that the change "is especially important to baby boomers, who increasingly rely on implants such as artificial knees and heart valves, as well as cosmetic injections such as wrinkle fillers, many of which have been allowed to be sold without adequate safety testing."

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com