Crawford: The new boss at FDA.

In July, following a contentious hearing process, the U.S. Senate finally confirmed Lester M. Crawford, DVM, PhD, as permanent FDA commissioner. President Bush nominated Crawford to the top spot at the agency in March, but the confirmation was delayed for five months by a bipartisan group of congressional critics who questioned Crawford’s leadership on a number of issues, including drug safety and approval, policy enforcement, agency staffing, and fiscal management.

Crawford, 67, is a veterinarian and food-safety expert with a doctorate in pharmacology. He has held the title of acting FDA commissioner since March 2004 when the former

head of the agency, Mark McClellan, left to head up the Centers for Medicare and Medicaid Services (CMS; Baltimore). Crawford was named deputy commissioner in February 2002 and also served as acting commissioner prior to McClellan’s appointment in November 2002.
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Just days before their August break, the House and Senate passed legislation to ensure the continuation of the Medical Device User Fee and Modernization Act of 2002, which was initially signed into law to provide FDA with greater resources for the timely review of devices submitted for approval. Without Congressional action to modify provisions of the original user fee act, the law would have likely expired on September 30 of this year.

The new bill, known as the Medical Device User Fee Stabilization Act of 2005, was signed into law by President Bush on August 1.

Many medtech manufacturers have expressed support for the concept of user fees to speed up the approval process. But some have continued to question the value of the program, especially in light of rising costs and FDA’s difficulty in meeting its performance objectives. The early take on the user fee stabilization act is that it’s a good start at addressing industry’s major concerns. [ More ]

After recalling more than 100,000 of its implantable cardiac defibrillator (ICD) devices in June, Guidant Corp. (Indianapolis) has now issued a voluntary recall of approximately 28,000 pacemakers. In mid-July, the company notified physicians, patients, and FDA that there was a potential safety flaw in some of its pacemaker models manufactured between November 25, 1997, and October 26, 2000. The flaw was attributed to the hermetic sealing component used in the devices, which could result in higher than normal moisture content and potentially cause an abnormal pacing condition.

A great deal of attention remains focused on Guidant’s pending $25.4 million acquisition by Johnson & Johnson Inc. (New Brunswick, NJ).

Guidant CEO Dollens: A deal in trouble?

In July, the Institute of Medicine (IOM; Washington, DC) issued a report sharply criticizing FDA’s ability to track the performance and safety of medical devices following their market introduction. Although the report, Safe Medical Devices for Children, was the culmination of a two-year study that focused primarily on medical devices for the pediatric population, the authors state that their findings readily apply to all devices and age groups.

The IOM committee on postmarket surveillance of pediatric devices found the most obvious deficits in FDA’s performance to be "a lack of effective procedures for monitoring the status of required postmarket studies

and the lack of public information regarding such studies." Committee chair Hugh Tilson, MD, DPH, said, "The system needs to be public, transparent, and understandable, with less secrecy and more openness in the sharing of information." Tilson is senior advisor to the dean and clinical professor of epidemiology and public policy at the University of North Carolina School of Public Health (Chapel Hill, NC). [ More ]

Following a protracted and at times contentious product review process, Cyberonics Inc. (Houston) last month received notification from FDA that the company had received final approval to market its Vagus Nerve Stimulation (VNS) device for treatment-resistant depression (TRD). The VNS device was actually approved for TRD in February, but FDA stipulated that the device could not be marketed for that indication until the company had addressed agency concerns about its manufacturing operations, product labeling, and other issues.

Commenting on FDA’s decision to approve the VNS device for TRD, Robert Cummins, CEO of Cyberonics, said, "Today for the first time, Americans with treatment-resistant depression have an FDA-approved, informatively labeled, long-term treatment option for their lifelong and life-threatening illness." Cummins speculated that the brain and neuromodulation will be the next frontier for medical devices, and will attract extensive research and product-development activities similar to those now being devoted to the heart and cardiac-rhythm management. [ More ]

Industry association AdvaMed (Washington, DC) has selected Stephen J. Ubl as its new president and CEO. Current AdvaMed chairman Art Collins, chairman and CEO of Medtronic Inc. (Minneapolis), made the announcement of Ubl’s appointment in the middle of July. Ubl succeeds Pamela Bailey, who left the organization in March of this year to head the Cosmetic, Toiletry, and Fragrance Association (CTFA; Washington, DC).

Ubl formerly served as AdvaMed’s executive vice president for government relations from 1998 until last year, when he left to form his own healthcare consulting firm, Ubl Health Solutions LLC (Washington, DC). A graduate of St. Cloud State University (St. Cloud, MN), he began his work on Capitol Hill as a special assistant to Senator Charles Grassley (R-IA), and was

subsequently vice president for legislation at the Federation of American Hospitals (Washington, DC) before assuming his previous position with AdvaMed in 1998.
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