FDA’s Crawford Resigns

Crawford: Stepping aside.

FDA Commissioner Lester M. Crawford, DVM, PhD, resigned his post suddenly on September 23, only two months after his final confirmation as permanent head of the agency. In his place, President Bush named Andrew C. von Eschenbach, MD, director of the National Cancer Institute, as acting FDA commissioner.

Few details were provided surrounding the resignation, which was effective immediately. Numerous reports cited Crawford as telling his staff that, at age 67, it was simply time to step aside. His confirmation and tenure at FDA, however, were far from tranquil. 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 came under fire for FDA’s allegedly slow response to drug-safety issues involving antiarthritis Cox-2 inhibitors such as Vioxx and Celebrex, antidepressants prescribed for children, and dietary supplements like ephedra.

Last month, Crawford indefinitely postponed nonprescription sales of Plan B—the so-called “morning after” emergency contraceptive drug. Subsequently, FDA’s women’s health chief resigned.

Grassley: Demanding new direction.

Senator Charles Grassley (R–IA) was one of Crawford’s most vocal critics during the confirmation process. Shortly after Crawford announced his resignation, Grassley issued a statement reading, “In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information. The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction. Now is the time to reform the FDA’s culture and reassert that the agency’s top priority is what’s good for John Q. Public when it comes to reviewing drugs in the marketplace and making new miracle medicines available. FDA scientists and employees are by and large hard-working and committed to fulfilling the agency’s mission. They deserve a commissioner who will reinvigorate the agency.”

Kimbell: Tracking leadership changes.

Despite criticisms, some say Crawford and other FDA officials wrongly bear the brunt of issues beyond their control. “Those of us who lobby in the medical technology space are always closely monitoring the swinging regulatory pendulum at FDA—as is Congress and the administration,” says Jeff Kimbell, who is principal of Jeffrey J. Kimbell & Associates (Washington, DC) and served on President Bush’s transition team advisory committee for the U.S. Department of Health and Human Services in 2001. “The leadership at FDA understands its mandate to protect patient health, and generally speaking they’ve done it extremely well over the years.”

Crawford, a veterinarian and food-safety expert with a doctorate in pharmacology, had worked at FDA in various capacities over the years. He took the title of acting FDA commissioner in March 2004 when the former head of the agency, Mark McClellan, left to head up the Centers for Medicare and Medicaid Services (Baltimore). Crawford was named deputy commissioner in February 2002 and also served as acting commissioner prior to McClellan’s appointment in November 2002.

Overall, the medtech industry had welcomed Crawford’s nomination as commissioner. “MDMA has enjoyed a very good working relationship with Dr. Crawford,” says Chris Delporte, director of member relations and communications at the Medical Device Manufacturers Association (MDMA; Washington, DC). “We wish him well in his future endeavors.”

AdvaMed’s Ubl: Optimism seeking stability.

“At some level, it’s obviously disappointing to lose stable leadership in the commissioner’s office,” says Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC). “But we’re optimistic about the nomination of Dr. von Eschenbach.”

Von Eschenbach, a nationally recognized urologic surgeon who is himself a cancer survivor, accepted his appointment to lead the NCI in January 2002. Prior to that, he served as executive vice president and chief academic officer of the University of Texas MD Anderson Cancer Center (Houston). At MD Anderson, he also served as vice president for academic affairs and held the clinical research distinguished chair in urologic oncology.

Von Eschenbach: Experience with medtech.

In 2002, von Eschenbach participated in an educational briefing, sponsored by the National Dialogue on Cancer and AdvaMed, on cancer research and the role of new technology in diagnosis and treatment. “He’s obviously had firsthand experience with medical technology,” Ubl says. “And philosophically, he has shown a refreshing attitude toward really looking at the premarket side of the approval process and being vigilant in examining all avenues to make sure patients have access to the treatment they need.”

The president and CEO of the Biotechnology Industry Organization (Washington, DC), James C. Greenwood, also heralded the appointment, saying, “Dr. von Eschenbach’s role as the director of the National Cancer Institute affords him unique insights into the critical need to advance new treatments for patients with life-threatening illnesses. As a teacher and academician, he understands the importance of education and research to reach these scientific breakthroughs. Also, through his work with the American Cancer Society, he knows the vital role that patient advocates provide in advancing medical research.”

Whether von Eschenbach will move into the role of permanent commissioner remains to be seen. In identifying qualifications likely to be sought in a permanent FDA commissioner, Kimbell lists three criteria: an advanced degree in science or medicine, experience in managing a major organization, and an ability to get through the often-brutal Senate confirmation process. Von Eschenbach, he says, meets all three measures.

Although the major controversy that surrounded Crawford revolved around drug safety, Kimbell says device manufacturers must still pay close attention to the leadership changes within FDA. “Congress has been very interested and involved in FDA’s activities in light of the recent drug recalls, such as the recall of Vioxx,” says Kimbell. “Although Congress is initially focusing on drug safety, devices could easily become part of the debate. FDA needs a strong leader to address Congress’ and the public’s concerns about safety from all aspects.

“Because of the nature of technology development in the 21st century, and the way in which drugs and devices are being used in combination more regularly (evidenced by the establishment of the Office of Combination Products), the device industry must pay close attention to its sister industry, which is more experienced and arguably more Washington-savvy,” Kimbell adds. “If FDA tightens the reigns on pharmaceuticals, devices probably won’t be far behind.”

In spite of recent criticism of FDA, however, achieving meaningful changes in the way that the agency regulates industry could be difficult in the coming months. And even FDA work under way to implement internal reforms could stall out while the agency awaits the appointment of a permanent commissioner. “In my opinion, nothing dramatic can happen without a true leader,” says Kimbell. “But the business of FDA continues on, and should.”

Canon Communications LLC

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