New leader for FDA in turmoil
pharmafile | September 30, 2005 | News story | Sales and Marketing |
Andrew von Eschenbach has been appointed the new acting head of the FDA after the surprise resignation of Lester Crawford.
Crawford had spent over three years as deputy commissioner, then acting commissioner before finally being made FDA commissioner in July this year, only to resign weeks into the job.
The 67-year-old had spent 30 years in various posts at the US regulator, and his sudden resignation hints at a troubled atmosphere at the FDA which has been badly criticised for its handling of a number of issues.
Most notable among these were the safety scares over antidepressants and Vioxx, but agency morale was hit once again in August when Crawford indefinitely postponed the sale of the 'Plan B' emergency contraception over the counter, overruling the advice of FDA scientists.
Susan Wood, the FDA's assistant commissioner for women's health chief resigned in protest, saying in an e-mail to staff: "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
Wood – who was herself criticised by conservative groups opposed to the contraceptive's launch – said: "Many colleagues have made it known that they are deeply concerned about the direction of the agency."
Charles Grassley, chairman of the Senate finance committee which investigated the FDA over Vioxx, welcomed Crawford's departure.
"In recent years, the FDA has demonstrated a too-cosy 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."
The head of one interest group, Michael Jacobson of the Center for Science in the Public Interest, praised the departed commissioner. He applauded Crawford's openness and said his departure would be a blow for the regulator.
"The agency has had so much turnover in the top spot, and turmoil throughout, that it could have benefited from a period of steady leadership," said Jacobson. "The country doesn't need a rudderless FDA," he added, concluding: "We hope the next commissioner is able to assert the agency's independence from the kinds of political and corporate pressures that have rendered the agency ineffective on many fronts."
Andrew von Eschenbach has been appointed as the acting commissioner from his role as director of the National Cancer Institute, where he served for nearly four years.
Von Eschenbach is a practising urologist and research scientist, and had built up a strong reputation at the Cancer Institute, surviving three separate cancer diagnoses himself.
Speaking about his new role, which remains unconfirmed as a permanent position, he said scientific advances had to be balanced with patient safety at all times.
"I believe very strongly that science has to drive and is the driver of our knowledge and our understanding, and therefore of our decisions," he told Associated Press. "Where science is incomplete, we continue to believe that under any circumstances, do no harm."
He reiterated the explicit drive to cut approval times, saying: "I believe it's still important to ask the question: 'How can we accelerate the timeline? How can we make certain we are getting these interventions to the patients as quickly as possible?'"
Despite the industry-friendly noises, the new commissioner is also likely to pursue reforms to open up FDA decision-making and drug information to the public.
Crawford had already proposed changes in the wake of the Vioxx investigations, including posting information about drug side-effects on an FDA 'Drug Watch' website, a move which the US industry is opposing.
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