Von Eschenbach a step closer to confirmation
Although acting FDA Commissioner Andrew von Eschenbach, MD, has been on the job since September 2005, it was only last month that he received approval from the Senate's Health, Education, Labor, and Pension (HELP) committee for his nomination as FDA commissioner to be considered by the full Senate. However, the step was an incremental one at best for Dr. von Eschenbach and the agency, which has been without an officially appointed commissioner for all but 18 months over the past 5 1/2 years.
"We need a strong leader at the FDA right now, one who has a mandate to act," said Sen Mike Enzi (R-Wyo), head of the HELP committee, after the committee's unanimous vote of approval. "There are many items before the FDA that require the immediate attention of an FDA commissioner vested with full authority. It is time for the Senate to move forward with this nomination."
Despite Sen. Enzi's urging for a quick consideration of the nomination by the full Senate, a pair of Republican senators, David Vitter of Louisiana and Jim DeMint of South Carolina, have threatened to once again place a hold on Dr. von Eschenbach's approval, this time over issues surrounding the importation of drugs from overseas and the safety of medical abortion with mifepristone and misoprostol (RU-486). These new concerns have made it less certain whether a vote on Dr. von Eschenbach's nomination will occur before November's midterm elections.
"This is all going to depend on the leverage the leadership has over these 2 senators and to the extent that they (the senators) cooperate and relent," said Marc Scheineson, JD, LLM, a former FDA associate commissioner for legislative affairs and head of the food law practice of Alston & Bird in Washington, DC. "What they're proposing has actually no basis in law--you can't withdraw a product like RU-486 or a product that's already been approved unless it's been determined to be unsafe or not effective. There will be great pressure on those senators to relent."
FDA received reports in March of 2 deaths following medical abortions with mifepristone and misoprostol. One of those deaths was found by FDA to be unrelated to the use of mifepristone and misoprostol, whereas the other is still under investigation. A determination has not been made about whether the use of mifepristone and misoprostol for medical abortion played any role in causing the deaths of 4 women that were previously reported by FDA.
Politics already have played a role in the delay of Dr. von Eschenbach's nomination while in the HELP committee, in part because Democratic senators criticized FDA's treatment of over-the-counter availability for Plan B. The Plan B controversy was said to have been a main catalyst for the departure of Dr. von Eschenbach's predecessor, Lester Crawford, DVM, PhD, who served just 2 months as FDA's fully approved commissioner before stepping down.
Such political wrangling involved in approving a new FDA head has become more common and has interfered with the agency's mission and its ability to fulfill its functions as the nation's food and drug safety watchdog, according to Scheineson.
"There's a good argument for why an FDA commissioner shouldn't be a confirmed position anyway," Scheineson said. "The protection for any commissioner is to base decisions on sound science and try to keep politics on the sideline as long as possible."
The delays in his nomination's approval and the caveat of being an "acting" commissioner have not hindered some FDA efforts under Dr. von Eschenbach, who was previously director of the National Cancer Institute. Beyond the agency's Plan B decision, FDA in the last year has refocused its enforcement efforts on unapproved medications, issued rules on revised labels, and taken steps to reform the drug approval process, particularly in the area of changing from a paper-based to an electronic system to handle new product submissions and to track postmarketing data.
"They've found an exceptional candidate in this case who has proven management and substantive experience. They couldn't find a better guy, so they want to keep him engaged and not frustrated," Scheineson said.