Medical Device Daily Associate Managing Editor
Waiting until the waning hours of a lame duck session of Congress, the Senate finally confirmed Andrew von Eschenbach, MD, as commissioner of the FDA late on Thursday, filling an important post that has been vacant since the abrupt resignation of Lester Crawford in September 2005.
Dr. von Eschenbach, 65, a surgeon, became acting commissioner in September 2005 after the surprising resignation of Lester Crawford, MD (Medical Device Daily, Sept. 27, 2005) — just two months after his own confirmation to the post. Previously, he had served as chief academic officer at theM. D. Anderson Cancer Center (Houston) and had led the National Cancer Institute
Crawford resigned from the post amid questions about discrepancies in his financial disclosure forms. Crawford pleaded guilty in October to federal misdemeanor charges of lying on those forms about stock holdings in companies regulated by the agency.
The head position at the FDA has been a difficult one to keep staffed, particularly over the last decade. In the past 10 years, no commissioner has served more than two years. That’s clearly due in part to the myriad of political forces seeking to pull strings at the agency.
A report released in September by the Institute of Medicine (Washington), part of the National Academies, deplored a “lack of stable leadership” at the agency. The report said that turnover at the helm would compromise efforts to improve the effectiveness of the agency, which the report criticized as rife with internal squabbles, poor management and outdated rules.
Dr. von Eschenbach was formally nominated to the position of commissioner in March by President Bush (MDD, March 17, 2006), but his confirmation was delayed by a series of objections in the form of “holds” by senators from both parties who said they were protesting everything from the agency’s delay of Plan B emergency contraceptives to the administration’s stance on drug reimportation, or the purchase of prescription drugs in countries where they are cheaper.
By Senate tradition, any member may delay a nominee through a hold, but the majority leader has the discretion to ask the Senate to override it in a procedure called cloture.
Before delivering a farewell speech on Thursday on the Senate floor, Sen. Bill Frist (R-Tennessee), the retiring majority leader, called for a procedural vote to bring von Eschenbach’s name before the full Senate for confirmation, ignoring remaining holds from three fellow Republicans.
Frist, himself a cardiac surgeon before he joined the Senate, said von Eschenbach had done a “superb” job as acting commissioner.
Dr. von Eschenbach’s confirmation, by a vote of 80 to 11, came despite the strong objections of powerful Sen. Charles Grassley (R-Iowa) who has been an outspoken critic of the agency.
“A vote for this nominee would be an endorsement of the stonewalling and disrespect he has shown for congressional oversight,” Grassley said in one of several speeches that he delivered during the day.
Grassley had placed a hold on von Eschenbach’s nomination, accusing him of refusing to turn over evidence needed for a Senate Finance Committee investigation of an antibiotic, Ketek, that is manufactured bySanofi-Aventis (Paris).
Ketek was approved in 2004 despite the misgivings of employees at the drug agency. It has since been linked to liver problems and deaths. The FDA has scheduled advisory panel hearings for next week on whether to keep it on the market.
Former employees of the agency have told Grassley, who leads the finance committee, that von Eschenbach held a meeting in which he hinted that they would be retaliated against, or be “off the team,” if they discussed their complaints about Ketek outside the agency. Von Eschenbach has said he did not intend the comments as a threat.
“The American people don’t want the government making decisions about what’s good for them behind closed doors,” Grassley added.
In addition to Grassley, Sens. David Vitter (R-Louisiana) and Jim DeMint (R-South Carolina) had placed procedural “holds” on von Eschenbach’s nomination that had to be overcome through the cloture vote.
Vitter’s complaint is that the FDA will not allow U.S. consumers to buy prescription drugs from Canada. The FDA says it cannot ensure the safety of drugs sold in other countries. DeMint wants sales of the abortion drug RU-486 suspended and its safety re-examined.
In addition to Grassley and Vitter, Sens. Rick Santorum (R-Pennsylvania), George Voinovich and Mike DeWine (both R-Ohio) and Max Baucus (D-Montana) voted against invoking cloture, for which 60 votes are required. DeMint voted for cloture but against confirmation.
Sen. Michael Enzi (R-Wyoming) who heads the Health, Education, Labor and Pensions Committee, urged von Eschenbach’s confirmation, citing the need for a permanent leader.
“The FDA has been without a confirmed commissioner for all but 18 months of the last five and a half years,” Enzi said. “Ever see a business that could run for five and a half years without a boss except for 18 months?”
The Advanced Medical Technology Association ’s(AdvaMed; Washington) President/CEO Stephen Ubl told Medical Device Daily that his organization was particularly excited about von Eschenbach’s appointment.
“He’s a dynamite choice [for the FDA post],” Ubl said. “For one thing, he’s got first hand experience with medical technology as a urologic surgeon and then his work with the National Cancer Institute with imaging technologies. It’s been a while since we’ve had an FDA commissioner with that level of familiarity with the [medical device] industry.”
Given the transitory nature of recent appointees at the position, Ubl’s belief that von Eschenbach ‘[w]ill finish out the Bush administration” should be welcome news to all involved in the healthcare industry.
In particular, he said Sen. Frist deserves “an enormous amount of credit for moving this forward in the face of significant opposition.” He also noted that Congress is more receptive to getting things done sometimes near the end of a legislative session, equating their eagerness to leave to schoolkids awaiting a play break. “When it gets close to recess, they want to go.”