Von Eschenbach has been confirmed as FDA commissioner, but he will have to restore FDA's damaged reputation.
After a nomination that had been on hold for months, Andrew von Eschenbach, MD, was sworn in as FDA commissioner on December 13. While the presence of a permanent commissioner is significant, it might not have a direct effect on the daily operations at CDRH.
Von Eschenbach's nomination was delayed as a result of controversies, mainly in the drug arena. Senators Hillary Clinton (D–NY) and Patty Murray (D–WA) worked to hold his nomination over the emergency contraceptive, Plan B. Von Eschenbach took heat from Senator David Vitter (R–LA), because Vitter wanted to legalize the importation of prescription drugs. Senator Jim DeMint (R–SC) also put a hold on von Eschenbach's nomination in efforts to push FDA to stop the sale of an abortion drug.
Majority Leader Bill Frist (R–TN) put an end to the dispute by calling for a procedural vote, which resulted in an 80–11 approval for von Eschenbach's confirmation.
The permanent FDA commissioner will now have to deal with concerns about postmarket surveillance of both drugs and devices, which have afflicted the agency in recent years. Jonathan Kahan, partner at Hogan & Hartson (Washington, DC), notes that von Eschenbach can't avoid involvement with postmarket safety issues on the drug side, but he'll probably leave more of the responsibilities related to devices, including postmarket surveillance, up to CDRH director Dan Schultz.
Larry Pilot, partner at McKenna, Long & Aldridge LLP (Washington, DC), adds that von Eschenbach must restore the agency's reputation with the help of others at FDA. Von Eschenbach began serving as acting commissioner after Lester Crawford's sudden resignation in September 2005. Crawford pleaded guilty last October to conflict-of-interest charges related to stock holdings (see “Ethical Breaches Hurt Device Industry's Reputation” on page 76). And in light of highly publicized controversies involving drug safety and device recalls, FDA's reputation has taken a hit.
With the resignations of Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, and Patrick Ronin, FDA chief of staff, von Eschenbach will also be challenged to select the right people for management positions. “He has to do it through competent supervisors and subordinate supervisors. The test for him is going to be how well he's able to take advantage of the position that he's in and restore what the agency appears to have lost in the context of reputation and image,” says Pilot. (In late December, von Eschenbach named Randall Lutter to replace Gottlieb on an acting basis.)
While having a permanent commissioner is beneficial to the industry, there's also speculation that von Eschenbach won't remain at the FDA post for long. “I believe he's a 24-month commissioner. I think everybody in the world believes that,” says Kahan. “He's a friend of the Bush family. Even if a new Republican candidate came in, von Eschenbach would resign.”
Kahan adds that the absence of a long-term FDA commissioner who's willing to defend initiatives makes it difficult for the agency to take a tough stance on issues. “I think it has an effect on morale at the agency and the ability of senior management at FDA to take a strong new direction on anything.”