Originally Published MDDI October 2005
EDITOR'S PAGE Political Fallout Knows No Bounds
Change at FDA, starting with leadership, is coming. The device industry may not bear the brunt of it, but some effect is certain.
Political Fallout Knows No Bounds
The resignation of Lester M. Crawford, DVM, PhD, as FDA commissioner in September leaves a leadership void at the embattled agency. But how much does it matter for device companies?
In the short run, probably not much. Under Crawford, CDRH director Daniel Schultz had been given a lot of leeway to run the center as he saw fit. It is reasonable to expect that Crawford's temporary replacement, Andrew C. von Eschenbach, MD, will give Schultz a similarly wide berth. Von Eschenbach's background is not in devices, and aside from the much-publicized problems with implantable cardiac defibrillators, FDA's biggest crises lie elsewhere.
“Crawford had not been involved in medical device issues to any significant degree,” says Jonathan Kahan, partner at Hogan & Hartson LLP (Washington, DC). “Most of what went on came out of CDRH, with HHS pretty much signing off on all of it. So I don't think there will be much of a direct effect.”
Indeed, while the agency's upper management has been accused of playing politics in the pharmaceutical arena, that has not been the case in the device sector. Schultz has shepherded his staff through a number of controversial decisions, including approvals of silicone breast implants and neurostimulation treatment for depression, without much political fallout. “It's helped that these were, in my opinion, the correct stands, and Schultz has also been right on with regard to postmarket reviews and MDRs,” says Kahan.
In the long run, however, a lack of leadership will frustrate industry. The absence of a permanent commissioner hinders the agency's ability to make policy changes of any significance. An acting commissioner doesn't have a mandate to put his or her stamp on the agency, so attempts at major change can be interpreted as making waves just for the sake of doing so. “It's the disarray that will have an effect,” says Kahan.
And let's not kid ourselves; major changes are likely in store for the agency. It is unlikely that it will revert to the Kessler-era attitude of being adversarial to industry. Laws passed in the intervening years pretty much prevent that. But without the appropriate expertise at the agency's highest ranks, ill-considered reforms that hamper patient access to new technology could take hold.
It is enough of a challenge that “some consider [FDA] to be an unmanageable agency,” says Larry Pilot, a partner at McKenna, Long & Aldridge LLP (Washington, DC). What could compound the problem, he says, is that several key positions at the top of the agency aren't held by people with much experience with the legal or regulatory issues affecting the industries regulated by FDA.
“I consider the top spots in terms of managing the agency to be the commissioner, the head of the Office of Regulatory Affairs, and the chief counsel,” says Pilot. “[Associate Commissioner for Regulatory Affairs] Margaret O'K. Glavin has been with FDA for a few years, but she has no real field or legal experience. The new chief counsel [Sheldon T. Bradshaw] and his deputy are relatively new to food and drug law. And I don't believe von Eschenbach has any experience with the agency. These three positions are occupied by people without a lot of institutional experience. Of course there are subordinates they can rely on, but the top three are virgins in the field,” says Pilot. “This situation is without precedent. FDA has never been in a position like this with regard to management strength and public visibility. Without that experience, it's going to be hard to move the ship in a direction likely to please all stakeholders, none of whom seem to be in FDA's corner right now. Will there be political fallout? Absolutely.”
Even though CDRH has strong leadership, don't expect it to be immune from such fallout. When the agency undergoes reforms in response to public and political pressure, change tends to occur across the board. Device companies will need to do the best they can to anticipate what forms this may take.
Erik Swain for the Editors
Copyright ©2005 Medical Device & Diagnostic Industry