Originally Published MDDI April 2005
Device Industry Adopts Wait-and-See Policy Regarding Crawford Appointment
|Industry wants to know how Commissioner Lester Crawford will approach user fees and other issues.|
Although the device industry welcomes Lester Crawford as permanent FDA commissioner, many of its leaders don't think the move will have a significant effect on industry—at least not right away. That could change depending on what happens with upcoming negotiations on how to improve the user-fee program.
Under pressure to reform FDA after concerns about drug safety hit the news, President Bush appointed Crawford to the job permanently. Crawford was serving in his second stint as the agency's acting commissioner. At press time, the Senate had not yet voted on confirmation, though approval was expected. (For more on Crawford, see “Washington Wrap-Up,” p. 34.)
“I don't think his selection is either good or bad for the device industry. It depends on how he's affected by all the baggage that he brings with him,” says Jonathan Kahan, partner at Hogan & Hartson LLP (Washington, DC). “He has so many other large, congressionally salient issues in drugs, biotech, and biologics, I don't see him being a great help to this industry.”
So far, says Kahan, Crawford has not gotten involved with devices.
Crawford may know a lot about devices from his senior positions in FDA, but it's not his area of expertise, says Kahan. “I think that most people who become commissioner don't have a background in devices per se. But from what I've seen, I believe that Crawford, more than most, hasn't gotten involved in many device issues.”
|Pamela G. Bailey and Mark Leahey see user fees as a high priority for Crawford.|
User fees may be the most pressing device-related issue that Crawford will have to face. Industry is not happy with the double-digit increases of recent years. In addition, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) needs rewriting. Crawford may have a major role to play, because he served as acting commissioner during the MDUFMA negotiations and enactment. “Of course MDUFMA is a big issue for him because of funding and money,” says Kahan. “But I don't see any major policy changes other than trying to keep user fees alive.” He predicts that Crawford will give CDRH director Daniel Schultz a free hand to run the center.
Crawford's role in MDUFMA may come in handy when the user-fee reauthorization is negotiated. “Both industry and the agency will be well served by his role in overseeing the 2002 legislation,” says Pamela G. Bailey, former president of AdvaMed.
Mark Leahey, executive director of the Medical Device Manufacturers Association, says MDUFMA must be modified to ensure the fees don't hurt smaller firms. “Now we find ourselves in a situation where the program's facing challenges related to escalating user fees, he says. “It's important to have someone at the agency who understands the concerns with the current program and the need to make slight modifications to ensure it moves forward.” Because Congress has not delivered promised appropriations increases, without reauthorization, the program is scheduled to terminate at the end of September.
Larry Pilot believes the commissioner will communicate well with industry.
The effect of Crawford's appointment may depend on whom he selects for key positions at CDRH. “It's been demonstrated that he relies on the people who are working in the trenches,” says Larry Pilot, partner at McKenna Long & Aldridge LLP (Washington, DC).
However, a permanent position for Crawford at FDA could provide more stability to the industry. “When you're serving in an acting capacity, there is a natural tendency not to be too presumptuous,” says Bailey. People tend not to “push a lot of initiatives that they might support but that their successor might not. Being named permanently to a position tends to empower a person to implement some of [his or her] own strategic plans.”
It's not yet clear whether Crawford has any such plans for the device industry. Pilot doesn't foresee any changes unless the commissioner has been secretly dissatisfied with the program or there's pressure from Congress or other external forces. “I expect that Crawford will be receptive to communications from the device industry, healthcare community, users, and developers, to get their views about what improvements can be made, because all is not well with regard to the management of the device program and hasn't been for a long time,” he says.
Copyright ©2005 Medical Device & Diagnostic Industry