Medical device industry gropesfor consensus on reform of FDA

User-fee experience splits device groups

Efforts by the medical device industry to persuade Congress toreform the Food and Drug Administration appear to be paying off,with recent hearings held in both the House of Representativesand the Senate. More are expected as bipartisan support for FDAreform builds, including backing from Sen. Nancy Kassebaum (R-KS)and Rep. Ron Wyden (D-OR). But the medical device industry maynot be taking full advantage of the opportunity because of internecinephilosophical differences.

A number of regional and local medical device organizations havesprung up across the country, each with its own agenda. Theirlobbying efforts threaten to confuse the message that the medicaldevice industry as a whole is trying to send to Congress.

To harmonize the din, several regional, local and national groupshave banded together to form the National Medical Device Coalition,based in Washington, DC. The coalition represents more than 700medical device manufacturers, according to David Shoultz, coalitionsecretary. Shoultz is also senior manager of government relationsat Varian Associates of Palo Alto, CA.

"The issue of how to solve the problems at the FDA is verycomplex," Shoultz said.

For people on Capitol Hill who are new to this issue or donot have the depth of knowledge, it is confusing to hear lotsof different voices from industry about how to solve these problems.

But in the process of setting up the coalition, its leadershiphas ignored the two largest national associations in the deviceindustry, the Health Industry Manufacturers Association (HIMA)and the National Electrical Manufacturers Association (NEMA),and one of the best known regional associations, Medical Alleyin St. Louis Park, MN. That oversight could hurt the reform effort.

"There are maybe two handfuls of staff that drive theseissues and it's difficult for a staff that's already swamped todistill opinions from a variety of groups," said Tom Meskan,president of Medical Alley. "It is necessary that we harmonizemuch better."

The coalition's hesitancy to invite HIMA, NEMA, Medical Alleyand other groups to join originated with the formation of thecoalition late last year, when its leaders took an uncompromisingstand against user fees and shunned associations that even consideredsupporting user fees.

An independent CDRH? The user-fee issue is almost nonexistentthis year, as the medical device industry has united in its oppositionto user fees. Yet HIMA, NEMA and Medical Alley have not been invitedto join NMDC. The reason, Shoultz said, is that certain sensitiveissues continue to separate them from the coalition.

"One of the key proposals supported by the coalition isto separate out the Center for Devices and Radiological Healthand make it an independent center in the Public Health Service,"he said.

CDRH needs to be spun off to prevent the encroachment of pharmaceutical-stylerules into the regulation of devices. HIMA, NEMA and Medical Alleydo not share the coalition's commitment to creating a bureaucraticallydistinct CDRH, Shoultz said.

The divisiveness of this issue, however, might diminish as thecommunity focuses more on agreements than on disagreements. Theidea of spinning off CDRH from the FDA is one issue among many,said Brad Thompson, a partner in the law firm Baker and Daniels.

"Generally, I don't think groups would characterize thatas a terribly high priority," said Thompson, who is alsoan officer with the Indiana Medical Device Manufacturers Council,a founding member of the coalition.

Recognizing the need to speak collectively for the medical deviceindustry, several organizations that are members of the NationalMedical Device Coalition met in April in Phoenix with nonmembergroups, including HIMA and Medical Alley, in hopes of findingcommon ground for agreement. The attendees at this meeting werenot seeking to establish a competing coalition.

"It was an informal meeting to bring together everybodywho might have an interest in this issue (of FDA reform) to determinewhere the areas of agreement are," said Susan Zagame, associatevice president and counsel for technology and regulatory affairsat HIMA.

The meeting resulted in a two-page summary statement of principlesthat identifies the common priorities of the groups in attendance.Another result was the establishment of an informal network ofmedical device groups that will fax messages to each other asdevelopments regarding FDA reform unfold. The agreement reachedat the meeting and the formation of this network allow the industryto represent a broader range of companies, Thompson said.

But for the entire industry to speak with one voice may requirea single focus on which all can concentrate. That focus may comefrom Congress itself, said Robin Wiley, manager of legislativeand regulatory affairs with NEMA.

"Eventually, the device trade associations will need tocome together behind a single piece of legislation," Wileysaid. "In the meantime, it doesn't hurt to have separatevoices. The participation of organizations such as the devicecoalition lends a healthy perspective to the debate."