Lobbyists focus on Sen. Kennedy in fight to get FDA reform through

Legislators face November election deadline

The clock is ticking for legislation pending in Washington, DC,to reform the Food and Drug Administration. Unless the House andSenate pass some kind of compromise bill by August, election-yearpolitics will take center stage and legislators will have to startfrom scratch when Congress reconvenes after Election Day in November.

Given that looming deadline, lobbyists for the medical deviceindustry are mounting a last-ditch effort to get two bills pendingin the House and Senate through, and the compromise process complete.Among those efforts is one directed at Sen. Edward Kennedy (D-MA),who some in the industry believe is the biggest obstacle in theeffort to reform the FDA.

Earlier this year, Kennedy fought unsuccessfully against S.1477, the reform bill sponsored by Sen. Nancy Kassebaum (R-KS),during its mark-up by the Committee on Labor and Human Resources.Kennedy called the bill a threat to public health.

Third-party review of medical devices is the cornerstone ofFDA reform in both Kassebaum's bill and the other bill pendingin the House. The major difference is a matter of degree. TheHouse bill, H.R. 3201, introduced by Joe Barton (R-TX), wouldgrant accredited third parties the authority to clear for marketlow-risk devices, specifically those in Classes I and II. Virtuallyall medical imaging equipment falls into either of these two classes.Kassebaum's bill would allow third-party review, but the FDA wouldstill make clearance decisions.

If no snags are encountered, both bills could pass their respectivehalves of Congress this month, setting the stage for a conferencebetween House and Senate negotiators to work out a compromise.If the resulting compromise gets the approval of both congressionalwings, the legislation would go to President Clinton, who hasindicated that he favors moderate reform of the agency.

Kennedy could be a roadblock to these plans. The device industryexpects that the senator will try to sway opinion against thebill when it comes to the Senate floor for a vote in the weeksahead, possibly even trying to talk it to death with a filibuster.And even if the bill passes the Senate, Kennedy could still havean effect on the ultimate character of FDA reform. If Kennedywere to stop fighting the reform effort, the chance that reformlegislation will get through this year would improve.

Bringing Kennedy around is the mission accepted by MassMEDIC(Massachusetts Medical Device Council), a grassroots organizationmade up of Massachusetts-based medical device companies.

"We're not necessarily trying to get him out of the way,but to at least soften his rather hard position," said DavidEllenbogen, chairman and CEO of bone densitometry manufacturerHologic of Waltham, MA.

MassMEDIC has formed an FDA working group that is collaboratingwith Kennedy staff and FDA representatives to work out disagreements.

"There are certain planks in the Senate bill that concernthe senator and we're trying to work with his staff to try tounderstand those concerns and to help work out ways that he canfeel comfortable with them," said David Fleming, MassMEDICchairman and president of Massachusetts medical device maker Genzymeof Cambridge. "Our key focus is how do we get to the endresult of having responsible FDA reforms. We're trying to be apositive force to get this out of the Senate, get it into conference(between House and Senate negotiators), get it to the White House,and get it signed."

Fleming, Ellenbogen, and their fledgling MassMEDIC associationare believed by some to have the best chance of any group to influenceKennedy. Their strategy is to focus their senator on homegrownissues, reminding him that he has an obligation to the citizensof Massachusetts and that his opposition to the pending legislationcould impact the economic well-being of the state and the jobsof his constituents.

"The medical device sector in Massachusetts provides 15,000manufacturing jobs and generates over $3.5 billion in annual sales,"Fleming said. "I think Senator Kennedy has to take that intoconsideration when he thinks about the effects of having FDA reformor not having it."