Regulatory Policy Is Low-Profile Issue in ’96

It’s not easy getting a politician’s ear in an election year. Just ask anybody in Orange County’s drug and medical device industry.

The industry’s abiding concern, of course, is the future of federal regulation. But the issue has slipped off the front burner of national politics this year.

“It’s not even on the stove,” laments Bob Bard, vice president of regulatory and legal affairs, at I-Flow Corp., the Irvine maker of infusion pumps.

Bard, a member of the 250-member Orange County Regulatory Affairs Discussion Group, representing 115 local companies, is having trouble lining up political speakers for the group’s annual conference May 1 at the Irvine Marriott. While last year’s meeting drew 250 people, planners expect as many as 150 more this year, with like-minded groups from elsewhere in California, Oregon and Washington expected to participate. So far, Vice President Al Gore hasn’t committed, Bard says. And Rep. Christopher Cox (R-Newport Beach) wasn’t available. His staff said he has to be in Washington that day to vote on legislation.

Among other things, the industry wants legislation passed that would limit the time the Food and Drug Administration has to approve, or disapprove, new product proposals.

Under pressure from the Republican-dominated Congress, the agency sped up approval times last year. Bard noted, for instance, that it now takes a month or two for the agency to approve a simple infusion pump, compared with more than a year two years ago.

However, with upcoming elections likely to change the country’s political complexion, the industry fears the agency will slack off again.

*

Barbara Marsh covers health care for The Times. She can be reached at (714) 966-7762 and at barbara.marsh@latimes.com.