Copyright 2000 Globe Newspaper Company
The Boston
Globe
May 9, 2000, Tuesday ,THIRD EDITION
SECTION: BUSINESS; Pg. D5
LENGTH: 397 words
HEADLINE:
DEVICE MAKERS SEEKING CHANGES FDA REVIEWS OFTEN FRUSTRATE, THEY SAY
BYLINE: By Ronald Rosenberg, Globe Staff
BODY:
WALTHAM - The uneasy relationship between the
medical device industry and its regulators is improving. But both sides
acknowledged yesterday that they still have a long way to go.
"They
ought to give us kudos, but everything ends up as criticism," said Dr. Linda
Suydam, the US Food and Drug Administration's senior associate commissioner, who
outlined some of the structural changes for future agency and industry
interactions. Suydam spoke at the fourth annual conference of
the Massachusetts Medical Device Industry Council at the Westin hotel.
Also speaking was Dr. Hugh Hill, director of the coverage and analysis
group at the Health Care Financing Administration (HCFA), which determines
whether new products approved by the FDA are effective and should be covered by
Medicare.
The FDA, Suydam said, has streamlined the
approval process for medical devices by permitting outside
groups to help the agency approve the products. The FDA also has an ombudsman to
settle issues between companies and the agency.
But some Bay State
device companies insist the approval process is still marred by too much
bureaucracy and that too often the FDA's staff is not adequately equipped or
trained to handle certain issues.
"We think FDA has changed, but the
approvals could be still be done more effectively," said Thomas J. Sommer,
executive director of MassMedic, the 200-member group representing the state's
medical device industry.
Unlike the biotechnology and pharmaceutical
industries, which nearly three years ago agreed to pay higher fees to the Food
and Drug Administration to streamline the drug-approval processes, the medical
device makers balked at hefty users fees.
One result: Drug makers, once
the FDA's loudest critics, are now among its boosters, citing approvals that
have been shortened from three years to about a year.
Device companies
argue that they should not be compared with the drug makers, since their
products have short development cycles.
Once products are approved by
the FDA, the medical device companies complain, the HCFA is slow to give its
approval.
Without HCFA approval, several executives said yesterday, it
is hard to sell products that don't have insurance reimbursement.
Yesterday, Hill said the HCFA is in the process of developing new
guidelines and procedures for device reimbursement that will be announced
shortly.
LOAD-DATE: May 9, 2000
