Survey Blames FDA ‘Inefficiency’ for Job Loss
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WASHINGTON — The Food and Drug Administration’s “inefficiency” in regulating drugs and devices has led to the loss of 13,000 to 18,500 jobs in California over the last five years, according to a survey of the chief executives of medical device companies based in the state.
The survey was released in Washington on Wednesday as a House committee continued work on legislation to overhaul FDA regulations.
The survey was conducted by Ernst & Young LLP and the California Health Care Institute, which represents the interests of California drug and device companies as well as public and private biomedical research groups.
“The present regulatory process forces companies to devote disproportionate amounts of time, effort and money to the regulatory process itself, channeling precious resources away from productive science and research,” the institute wrote in the introduction to its report.
Twenty-eight of the 40 drug and medical device company CEOs surveyed by the group said they conduct initial development of drugs and devices overseas. California medical device companies alone have “directly exported” between 4,840 and 6,455 jobs, according to the institute.
In a recent Gallup Poll, nearly 25% of all U.S. health companies said they moved some operations abroad because of U.S. laws.
California biotechnology companies say they are part of that trend.
“FDA inefficiencies have cost California biotech companies between 8,000 and 12,000 jobs--including direct jobs exported and opportunity costs--with an annual salary value between $465 million and $698 million,” the institute said.
FDA officials were not immediately available for comment on the California study, though the agency did release statistics Wednesday showing that it had faster drug approvals and improved device reviews in 1995.
The FDA approved 82 drugs within 16.5 months of complete applications in 1995, compared with 62 drugs in 19 months in 1994, it said. The agency said it also reviewed and approved more medical devices in a shorter period in 1995 than in 1994.
