FDA Longer Drug Exams Hinder Innovation, Study Finds
The Food and Drug Administration’s longer evaluations of new drugs and medical devices hinders innovation and undermines U.S. competitiveness, an industry study found.
The regulatory environment became “troubled to the point of near crisis” in recent years as FDA product reviews focused more on risks than potential benefits and required clinical studies that take more time, the California Healthcare Institute and the Boston Consulting Group said in a report issued today.
“Reversing present regulatory trends is essential to sustaining the U.S. biomedical industry as a vibrant source of technology jobs and encouraging future advances to improve public health,” the report’s authors said.
Companies are pressing for changes as Congress prepares to overhaul a law next year governing drug and device reviews. The Republican-led House Energy and Commerce Committee said on its Web site that a hearing it’s holding today with FDA, industry and medical officials on the state of the medical-device industry is focusing on “the impact of regulations on job creation and patient access.”
The rule’s last update, in 2007, increased FDA oversight of product safety after the agency took years to determine that Whitehouse Station, New Jersey-based Merck & Co.’s painkiller Vioxx and Brentford, U.K.-based GlaxoSmithKline Plc’s diabetes pill Avandia had heart risks.
Vioxx was pulled from the U.S. market in 2004; Avandia was restricted last year.
‘Not Keeping Pace’
The FDA spent an average of 18.9 months reviewing drug applications submitted in 2008, 28 percent longer than the average for the five-year period ending in 2007, according to the report. The average length of premarket device reviews jumped 75 percent to 27 months, while the length of expedited device reviews increased 43 percent to 4.5 months.
“Today’s FDA is not keeping pace with U.S. biomedical innovation,” David Gollaher, president of the California Healthcare Institute, said in an introduction to the report. The process is “strained by unexplained regulatory delays, by a lack of clear standards for what clinical data are necessary for product approval, and by a bureaucracy whose communications are neither consistent nor predictable.”
‘Consistently Strong’
The institute is a research and advocacy group in La Jolla whose 250 members include Thousand Oaks, California-based Amgen Inc., the world’s largest biotechnology company.
In testimony prepared for the hearing, Jeffrey Shuren, director of FDA’s device center, said “some have alleged that delays in FDA approval deprive American patients of needed therapies and push jobs overseas.” He said the FDA’s “device review performance has been consistently strong.”
He added that 95 percent of the more than 4,000 device applications subject to user fees the FDA approves annually are reviewed within deadlines the agency sets with industry.
The European Union system is different and any comparisons aren’t fair, particularly because devices in the U.S. must prove safety and effectiveness, while in the EU they don’t have to prove effectiveness, he said.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net
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