SAN JOSE, Calif. – Europe is not experiencing greater public safety problems than the U.S. despite a widely held perception its regulatory process for approving new medical devices is faster, a new report said.
In an analysis of 5,000 European government safety notices, the Boston Consulting Group found Europe and the U.S. have a similar number of the most severe medical devices recalls, it said in a study commissioned by the Advanced Medical Technology Association (AdvaMed), an industry trade group. Europe had an average of about 21 severe recalls a year in the 2005-2009 period, about the same level as in the U.S., as measured by two separate surveys.
"We didn’t find any evidence to support the hypothesis that the European regulatory approach led to unsafe devices being available in Europe," said Simon Goodall, author of the report and a partner at Boston Consulting Group (BCS).
AdvaMed officials said they will share the report with European and U.S. regulators. The group has no specific recommendations stemming from the report about how the U.S. approvals process should be changed, said Janet Trunzo, executive vice president for technology and regulatory affairs at AdvaMed.
BCS is continuing its comparative study of recalls in Europe and the U.S., working with Ralph Hall of the University of Minnesota on a report that could be released within a month. BCS also is working on a separate report on the relative timing of medical regulatory approvals in Europe and the U.S., Goodall said.
The report comes days after the U.S. Food and Drug Administration released its 2011 plan for reforming its 510(K) process, used to regulate the majority of medical devices. Industry has complained the FDA approval processes have slowed significantly in recent years, driving many companies to seek first approvals for their products in Europe where the process is believed to be faster.
Medical device approvals can take as much as two years longer in the U.S. than in Europe, according to a survey of 200 small- and medium-sized medical companies released in November. The survey was co-authored by Josh Makower, a consulting professor at Sanford and sponsored by the Medical Device Manufacturers Association and the National Venture Capital Association.
In a separate issue, AdvaMed came out earlier this week in support of draft legislation in the U.S. that would repeal a 2.3 percent excise tax on medical devices that was part of last year's heath care reform bill.
"We believe the device tax is a serious burden for companies struggling to maintain America’s global leadership in the development of medical technology," said Steve Ubl, chief executive of AdvaMed in a written statement. "If implemented in 2013, the tax will undermine our industry’s ability to create and maintain good jobs in the U.S., and worse, will lead to higher costs for patients, undercutting one of the primary goals of health care reform," he said.
AdvaMed wants to see other elements of the reform bill left intact, including expanded coverage, reform of the payment system to encourage quality and efficiency and a new emphasis on health promotion and disease prevention, he added.