In an apparent effort to push back against medical device industry lobbying, the FDA crafted an internal report outlining agency successes in keeping "malfunctioning or needlessly invasive high-risk medical devices" off the U.S. market, despite their approval in the European Union.
The gesture may represent a response to FDA critics, who have long called the the agency’s medical device pathways inconsistent, unpredictable and lacking in transparency. The same critics often point to the EU’s less-stringent review system as a model for the U.S.
"If a device gets on the market somewhere else 1st [and] it’s a good device, good for them; if it’s a bad device, bad for them," FDA deputy director for science Dr. William Maisel told the Minneapolis Star Tribune, which obtained a copy of the unpublished report. "The only way to know that is to look at some of the devices and see how they played out."
The federal watchdog agency has long batted disparaging comments from device makers and industry advocates who say longer and more costly med-tech review times are sending device makers overseas.
Last summer FDA devices chief Dr. Jeffrey Shuren responded to similar remarks at the House Oversight & Government Reform Subcommittee on Health Care’s "Pathway to FDA Medical Device Approval: Is there a Better Way?"
The FDA requires that medical devices demonstrate safety as well as efficacy before winning approval to sell in the U.S. The EU system generally only requires safety studies.
Shuren balked at several GOP committee members who attempted to frame the debate on medical device regulations as a question of the European system being superior to the FDA’s, saying he was "astonished that some in medical device space are calling for us to lower our standards to those of Europe. It’s not in our best interest."
The recently uncovered FDA report supported that message by highlighting 12 classes of medical devices that never made it to the U.S. market, although not for lack of trying.
"Lowering standards of approval for devices in order to speed access can jeopardize patient health and impose high but often hidden costs," according to the report.
The European device approval system has recently come under fire from within as well. In February European Health & Consumer Policy Commissioner John Dalli called for a coordinated national effort to strengthen the EU med-tech review process.
The call came amid the EU’s ongoing high-profile controversy surrounding a recall for 1,000s of substandard breast implants provided to women in France and the U.K., an incident which challengers said was indicative of a weak foundation for medical device approval.
Late last year, news broke that France was considering a recall of 30,000 sets of breast implants supplied by Poly Implant Prosthese over concerns that they might contain a non-authorized silicone gel known for high rupture rates.
The PIP implants evaded notice despite inspections at manufacturing facilities because the company was given 10 days notice prior to the checks and workers concealed the problem silicone. There were more than 100 product alerts issued by the Medicines & Healthcare Products Agency last year, but the EU regulators can’t act unless a failure is reported.
Prior to the breast implant recall, doctors at the European Society of Cardiology meeting in Paris last August called the EU regulatory pathway too lax in review of potentially dangerous products, saying it uses the same structure to review pacemakers and electric toasters.
British medical regulator Kent Woods attempted to quell the rising clamor, warning against reactionary reforms to the European device review process and saying that the breast implant issue was rare and that no medical device review system can perfectly protect against intentional fraud.
