FDA trashes European regulatory process

The FDA is defending its approval process for medical devices in a new internal report that trashes some of the looser regulatory practices used by its European counterparts.

For years, critics have said the FDA's medical device approval process takes too long, particularly when compared with the one in Europe. In the U.S., companies argue they lose valuable time and money as they seek to improve the lives of patients they serve. That regulatory reality, the industry argues, forces companies to export jobs and seek approval outside the U.S. first. But the new report, which the Star Tribune recently obtained and highlighted, represents the FDA's counter-lobbying effort against its critics. It even has a pretty biting name: "Unsafe and ineffective devices approved in the E.U. that were not approved in the U.S."

According to the story, the agency's report discusses 12 classes of devices approved for sale in the EU but not the U.S. that are either "malfunctioning or needlessly invasive." FDA officials are critical of a number of EU standards, noting that European regulators seek less evidence and allow "private, for profit companies" to sign off on product approvals in member countries. What's more, those regulators don't disclose what evidence is used to back a product's approval. They also don't disclose if a device causes side effects or is recalled. Even if the EU system is quicker, it is far from better, the report argues.

The timing of the FDA report's release is interesting, coming, as the article notes, as Congress debates approving the $595 million user fee renewal agreement signed between the FDA and the device industry earlier this year. Industry lobbyists also continue to push for a more streamlined process to quicken the FDA approval time for certain high-risk devices, according to the story. And those critics often look to the European model, arguing that the system there works more efficiently and predictably, thus attracting more device companies to seek approval in the EU first. (This comes even as the European regulatory system has come under fire for allowing the approval of substandard breast implants, among other issues.)

One main point of conflict between the EU and U.S. regulatory systems is they look for different things, the story explains. In the U.S., for example, the FDA seeks data to prove that high-risk medical devices generate "clinically significant" results. The EU does not. And critics of the U.S. regulatory process question how to quantify "clinically significant."

Although the report does little to settle the debate over which system is better, FDA officials seem happy to have given their side as the user fee renewal debate commences. They hope that it will stem efforts to gut the regulatory process currently in place. "We were anticipating questions about the type of data we ask for," William Maisel, the FDA's deputy director for science, told the Star Tribune about the report. "This is the evidence."

- read the story