Shuren's Remarks Highlight Flashpoints in Broader Debate About Regulatory Approaches of FDA, EU

When CDRH chief Jeffrey Shuren said during a January conference call with reporters that European device regulations treat the public “like guinea pigs,” he seemed to ignite a bit of an international incident.

Paola Testori Coggi, director general of the European Commission’s health and consumers department, responded to the remarks with a strongly worded letter to FDA commissioner Margaret Hamburg on Feb. 18, defending the EU’s regulatory practices. 

“I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way,” Coggi wrote, according to Reuters. Regarding Shuren’s apparent implication that the European regulatory process has put the public at risk, Coggi wrote that she “would appreciate if [FDA] could share this information with European regulators.”

A few months before Shuren made his remarks, a study by ExploraMed CEO and Stanford University professor Josh Makower concluded that the European model for device approval was faster than FDA’s and just as safe. Critics of the FDA’s comparatively lengthy approval process tout the results of the study in an effort to make a case for less restrictive regulation.

“I sense frustration at FDA with the comparison to Europe, and [Shuren] may have just had a bad moment,” says Jeffrey K. Shapiro, an attorney with Hymen, Phelps & McNamara who represents medical device manufacturers. “I’m sure he doesn’t really think that Europe is unregulated and everyone’s a guinea pig. I think he was using hyperbole to make a point.”

Nevertheless, Shapiro says he understands why people in the industry are so interested in making that comparison.

“Europe is a civilized [continent] with a robust healthcare system that gets innovative devices sooner than we do, and there’s not been publicized evidence of people being used as guinea pigs, dropping dead in the street, dropping dead in hospitals, as a result of this,” he says. “The Europeans do provide probably a lower level of premarket scrutiny, but the real question is whether their scrutiny is adequate for a reasonable safety and effectiveness check. Considering that they’re an advanced civilization that is not undergoing any kind of crisis where every so often a device runs amok, I’d say maybe they’re doing some things right.”

Christoph Hiltl is an attorney based in Munich who regularly advises medical device makers. He confirms that while there have been some device failures since the system’s inception, none have grabbed headlines, for whatever reason. “So everybody is quite comfortable with the present situation, and there’s no appetite for change at the moment,” he says.

However, this does not mean that the system is perfect. “I can understand [Shuren’s] concerns,” Hiltl says. “Quick is not always safe.”

Hiltl says that the difference between the two approaches runs deep. “In Europe,” he notes, “regulation of medical devices must be stricter than with food but less strict than with medicinal products. So in the end, it boils down to the question of how much risk a society is prepared to accept. With regard to medical devices, the U.S. is probably more risk-averse than Europe.”

Hiltl says that he has mixed feelings about the European system. “It works to an extent,” he says. “No regulation is perfect. It works, but it has its tweaks.”

He cited two cases in which clients had sought European approval for devices that had been rejected by FDA. Both devices went to market quickly in Europe.

“The flip side of safety is certainly slowness, “ he says, “and on the other side, you can go quickly to the market the less regulation you have, but then safety for the user is inherently lower.”

To those who want to advance a more European-style regulatory system in the United States, Hiltl cautions that device regulation is complex and involves much more than just approving new products efficiently. For example, he says, making the American approval process easier but less stringent may have negative consequences in the product liability area down the road.

“There are many angles to that [issue] and I think you cannot simply just change one part of the equation. You have to look at every angle before you say, change this bit. Everything is interconnected, so it would be a very hairy operation to say, ‘Yeah, that goes quicker, let’s do it quicker.’”

As for where he stands, Hiltl says that he would be in the middle of the spectrum when it comes to efficiency vs. effectiveness.

“The ideal world would be a blend, some meeting somewhere in the middle,” he says, “but it is probably not possible, and would be a very lengthy operation anyway.”

For its part, Eucomed, a group that represents European device makers, firmly believes in the European system. “Globally, the EU safety requirements form the basis of the gold standard in the global regulatory model mainly because they form a robust set of safety requirements capable of dealing with diverse and novel technologies,” said John Wilkinson, chief executive of Ecuomed, said in a written statement. “In addition to the high quality safety requirements, the EU system makes the most efficient use of government resources which contributes to effective management of the public health systems and budgets.”

Representatives of FDA were not able to comment in time for this story, though FDA spokeswoman Karen Riley did tell Reuters, “All systems should continually be trying to improve” and “that is why both we and our European colleagues are actively looking at ways to help make our systems even better protectors of public health and promoters of new health care innovation.”