The FDAs fatal flaw: Unpredictability
Acknowledging the need for greater transparency and coordination with manufacturers, the FDA stands by its stringent and notoriously slower 510(k) medical device approval process relative to other countries. Yet device manufacturers complain that the agency’s unpredictable procedures, not its speed, are the key reason for industry’s growing introduction of products outside the U.S. market.

As the FDA gears up to make major changes to the approval process for medical devices in September, including a 25-step improvement plan, Northwestern University in Chicago released a study of 356 representatives of medical device manufacturers with experience in the FDA 510(k) approval process. On Tuesday, the National Press Club hosted a forum with the study’s lead investigators and a panel that included current and former executives from the FDA and medical industry, as well as consultants.

At a time when the medical manufacturing industry has expressed growing frustration over a U.S. device approval process that takes substantially longer than other countries, the forum focused on the survey’s finding that FDA’s unpredictable procedures are at the root of vendors’ dissatisfaction.

EU vs. FDA

Only 4 percent of survey respondents, 82 percent of whom had at least five years of experience in 510(k) submissions, reported approaching the FDA for device approval before other nations’ regulatory bodies. Meanwhile, 80 percent of responding industry members said they first sought approval through the European Union’s (EU) CE mark.

These findings reflected the opinion of 64 percent of respondents who said the EU offers the most predictable approval process, compared with just 8 percent who made the same claim about the FDA’s pathway.

Jeffrey E. Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, defended the FDA’s more comprehensive assessment of new products. A major difference between the two systems, Shuren noted, is that “the EU does not require that manufacturers demonstrate efficacy or value for their products.” Instead, the CE mark requires that devices meet standards of safety and performance.

“That is a good thing in for the U.S. It shows that patients are getting value and that our health system is paying for value,” Shuren insisted.

Both the U.S. and Japan average 30 or more months to approve new devices, compared with 10 to 19 months in the EU and Canada and between six and nine months in Australia.

“The real issue, in my mind, is by tightening regulations…are we providing greater protection to public health?” asked Peter B. Hutt, LLM, senior counsel for Covington and Burling and a consultant for manufacturers seeking FDA clearance. “I know of no data in the last 10 years which show that medical devices have caused public health crises, and no study showing that devices have been unsafe,” Hutt added.

“What is the justification, then, for putting up these new requirements that unquestionably hinder innovation—that double the time to market?” Hutt questioned.

Regulatory burdens and red tape

The survey results seemed to agree with Hutt, in part. Seventy-nine percent of industry respondents indicated that regulations were one of the top three most important considerations in deciding whether to invest in a new product.

Moreover, 68 percent of respondents said that the regulatory process was “critically important” in their decision for which market to enter first. Three-quarters of respondents replied both that FDA requirements are somewhat or very unclear and that the FDA ultimately followed different procedures than the ones it offered to companies to guide them through the approval process.

Four out of 10 respondents likewise called the FDA’s request for additional information or materials “scientifically unjustified,” with approximately the same number of those surveyed saying that what the FDA requested was already in their application.

Shuren agreed that the agency could do more to clarify its processes. “We’re moving for a culture change, to try to be much more open in our decision making to outside experts and the patient community to find out their tolerance for risk.”

At the same time, Shuren and the survey found fault with industry’s role in the application process. Thirty-nine percent of industry representatives admitted that they could have submitted a better application to the FDA, while one-quarter of companies reportedly did not follow the initial advice offered by the FDA. This, Shuren pointed out, slows the approval process for all devices, especially as demand on the organization and pressure on its reviewers heighten.

Shuren acknowledged that these factors have contributed to an “unacceptably high” turnover rate among FDA staff.

Unpredictability may be unavoidable, at least to an extent. Susan Alpert, MD, PhD, who became an industry executive and consultant after spending a number of years in the FDA Office of Device Evaluation, argued that FDA procedures must change.
Alpert agreed with another industry panel member, Philip J. Phillips, MBA, of Phillips Consulting Group, however, that the FDA has not provided clear guidance on which technologies merit additional clinical data and which can be judged by the precedents of other device applications.

Industry and FDA camps failed to erase the tension between maintaining investment and innovation and protecting public health. Shuren deflected arguments that the agency asks for more from manufacturers on the assumption that more science is better science, but he admittedly could not set forth clear standards that would pave a pathway to approval for vendors.

“The challenge with clinical research is it is both costly and time consuming,” Alpert pointed out. Shuren maintained, however, that although harmonization of standards and procedures with other nations’ regulatory bodies are important, the agency would not relinquish its tighter clinical requirements for medical approval.