The Food and Drug Administration is seeking public comment on a proposal to create a new program to provide earlier access to certain high-risk medical devices.

These are devices that are intended to treat or diagnose patients with serious conditions whose medical needs are not being met by current technology. However, some stakeholders are critical of the approach, labeling it as not new and benefiting only a handful of medical device companies.

While FDA officials acknowledge that the program is "not a new pathway to market" for high-risk medical devices, they are promoting it in the proposal as a "collaborative approach to facilitate product development under the agency’s existing regulatory authorities" that "seeks to reduce the time associated with product development" as opposed to existing device programs that have "focused on reducing the time for the premarket review."

The so-called Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP program for short) leverages lessons learned from the FDA's 2011 Innovation Pathway pilot as well as the regulatory agency's experience with expedited review programs for pharmaceuticals. The pilot was a collaborative effort with industry designed to shorten the overall time and cost it takes for the development, assessment and review of medical devices.

"I see these programs rolled out by FDA every few years; indeed, this program is just the formalization of something that the agency started in 2011,” says Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green. “Unfortunately, for the vast majority of companies, these initiatives really do not prove to be useful. As I recall, when the pilot program came out in 2011, there was only one company that participated. A couple years later, when they revised the program, they got only a couple more."

Thompson has spent nearly 30 years at legal loggerheads with the FDA.  He advises medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Thompson also frequently counsels companies on premarket clearance and approval strategies. The problem, he says, is that the bar for the EAP program--a product must address “a life-threatening or irreversibly-debilitating disease or condition”--is too high and the vast majority of medical device developers will not qualify. 

In addition, Thompson notes that a product has to be a breakthrough technology that is above and beyond currently existing therapies. "Frankly, most medical devices represent incremental improvements," he argues, and although most entrepreneurs proudly tout the benefits of their new products "when the FDA looks at them it characterizes the gains as more modest."

Even if a company does qualify for the program, Thompson argues that the FDA doesn't relax any of its standards and there is no reason to believe that the regulatory agency's approval process will be any quicker. For the EAP program, the FDA will continue to apply the current approval standard of demonstrating a reasonable assurance of safety and efficacy. 

"The possible speed of the approval--and there are no guarantees of course that it will in fact turn out to be quicker--comes at the cost of FDA looking over your shoulder the entire way," he charges. “Thus, while most devices get approved based on data that the manufacturer develops with modest input from FDA, here the agency potentially micromanages the manufacturer all along the way, potentially driving up the cost of the data development."

In addition to the EAP program, the FDA has also published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met. According to the draft guidance, when making a determination whether it is appropriate to collect certain data in the postmarket setting, rather than premarket, FDA considers, among other factors, the device's potential impact on public health.

“FDA may approve a device with a greater degree of uncertainty regarding the benefits and risks of the device if this uncertainty is sufficiently balanced by other factors, including the probable benefits of the device and the extent of postmarket controls,” states the draft. “FDA may accept greater pre-approval uncertainty regarding specific benefits and risks of devices demonstrating the potential to address unmet medical needs, as long as the premarket data still support a reasonable assurance of safety and effectiveness.”

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