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The process of appealing a medical device approval or marketing clearance decision by the Food and Drug Administration is slow and inefficient, and needs to be reformed to make it a more useful tool for companies unhappy with an agency decision, an attorney said during a June 21 webinar.
Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara in Washington, said there are many formal procedure options available if a company wants to appeal an FDA clearance or approval decision, but they are usually not commercially viable and hardly ever used because they take too much time and cost too much money.
Most medical devices require 510(k) premarket clearance or a premarket approval (PMA) application prior to marketing. However, Shapiro noted that obtaining clearance or approval is more challenging today because of more complex technology and more demanding regulatory requirements. As such, he said, FDA's role as gatekeeper is much more pronounced and can often put it in conflict with industry. Often, those conflicts can center around FDA requiring additional data from a 510(k) petition, or rejecting a device as a suitable predicate—which is required in order for FDA to clear a 510(k) as substantially equivalent. For a PMA application, FDA could refuse to file, or possibly send the company a “not approvable” letter.
Shapiro said companies should make an effort to avoid using the appeals process, mainly because of the time and money required for an uncertain outcome. If an appeal cannot be avoided, Shapiro suggested that companies need to think of the specific issues at hand, and keep the appeal simple.
“Focus on the defined errors that justify reversal,” Shapiro said. Often, appeals are denied based on misapprehensions, he said. The more complex an appeal is, the more likely high-ranking FDA officials will “defer back to the review team” which denied the product in the first place.
While there are different methods of appealing a decision—such as the Medical Devices Dispute Resolution Panel, a petition for administrative reconsideration, filing a citizen's petition, or a public hearing before an advisory committee—Shapiro said supervisory appeals are almost always the only realistic choice.
Supervisory appeals are private and informal, and generally the quickest and least expensive appeal option. Shapiro said FDA has a three month “target” to resolve supervisory appeals, but there are no statutory time requirements and upper management is often busy, so appeals can languish. Another potential issue is that upper management is presumptively reluctant to overrule a primary review team.
All other potential appeals are much more formal and often public, but FDA will not necessarily move any quicker. For example, while there is no deadline for a company to file a citizen petition, the agency by law has 180 days to respond. Yet FDA frequently misses the deadline by months or even years, and there is no penalty for the agency missing deadlines, Shapiro said.
A petition for administrative reconsideration is not much better. Shapiro said it must filed within 30 days of the date of the FDA decision, but waiting for FDA to respond is usually not worth it, he said.
Another potential problem is if FDA denied a 510(k) application. A company could dispute a request for additional information or a determination of not substantially equivalent, but unlike with a premarket approval application, there is no statutory right to appeal a 510(k), Shapiro said.
Shapiro suggested that FDA could establish an Office of Appeals for Premarket Submissions. The office would be located within the director's office of the Center for Devices and Radiological Health, and report directly to the CDRH ombudsman.
The ombudsman is still the most helpful person within FDA when dealing with procedural issues like a delayed agency response to an appeal, Shapiro said. However, the ombudsman's office will not help with the actual substance of an appeal.
Shapiro said this potential appeals office would have a dedicated staff with multidisciplinary scientific/medical expertise, and varied premarket review experience. It would standardize the appeals process by operating under a written procedure with established milestones and timelines. It would also create a single office to hold accountable with metrics for timely and fair appeals, Shapiro said.
By Nathaniel Weixel
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