Regulated industry is adept at working collaboratively with FDA to bring novel therapies and medical devices to market. At times, however, there are scientific and other disagreements both within the agency itself and between the agency and sponsors. When a disagreement pertains to a question of statutory interpretation or other “legal” question, it has been common to see sponsors pursue their rights and even litigate their position. However, we are seeing an increasing number of sponsors consider their full range of options when confronted with an adverse scientific determination, such as a disagreement about emerging data regarding safety and efficacy. These assessments are happening, for example, with respect to clinical holds, refusal to file (RTF) decisions, complete response letters (CRLs), and efforts to seek voluntary withdrawal postmarketing.
This pushback often starts and stays within FDA’s administrative appeal pathways, where the appellate options are diverse. Many options, including requests for reconsideration, Type A meetings, formal dispute resolution requests, or requests for supervisory review under 21 C.F.R. § 10.75, are generally kept confidential. These options are often important first steps for life sciences companies seeking review of actions that have important implications for the development of novel therapies, such as an RTF rejecting a product application outright or a CRL setting out the agency’s views of deficiencies after it reviews an application. However, when the issue under contention pertains to the ultimate approval or withdraw of a product, an appeal can be very public, such as advisory committee meetings or other public hearings addressing whether therapies or indications should be withdrawn in light of emerging efficacy or safety considerations.
In addition, administrative disputes that are not resolved at the agency seem increasingly to be leading to litigation — or the serious consideration of litigation options. Sponsors may elect to craft a litigation complaint and give the agency an opportunity to view the draft and to correct the issues identified to obviate the need for litigation. In some recent examples, sponsors have been successful in seeking judicial review of adverse agency determinations. For example, many sponsors have challenged the marketing denial orders (MDOs) that FDA began issuing to manufacturers of electronic nicotine delivery systems (ENDS) in summer 2021. Since then, multiple manufacturers have been able to convince FDA to administratively stay or rescind their MDOs. Other manufacturers have been able to obtain judicial stays or even an outright reversal of their MDOs. In all of these cases, the product remains on the market as the challenges progress and/or FDA conducts additional review.
When seen through to completion, litigation can help to clarify the law that FDA must apply. For example, several cases in the past few years have had a dramatic impact on how FDA implements regulatory exclusivities for innovative drug products, to the point where FDA has repeatedly turned to Congress to “fix” the relevant statutory provisions.