Health Science Funding Case – A Lesson in How Not to Address Marketing Uncertainty Surrounding Medical Foods

By Riëtte van Laack

As we reported previously, in 2013, Health Science Funding, LLC (HSF) filed what might be the first medical food lawsuit against FDA.  Plaintiff markets a medical food for women with lupus, Prastera® DHEA.  Medical foods may be marketed without pre-market approval by FDA.  In fact, as HSF learned, FDA will not approve or review the label for a medical food or any other food before marketing, even if the company requests that FDA do so.

In 2013, seemingly unwilling to live with the uncertainty as to whether FDA would disagree with HSF’s determination that Prastera qualifies as medical food under the Orphan Drug Act Amendments of 1988, 21 U.S.C. §360ee(b)(3), HSF filed a complaint asking that the Court declare that Prastera is a medical food and enjoin FDA from taking action against Prastera in the future.  The Court did not seize the “opportunity to create a legacy” provided by HSF’s lawsuit and, in November 2013, after various communications with the parties dismissed the case without prejudice.

HSF apparently concluded that the Court closed the case because FDA had agreed to let the company market its medical food and to refrain from any enforcement action in exchange for HSF’s stay of its request for Declaratory Judgment.  FDA inspected the firm 1.5 years later, and, apparently, threatened seizure.  HSF believed that was inconsistent with this “agreement.” 

After several failed attempts to get FDA to commit to refrain from taking enforcement action, HSF again went to Court.  HSF filed a new complaint, again requesting that the Court issue a declaratory judgment and enjoin FDA from taking enforcement action. 

The Court granted FDA’s motion to dismiss. This time, the Court issued an opinion which clarifies that the case was premature.  As FDA had not taken any final agency action, HSF’s claims were not ripe.  The court found that FDA had only informally advised HSF that Prastera does not appear to meet the requirements for a medical food.  FDA had “not enforced, nor made any attempt to enforce [the Federal Food, Drug, and Cosmetic Act] against Plaintiff or its product[].”  Thus, there was no agency action, let alone final agency action, for the Court to review.  For similar reasons, the Court determined that HSF had no standing to bring a claim for injunctive relief. 

Because the Court concluded that it has no jurisdiction, it did not need to address the other issues FDA raised in its motion to dismiss, such as what constitutes a medical food and whether FDA’s interpretation of the medical food definition is valid.  Like any other company, HSF has to live with the uncertainty as to whether FDA will determine that its product does qualify as a medical food and, if not, whether and when the Agency will decide to take an enforcement action against the product. 

FDA is no friend to the medical food category, and this case further illustrates the marketing uncertainty surrounding virtually all medical foods.  FDA’s issuance of recent final guidance, that is in conflict with the broad statutory definition of medical foods has negatively impacted the future of this market category.  Nevertheless, regulatory risk for most medical foods, while unavoidable, can be effectively managed.  However, asking FDA for approval or suing the Agency is not part of such strategy.