On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions. Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day. The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific reviews.
For years, FDA has been addressing allegations that companies have been using the citizen petition process to delay competitor approval, thereby “gaming” the system, while also balancing the value of individuals exercising their First Amendment rights through the citizen petition process. In 2007, Section 505(q) was added to the FDCA through the FDA Amendments Act (“FDAAA”). This new statutory provision provided that FDA shall not delay the approval of a pending abbreviated new drug application (“ANDA”) or 505(b)(2) application as a result of a citizen petition (pursuant to 21 CFR 10.30) or a petition for stay of action (pursuant to 21 CFR 10.35), unless the Agency determines that a delay is necessary to protect public health. Section 505(q) also requires FDA to take final agency action on a petition “not later than 150 days after the date on which the petition is submitted.” In 2014, FDA issued a guidance document describing the Agency’s interpretation of Section 505(q) and the process by which it determines whether the section applies to a particular petition.
The revised draft guidance document that was released last week includes much of the same information contained in the 2014 guidance. However, it also includes substantially more detail and clarification on how the Agency makes a determination that a petition would delay an ANDA or 505(b)(2) application. For example, the revised guidance states that one criterion in finding a delay is that the ANDA or 505(b)(2) applicant has less than 150 days left on a pending review. The draft guidance also explains that FDA will apply a “but for” test in evaluating whether a delay is caused, essentially asking, “Would the application be ready for approval but for the issues raised by the petition?”
The revised draft guidance also provides a number of factors that FDA will consider in making a determination that a petition was filed with the primary purpose of delaying approval. These include factors such as whether the petition was submitted close in time to the expiration of a patent or exclusivity period, or whether the petition raises the same or substantially similar issues as a prior petition to which FDA has already responded. FDA will also consider whether the petitioner took an unreasonable amount of time in filing the petition based on when the relevant information relied upon in the petition became known (or should have become known). A full list of the factors can be found on page 16 of the guidance.
If FDA makes the determination that a petition has been submitted with the primary purpose of delaying an application, it will then decide whether the petition can be summarily denied pursuant to Section 505(q)(1)(E). In addition, if the Agency makes such a determination, it intends to refer the matter to the Federal Trade Commission and notify Congress in its annual report. Such an FDA determination could potentially have serious consequences as it may support causes of action related to unfair competition under the Federal Trade Commission Act, Lanham Act, and various state laws, which can carry substantial penalties.