For years, FDA has been looking to reform the Citizen Petition process to address allegations of “gaming” the system to delay competitor approval. This led to the creation of the “505(q)” petition by Congress in 2007 as part of FDAAA, the subsequent revision of the 505(q) provision under FDASIA in 2012, and the publication of a companion guidance in 2014. Along the way, FDA has referred at least one company – Shire – to the FTC for anticompetitive enforcement after years of complaints about “sham petitioning.” With a significantly revised guidance addressing 505(q) petitions, FDA is continuing to address the issue.
As part of the Commissioner’s Drug Competition Action Plan to increase prescription drug competition and facilitate access to affordable medicines, FDA published a revised 505(q) guidance earlier this week. The revised guidance includes much of the same information from the original 2014 version: the elements necessary to be considered a 505(q) petition, the requirement for a certification, the response timeline, and so on and so forth. But FDA has added a lot more detail and more explanation about its processes. For example, in the 2014 version, FDA explained that 505(q) applies only to petitions pending when it would delay at least one ANDA, 505(b)(2), or 351(k) application, but didn’t explain how it would make the determination of delay. In this version, FDA clarifies that the relevant ANDA, 505(b)(2), or 351(k) must have a user fee goal date on or before the 150-day deadline for Agency action on the petition to constitute delay in an effort to align review of the petition and review of the application. Additionally, FDA applies a “but for” test to the question of delay: Would the application be ready for approval but for the issues raised by the petition? If the answer is no, or there is no pending application or a user fee goal after 150 days, then the petition is a “normal,” non-505(q) petition – and not entitled to a response within 150 days.
After evaluating eligibility as a 505(q) petition, FDA then considers whether the petition in question implicates public health. If the application were approved before FDA reviewed the issues in the petition and determined the petitioner’s argument meritorious, FDA will look at whether the marketing of the drug product in question would negatively affect public health. Issues that could implicate the public health include bioequivalence to the reference listed drug or the safety of a labeling carve-out. These examples are the issues cited in many 505(q) petitions alleged to delay approval. It’s therefore questionable whether this element will knock many petitions out of the 505(q) category.
This guidance also further explains how FDA will determine that a petition was filed with the “primary purpose” of delaying approval of an application as described in section 505(q)(1)(E), which allows the Agency to summarily deny the petition. This here is the meat of the guidance revision. It explains that FDA expects to consider the following:
- If the date that relevant information relied upon in the petition became known or should have become known to the petitioner indicates that the petitioner has taken an unreasonable amount of time to file the petition;
- Serial submissions with issues that should have all been raised in an earlier petition;
- Submission of a petition close in time to expiration of patent or exclusivity period;
- Submission of a petition without any data or information in support of the scientific positions set forth in the petition;
- Submission of a petition raising the same or substantially similar issues as a prior petition to which FDA has already substantively responded, particularly where the subsequent submission closely follows in time the earlier response;
- Submission of a petition concerning standards for approval of a drug product for which FDA has provided an opportunity for public input (i.e., guidance) and the petitioner has not provided comment other than through the petition;
- Submission of a petition requesting that other applicants must meet standards for testing, data, or labeling for their products that are more onerous or rigorous than the standards applicable to the reference listed drug and/or petitioner’s version of the same product; and
- The history of the petitioner with the Agency.
If FDA determines that a petition has been submitted with the primary purpose of delaying an application, then FDA will decide whether the petition may be summarily denied under 505(q)(1)(E). Such an analysis is done on a case-by-case basis.
If FDA determines that a petition has been submitted with the primary purpose of delaying an application, the agency intends to refer the matter to the FTC. While FDA has rarely referred matters to the FTC, particularly with respect to Citizen Petitions, the affirmative language used in this guidance rather than the typical “may” indicates that FDA may take this step more often in the future. This raises further questions given the District Court’s recent dismissal of the Shire matter questioning FTC’s authority to bring suit for past violations of the FTC Act. FTC has appealed this decision to the Third Circuit, but for now, other parties have invoked the Shire ruling to challenge FTC’s authority in other cases.