On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This is the latest public step by the agency to highlight its continued close scrutiny of potential abuses of the citizen petition process to block or slow the entry of would-be competitors into pharmaceutical markets. Although substantively the FTC’s comment does not provide new guidance as to what it will consider to be anticompetitive citizen petitioning activity, it is a strong signal of the FTC’s support for the FDA’s revised guidance, as well as the agency’s intent to remain active in challenging FDA petitioning activity that it deems to be anticompetitive.
Released on October 2, 2018, FDA’s revised draft guidance was announced nearly a year after FDA Commissioner Scott Gottlieb first warned drug companies to “end the shenanigans.” The stated intent of the FDA revised draft guidance is to put in place a more efficient approach to citizen petitions and reduce the regulatory burden on FDA by discouraging companies from improperly using the citizen petition process. The draft guidance reiterates FDA’s authority to deny petitions submitted primarily to delay approval of another drug and outlines FDA’s intent to highlight such petitions in its annual report to Congress.
Notably, the FTC comment highlights the factors identified in the revised draft guidance that will be considered in determining whether a citizen petition was submitted primarily to delay approval of a competing drug. Those factors are as follows:
- the petition was submitted unreasonably long after petitioner learned or knew about the relevant information;
- the petitioner submitted multiple and/or serial petitions;
- the petition was submitted close in time to expiration of known patent or exclusivity;
- the petition’s scientific positions were unsupported by data or information;
- the petition was the same or substantially similar to a prior petition to which the FDA had already substantively responded;
- the petitioner had not commented during other opportunities for input;
- the petition requested a standard more onerous or rigorous than the standard applicable to the petitioner’s drug product; and
- other relevant considerations, including the petitioner’s history with the FDA.
The FTC also highlighted that it is particularly concerned about the “abuse of [the] citizen petition process to delay beneficial, procompetitive generic or biosimilar entry,” noting several public meetings over the past year and half in which the FDA and FTC have collaborated where this issue was raised.