On December 3, 2018, the Federal Trade Commission (“FTC”) submitted a comment on the Food and Drug Administration’s (“FDA’s”) revised draft guidance regarding the process for reviewing 505(q) citizen petitions (“Revised Draft Guidance”). 505(q) citizen petitions are petitions that have the potential to delay the approval of pending generic drug or biosimilar marketing applications. The Revised Draft Guidance aims to better protect FDA’s citizen petition process from abuse by pharmaceutical companies that seek to delay generic competition. FDA issued the guidance to help spur competition in the pharmaceutical industry, as part of the Trump Administration’s war on drug pricing.
Among other things, the Revised Draft Guidance sets forth the factors that FDA will consider to determine whether the “primary purpose” of a petition is to delay generic entry, such that FDA can summarily deny the petition. The Revised Draft Guidance also provides that if FDA determines that a petition was submitted with the “primary purpose” of delaying generic entry, FDA’s determination may be memorialized in the agency’s citizen petition response and FDA will refer the matter to the FTC.
In its comment on FDA’s Revised Draft Guidance, the FTC signaled that the agencies are fully aligned toward the goals of increasing competition in the pharmaceutical space, decreasing drug prices, and increasing patient access to necessary therapies. The FTC is an independent law enforcement agency whose mission is to protect consumers by enforcing, among other things, competition laws. As part of its responsibilities, the FTC enforces competition laws in the pharmaceutical industry.
In its comment, the FTC voiced support for FDA’s endeavor to protect the citizen petition process from abuse, citing its “longstanding interest in [preventing] sham petitioning and other abuses of government processes that may inhibit competition,” as well as its interest in ensuring that consumers have access to generic drugs and biosimilars. The FTC also declared its readiness to collaborate with the FDA on abuse of the citizen petition process, as well as other potentially anticompetitive issues, and cited the two agencies’ history of working together.
Given this Administration’s focus on increasing competition in the pharmaceutical industry as part of its war on drug pricing and the promised collaboration between the FTC and FDA regarding alleged anticompetitive behaviors in the pharmaceutical industry, pharmaceutical companies should be on alert that the FTC may be on the verge of taking more enforcement actions.
