FTC 'Ready' To Go After Abusive Citizen Petitions; Allergan Wants 'Substantive' FDA Responses

US FDA draft guidance on citizen petitions elicits comments of support, including call to exclude brand manufacturer petitions except in urgent situations.

The US Federal Trade Commission told FDA it is ready to help the agency halt citizen petitions that are intended to delay approval of generics or biosimilars.

In October, the agency issued revised draft guidance on citizen petitions saying that if it determines a petition has been submitted with the primary purpose of delaying an application, it would refer the matter to the FTC for possible enforcement action. (Also see "US FDA Amps Up "Name And Shame" Approach To Thwart Anti-Generic Tactics" - Pink Sheet, 2 Oct, 2018.) 

"We share the FDA's concern about abuse of its citizen petition process to delay beneficial, procompetitive generic or biosimilar entry," the FTC said in comments on the guidance. "Furthermore, we stand ready to work closely with the FDA on citizen-petition abuse and other issues that may harm competition."

The Commission announced submission of the comments in a Dec. 4 release. It said that although some citizen petitions raise genuine issues for scientific consideration, many do not, and are denied as lacking merit.

The FTC has taken one enforcement action against a company for allegedly abusing the citizen petition process. Last year, it sued Shire PLC subsidiary Shire ViroPharma Inc. for submitting more than 40 filings, including 24 citizen petitions and three lawsuits against FDA. It claimed they were meritless and intended to delay approval of generic versions of Vancocin (vancomycin). (Also see "FTC’s ‘Awesome’ Suit Against Shire Targets Citizen Petitions" - Pink Sheet, 8 Feb, 2017.)

The US District Court for the District of Delaware dismissed the complaint, saying the alleged conduct had stopped almost five years before the suit was filed and that the FTC had not shown that Shire was about to violate any law enforced by the Commission. (Also see "Shire's Citizen Petitions Too Old For FTC Action; Door Left Open For Amended Suit" - Pink Sheet, 27 Mar, 2018.) 

The FTC has appealed the decision to the US Court of Appeals for the Third Circuit.

'Non-Substantive' Denials Elicit New Petitions, Allergan Says

The new draft guidance replaces a 2014 draft guidance describing FDA's interpretation of a provision in the FDA Amendments Act of 2007, Section 505 (q), intended to address perceived citizen petition abuse. The provision requires FDA to respond to petitions within a specified time frame and permits the agency to summarily deny a petition if it determines it was submitted with the primary purpose of delaying the approval of an application and does not on its face raise valid scientific or regulatory issues.

The revised guidance specifies factors FDA will consider in determining if a petition was submitted to delay approval. One consideration is if the petitioner submitted multiple or serial petitions raising issues that could have been addressed in the original petition.

In its comments, Allergan PLC called on FDA to commit to providing substantive responses to citizen petitions.

Allergan said that to comply with the provision's deadline and to avoid premature determinations about certain issues, FDA has adopted the practice of denying certain citizen petitions on "non-substantive" grounds. "In reality, this means that FDA procedurally deems a petition to be denied without actually substantively deciding whether the petition has merit and thus should be granted," the company said.

Allergan said that the only way petitioners can receive a response after a "non-substantive" denial is to file a new petition to open a new petition docket.

"Such petitions are sometimes referred to pejoratively as 'serial petitions,' but that is unfair and reflects a misunderstanding of Section 505(q) and FDA's practice of issuing non-substantive denials," the company said. "After all, a petitioner should be entitled to receive a meaningful response to its petition at some point."

Allergan also said it disagreed with FDA's characterization of 505(q) petitions as adding to resource burdens on the generic drug review process and taking resources away from the daily work of application review. This "disregards the equally critical purposes and benefits of robust petitioning as envisioned by Congress when it instituted and then amended the citizen petition process," the company said. It asserted that FDA should avoid discouraging the submission of citizen petitions.

Allergan has filed three citizen petitions asking FDA not to approve an abbreviated new drug application for a generic version of Restasis (cyclopsorine) that relies on in vitro or other nonclinical analyses, in February 2014, December 2014, and August 2017. The agency denied all three petitions. It issued a 38-page letter in response to the first petition, a 44-page letter in response to the second, and a six-page letter in response to the third.

Brand Manufacturers Should Be Excluded From CP Process, PCMA Says

In other comments, the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, voiced support for the draft guidance, including the agency's plan to refer abusive petitions to the FTC. It proposed that the agency go further to prevent brand name manufacturers from trying to delay approval of generics.

PCMA suggested that the citizen petition process "be reformed to exclude brand drug manufacturers, except perhaps with respect to an urgent public health issue or similar urgent situation."

The association said brand drug manufacturers could use other forums to pursue intra-manufacturer disputes currently brought under the petition process, such as going through the FDA Office of the Ombudsman.

Consumer groups, including Public Citizen and Consumer Action, jointly submitted comments saying FDA should be more aggressive in using its authority to summarily deny petitions that are not clearly substantiated. They also encouraged the FTC to continue seeking ways to solve the problems that are leading to higher drug prices.

The groups cited a 2016 study published in American University Law Review, which found that FDA has denied 92% of all 505(q) petitions and 98% of late-filed petitions.

Premier Inc., which provides group purchasing and other healthcare services, recommended that FDA work with Congress and other stakeholders to create greater transparency by requiring that petitions be filed directly by the principals, such as manufacturers, "and not by law firms or consultant groups that mask the identity of the principal."

The company also said the agency should establish monetary penalties for entities that persistently file citizen petitions with the primary purpose of delaying competition.

The BlueCross BlueShield Association and the Leukemia & Lymphoma Society also submitted comments supporting the draft guidance.