Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application.

The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often intended to delay the approval of competing drug products and do not raise valid scientific issues.

In total, since FY 2008, 182 petitions have been resolved and just 10 have been granted, FDA said in the report. Of those not granted, 141 of the petitions (about 67%) were denied and another 53 petitions (about 25%) were denied in part and granted in part.

The 17-page final guidance, which is nearly identical to the draft, describes some of the considerations FDA will use moving forward to determine whether a petition is submitted with the primary purpose of delaying the approval of an application.

For instance, under the section, “How Does FDA Determine if a Petition Would Delay Approval of an ANDA, 505(b)(2) Application, or 351(k) Application,” FDA explains issues that could implicate the public health include, for example, “(1) whether a proposed generic drug product is bioequivalent to the reference listed drug or (2) whether an indication can be safely omitted from the labeling because that indication is protected by a patent.”

To further dissuade companies from improperly using these petitions, FDA also said it intends to refer certain issues to the Federal Trade Commission.

The guidance also explains how FDA will take final action on a petition no later than 150 days after it was submitted, and that 150-day deadline will not be extended.

Other questions answered in the guidance include, “How Does FDA Determine if Section 505(q) Applies to a Particular Petition?” and “What Is the Relationship Between the Review of Petitions Under Section 505(q) and the Review of ANDAs, 505(b)(2) Applications, and 351(k) Applications for Which the Agency Has Not Yet Made a Final Decision on Approvability?” and “What Considerations May Suggest That a Petition Was Submitted for the Primary Purpose of Delaying Approval of an Application?”

The approach outlined in the guidance, which revises and supersedes a guidance from 2014, will help ensure that FDA experts do not have to consider petitions separately from application review and therefore prematurely, the guidance adds.

And it explains how FDA may issue guidance to describe the factors that will be used to determine whether a petition is submitted with the primary purpose of delaying the approval of an application.

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry