FDA amends citizen petition rules to reduce delays to generics and biosimilars

Home/Policies & Legislation | Posted 25/11/2016 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has amended the requirements for filing citizen petitions and petitions for stay of action to avoid unnecessarily delaying generics or biosimilars applications.

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In the Final Rule published in a Federal Register announcement on 8 November 2016, FDA outlines how it will implement the Food, Drug and Cosmetics Act’s citizen petition rules differently than it does at the moment.

According to the Federal Register entry, in the past, FDA has received numerous petitions requesting that the agency not approve a particular generic or biosimilar application unless certain criteria are met. In many cases, these petitions have raised scientific and/or legal issues relating to the standards for approval of an application. The Federal Register entry notes that examples of petitions suggesting a particular method for demonstrating bioequivalence or petitions claiming that a proposed generic does not contain the same active ingredient as the reference drug.

One example of such a petition was that of Teva Pharmaceutical Industries (Teva), who petitioned FDA not to approve generics of its multiple sclerosis drug glatiramer acetate (Copaxone). Teva maintained that it was not possible for a generic drug applicant to show that its product had the ‘same active ingredient’ as the originator drug [1].

However, FDA states that ‘when petitions are submitted late in the review process for challenged applications and do not raise valid scientific and/or legal issues, they may have the effect of improperly delaying the approval of an application’. By implementing the changes in the Final Rule, FDA intends to ensure that petitions are not ‘used to improperly delay’ the approval of generics or biosimilars.

The agency outlines how all citizen petitions or stays of action should include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known. Additionally, the document clarifies that the agency will consider the verification deficient unless every word in the petitioner’s or commenter’s verification matches every word of the verification evidence provided.

According to the Federal Register entry, FDA only received comments from Pharmaceutical Research and Manufacturers of America (PhRMA) on its proposed rule. In its comments, PhRMA requested that FDA included a mechanism for notifying petitioners about denied petitions and clarification on approval delays. FDA, however, rejected almost all of the comments from PhRMA and issued its Final Rule with few changes.

The Final Rule will become effective on 9 January 2017.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA rejects second citizen petition for Teva’s glatiramer acetate drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 25]. Available from: www.gabionline.net/Pharma-News/FDA-rejects-second-citizen-petition-for-Teva-s-glatiramer-acetate-drug

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Source: Federal Register

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