FDA Releases Final Guidance to Determine if Citizen Petitions Are Abusive

September 20, 2019

The FDA this week finalized industry guidance intended to stop citizen petitions used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

The FDA this week finalized industry guidance intended to stop citizen petitions used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

“One of the anticompetitive tactics we’ve been concerned with involves companies submitting certain types of citizen petitions in order to delay FDA action on a generic or other abbreviated application,” FDA Acting Commissioner Ned Sharpless, MD, said in a statement. “While the FDA has rarely delayed specific drug approvals because of citizen petitions, there’s no doubt these shenanigans can burden the drug review process.”

The final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, describes what constitutes a 505(q) petition and some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a drug application. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may note this determination in the petition response, which is posted publicly. The agency believes this will provide an additional deterrent to pursuing these tactics.

Citizen petitions are an avenue for any interested party to ask the FDA commissioner to change agency regulations or take—or refrain from taking—an administrative action. In the case of drug makers, such requests may include asking the FDA not to approve a generic or biosimilar product unless certain conditions are met. The Food and Drug Administration Safety and Innovation Act, enacted in 2012, holds that approval of a pending drug application must not be delayed because of a citizen petition’s request for action (unless the petition convinces the FDA that a delay is needed in order to protect the public health).

However, citizen petitions have nonetheless been the subject of controversy, as they require significant time and resources for the FDA to address. Among many stakeholders, there exists a consensus that brand-name drug makers could (and sometimes do) use these petitions to forestall competition from generic or biosimilar drugs. During the FDA’s 2017 meeting on administering the Hatch-Waxman amendments, numerous stakeholders raised the question of whether citizen petitions filed by brand-name drug makers could be used to forestall competition.

The FDA may determine that a petition was submitted with the primary purpose of delaying an application’s approval based on a number of criteria, including, but not limited to:

  • Submission of multiple petitions
  • Submission of a petition close to the date on which an application could be approved
  • Requests for a product to meet more rigorous standards of testing than required for an originator product
  • Submission of a petition on which the FDA has already provided an opportunity for public comment
  • Submission of a petition with little to no data to support any claimed scientific positions
  • The history of the petitioner with the agency

The guidance reiterates that the FDA will refer any petitions that are aimed at delaying an application to the Federal Trade Commission. In addition, the FDA will include in its annual report to Congress the determinations of petitions that are judged to have been submitted with the primary purpose of stalling an approval.

If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the guidance states that the FDA would expect to respond to that petition within 150 days, aligning the FDA’s 150-day timeline to review and respond to these petitions described in section 505(q) with the timeline for review of the applications themselves.


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