FDA Takes Steps Against Citizen Petitions Used to Delay Generic or Biosimilar Competition

The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

Citizen petitions allow any interested party to ask the FDA Commissioner to amend agency regulations or to take (or refrain from taking) an administrative action. The FDA is required to respond to such petitions within 150 days of filing.

While 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 request for action unless the written request convinces the FDA that a delay is necessary to protect the public health, citizen petitions have been the subject of controversy. 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.

Learn more about citizen petitions.

In a statement announcing the new guidance, FDA Commissioner Scott Gottlieb, MD, noted that, “While the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with [citizen petitions] can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making.”

The new guidance, Gottlieb explained, will help to improve the agency’s review process efficiency as a way to discourage companies from improperly filing petitions.

A key feature of the guidance is FDA’s stated intention to refer to the Federal Trade Commission (FTC) any petitions that have been submitted with an apparent intention to thwart competition. That announcement comes after the FDA signaled its intention to work more closely with the FTC earlier this year.

The guidance indicates that 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, among others:

• Submission of a petition on which the FDA has already provided an opportunity for public comment
• 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

In addition to sending such petitions to the FTC for further scrutiny, says the FDA, the agency will highlight such petitions in its annual report to Congress.