Proposed FDA Rule Would Amend Citizen Petition Regulations

Posted 03 January 2012 | By Alexander Gaffney, RAC 

On 3 January the US Food and Drug Administration (FDA) released a new proposed amendment via the US Federal Register that would amend the regulations governing the process for citizen petitions, petitions for stay of action, and the submission of documents to the FDA.

The proposed rule would amend the way the FDA deals with section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which regulates how the FDA responds to citizens petitions and petitions for stay of action (PSA) requests.  Currently, the FDA uses these petitions to supplement and inform their thinking when it comes to the drug approval process.

Congress amended section 505(q) in 2007 under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to stop the use of such petitions to unnecessarily delay Abbreviated New Drug Approvals (ANDAs) or drugs submitted via the 505(b)(2) approval pathway.

Under FDAAA, the FDA must respond to petitions no later than 180 days after initial receipt of the petition (30 for PSA requests).  In addition, if the FDA determines that a petition's primary purpose is to delay the approval of an application by raising invalid scientific or regulatory concerns, it can be dismissed at any time.

This proposed amendment:

  • seeks to clarify how the submission date of a petition is determined;
  • makes minor updates to the specific certifying language necessary to submit a petition, and requires specific language be used in the petition;
  • would mandate that all data-even data known to be unfavorable to the petition-be present in the petition's supplements and comments;
  • mandates that the petition must include the exact date information relevant to the petition became known to the petitioner;
  • would clarify that the FDA has the authority to dismiss certain petitions and label them as "moot"; and
  • would treat PSA's like 505(q) petitions, and not allow any delays unless the commissioner believes that a delay is necessary to protect public health, a delay is statutorily mandated, or a court orders the stay of approval.

Comments on the proposed amendments are due by 2 April, 2012.

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