Background
As a means of presenting scientific challenges to potential new market entries, Citizen Petitions have become a significant factor in the approval of generic drugs. In January, the FDA issued a guidance document providing their thoughts on the law. While there is nothing shocking nor unexpected, there are some helpful interpretations. Like all FDA guidance documents, it represents their “current thinking” and is in no way binding.

What We Think
At The Weinberg Group, we believe the fact that FDA is addressing this issue shows the Agency has increased concerns that the petition process is being used by some in an unintended manner. We believe FDA thinks the petition process is being used to bring unnecessary delays to competitive products, rather than presenting sound evidence. Our experience suggests that the most successful petitions will be those based on sound scientific evidence correlating the new product to increased risks to human health. This can be done in many ways, but we believe companies that continue to adopt a Citizen Petition life cycle management strategy are at risk of losing credibility in the market and with FDA. Our advice is to understand the unique scientific attributes of your products, define the human value and defend your products based upon those variables. This is best done in the development process and as part of a more comprehensive product life cycle management scheme.

Highlighted Aspects

The Law: Section 505(q)
505(q) was enacted on September 27, 2007, as part of the FDAAA Act. It describes the specific terms under which a Citizen Petition could delay the approval process of an ANDA or 505(b)(2) NDA. The most significant aspect of the law is that that it essentially prevents a Citizen Petition from delaying the approval process unless, “the Secretary determines, upon reviewing the petition, that a delay is necessary to protect the public health.”

The Guidance Clarifies Five Aspects of the Law

• How to determine if 505(q) applies to a petition
• The petition must be submitted on or after September 27, 2007.
• The petition must be in writing and must contain all relevant information (no cross-references).
• At least one ANDA or 505(b)(2) related to the subject matter of the Petition must be pending at the time the Petition is submitted.
• Acting on the petition would cause a delay in approval.
• Petitions originated by the sponsor of the ANDA or 505(b)(2) NDA are excluded.
• Petitions related solely to approval timing in relation to the 180-day exclusivity provision are excluded.

• How FDA determines if a petition would delay approval of an application
  • The Agency must determine that the application would “. . . be ready for approval but for issues raised by the petition.” AND
  • The Agency must decide that public health could be negatively affected if the drug were approved before a full review of the Petition is completed.

• How Failure to Abide by Certification Requirements Impacts Petition Review: 505(q)(1)(H) FDA is compelled to respond within 180 days of the submission of the Petition. If the Petition is incomplete or does not use the proper certification text, the Petition must be resubmitted and the 180 day clock starts again.

• Impact of Verification Requirements: 505(q)(1)(I)
  FDA will not consider any supplemental information or comments unless this information contains the verification statement contained within the law.  If supplemental information has been submitted without this statement, it should be resubmitted with it.

• How the law applies to applications for which the agency has not made a final decision on approvability


If the 180-response deadline occurs before the Agency has determined whether an application is approvable, the Agency need not make an approvability decision until the entire application has been reviewed.  The Agency concluded it would not be appropriate to force a premature decision on the Petition which could potentially deny the applicant of procedural rights.