FDA Prepares for GDUFA Commitments

FDA Prepares for GDUFA Commitments with Controlled Correspondence Guidance

By Emily Krulewitz

With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27, 2014. Though controlled correspondence has been a staple of generic drug development for many years, this guidance iterates, seemingly for the first time, the definition of controlled correspondence. Further, the guidance specifies response timelines as well as outlines topics that are not considered controlled correspondence (though they may meet the technical definition).

The definition of controlled correspondence given in the guidance is:

    A correspondence submitted to the Agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development

To put it more simply, controlled correspondence is a way for those involved in developing generic drugs to ask a specific question of FDA. Unlike many submissions to FDA, the process for submitting a controlled correspondence is literally as easy as sending an email. The email to GenericDrugs@fda.hhs.gov must be sent from a corporate (not personal) email address and should contain:

  • Basic information about the requester (e.g., name, phone number, company)
  • An email address where the controlled correspondence response should be sent
  • Relevant information about any previous controlled correspondence submissions and the related FDA responses
  • Relevant RLDs and basic information (e.g., dosage form, strength, brand name)
  • A concise statement of inquiry
  • A recommendation of the appropriate review division
  • Relevant prior research and materials

After receiving your controlled correspondence, FDA will respond in one of two ways: in the affirmative, providing you with a tracking number, or in the negative, informing the requestor that the submission is not a controlled correspondence or that FDA lacks information to make this determination. In the GDUFA Commitment Letter, FDA agreed to goal dates for the response time of controlled correspondence; currently those dates are: 70% will be responded to within 4 months for fiscal year (FY) 2015, 70% will be responded to within 2 months for FY 2016, and 90% will be responded to within 2 months for FY 2017.

In addition to outlining the simple process for controlled correspondence, the Agency outlines all the ways that the process can become decidedly less simple. For example, if a controlled correspondence is submitted while there is a pending citizen petition regarding the same topic, the goal date clock for controlled correspondence begins after the Agency issues a response to the pending citizen petition. The guidance also lays out a number of situations where the request will not be considered controlled correspondence and therefore will not be governed by the corresponding goal dates. These situations are:

  • If a would-be controlled correspondence pertains to a pending ANDA (these questions should be submitted directly to the ANDA application)
  • Request for recommendations for bioequivalence studies
  • Requests for review of bioequivalence clinical protocols
  • Requests for pre-ANDA meetings.

For the latter three situations, the guidance states that the correspondence should still be submitted to the GenericDrugs@fda.hhs.gov email address, but will not be considered controlled correspondence. By establishing these exclusions, especially those for bioequivalence recommendations, the number of controlled correspondence will be significantly reduced and FDA should be able to meet the goal dates as outlined in the GDUFA commitment letter. However, it remains to be seen if FDA can respond to such requests in a timely manner. Another interesting nuance is that foreign companies cannot submit controlled correspondence on their own but instead must go through a US agent. While acting as a US agent is a fairly simple process, and one that The Weinberg Group provides for many non-US clients, it still provides an additional hurdle for those seeking input on generic drug development.

The guidance begs the question: why does this all have to be so difficult? The answer: GDUFA. Though GDUFA will ultimately benefit sponsors by decreasing the average time to approval, GDUFA will also make certain aspects of generic drug development, like controlled correspondence, more complicated. Generic drug sponsors should pay close attention to changes being made by OGD and seek regulatory expertise to ensure that they are complying with all applicable regulations.

Emily Krulewitz is a Researcher at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.