FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

Posted 28 September 2015 | By Zachary Brennan 

FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments.


Initially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act, and was intended to address formal questions posed to FDA prior to the generic drug review process and to clarify questions capable of affecting a product's review.

This guidance provides additional detail and recommendations for industry on:

  • what inquiries FDA considers to be controlled correspondence for the purposes of meeting its GDUFA commitment
  • what information requestors can include in a controlled correspondence
  • what information FDA will provide in its communications to requestors that have submitted controlled correspondence

The agency's definition of "controlled correspondence" encompasses a range of issues that can impact generic manufacturers and related industry (e.g., contract research organizations conducting bioanalytical or bioequivalence (BE) clinical trials, active pharmaceutical ingredient manufacturers, and excipient manufacturers).

Minor Changes to Draft

Revisions to the draft guidance include explanatory information that will assist generic manufacturers as they submit controlled correspondence to FDA. The final guidance also added a description of how to submit information to FDA’s Inactive Ingredient Database, and a description of enhanced communication to requestors regarding the status of their controlled correspondence.


FDA notes in the final guidance three types of inquiries that fall within the definition of controlled correspondence but which the agency has and will continue to treat differently from other inquiries on generic drugs, including (1) requests for recommendations on the appropriate design of BE studies for a specific drug product; (2) requests for review of BE clinical protocols; and (3) requests for meetings to discuss generic drug development prior to Abbreviated New Drug Application (ANDA) submission.

FDA says it will exclude these inquiries from the goal dates in the GDUFA Commitment Letter. Under that letter, FDA action on controlled correspondence letters is set to steadily ramp up from:

  • FDA will respond to 70 percent of controlled correspondence in 4 months from date of submission in fiscal year (FY) 2015.
  • FDA will respond to 70 percent of controlled correspondence in 2 months from date of submission in FY 2016.
  • FDA will respond to 90 percent of controlled correspondence in 2 months from date of submission in FY 2017.

Industry Comment

In its comments on the draft guidance, industry group Generic Pharmaceutical Association (GPhA) took particular issue with these exclusions, calling them "unacceptable and inconsistent with the stated GDUFA commitments."

"The GDUFA Commitment Letter in no way contemplated excluding categories critical for information exchange from the controlled correspondence metrics," GPhA says. "In fact, it is because FDA responses to these correspondences have been historically slow, due to resource constraints, industry clearly addressed these concerns in its agreement related to controlled correspondence."

In addition, GPhA takes issue with the guidance's proposal to end communications with requestors when a subject is under consideration but deemed complex.

"This proposal contradicts the fundamental aspects of GDUFA which was designed to enhance the FDA’s scientific knowledge-base and embraced the goals of improving communications and increased transparency," GPhA says. "GPhA respectfully requests FDA to establish a procedure that will assure timely responses to controlled correspondence including those that represent complex issues."

FDA Response

Though it did not directly address GPhA and its concerns about the exclusions, FDA noted that it received multiple comments requesting that it refrain from excluding requests for product-specific guidance on demonstrating bioequivalence. But the agency says it has declined to revise the guidance in that fashion.

Among other things, FDA says that "the short timeframe contemplated for the controlled correspondence responses is inconsistent with the well-established process for issuing product-specific recommendations described in the guidance for industry on 'Bioequivalence Recommendations for Specific Products (June 2010),' as well as with the principles in the GDUFA Commitment Letter."

FDA also said it received a number of comments on its proposal to respond to requests related to issues for which it has not yet determined a policy.

"Upon review of the comments, FDA is revising its recommendations related to such inquiries... if there is a better mechanism for a requestor to obtain comment from FDA on the subject of the request than through a controlled correspondence, the agency will direct the requestor to such a mechanism, e.g., a pre-abbreviated new drug application meeting request or the Regulatory Science Initiative," FDA adds.

FDA Final Guidance

Industry Comments

Federal Register

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