The US Food and Drug Administration has issued draft guidance, Guidance for Industry: Controlled Correspondence Related to Generic Drug Development, regarding the process by which generic drug manufacturers and related industry can submit correspondence to the FDA requesting information related to generic drug development. The guidance also describes the FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA).
Under GDUFA, the aims of the generic drug user fee program included: ensuring the safety of generic drug products; enhancing access by expediting the availability of these products; and enhancing transparency by, among other things, improving the FDA’s communications and feedback with industry to expedite product access. The FDA and industry identified controlled correspondence in the GDUFA Commitment Letter as one mechanism to support these aims
Under GDUFA, the FDA has agreed to specific program enhancements and performance goals as set forth in the GDUFA Commitment Letter that accompanied the legislation. The GDUFA Commitment Letter included detail on the FDA’s commitment to respond to questions submitted as "controlled correspondence" within certain time frames. Specifically, the agency agreed to respond as follows: the FDA will respond to 70% of controlled correspondence in four months from the date of submission in fiscal year (FY) 2015; to 70% of controlled correspondence in two months from the date of submission in FY 2016; and 90% of controlled correspondence in two months from the date of submission in FY 2017. If the controlled correspondence requires input from the clinical division, one additional month will be added to these specified goals.
The GDUFA Commitment Letter did not provide a precise definition of "controlled correspondence," and the draft guidance provides a definition as
"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." The draft guidance also specifies what inquiries the FDA considers as "controlled correspondence" for the purposes of meeting the agency’s GDUFA commitment; what information requestors can include in a controlled correspondence to facilitate the FDA’s consideration of and response to a controlled correspondence; and what information the FDA will provide in its communications to requestors that have submitted controlled correspondence.
The FDA said it will consider separately three types of inquiries that would fall into the definition of controlled correspondence, but which have historically been treated differently than other inquiries on generic drug development. These queries are: recommendations on the appropriate design of bioequivalence (BE) studies for a specific drug product (BE guidance requests); (2) requests for review of BE clinical protocols (clinical protocol requests); and requests for meetings to discuss generic drug development prior to submissions of abbreviated new drug applications (ANDA) (i.e., pre-ANDA meeting requests). In the draft guidance, the FDA said it will continue to respond to these inquiries consistent with its current practices, and to exclude these inquiries from the goal dates in the GDUFA Commitment Letter.