Important Recent FDA Actions to Support Complex Generic Drug Development

Today, October 2, 2017 the FDA took two important new steps to support the development of high quality abbreviated new drug applications (ANDAs) for complex generic drugs: Publication of the draft guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This draft guidance describes the enhanced process for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an abbreviated new drug application (ANDA) for a complex generic drug product to FDA. The draft guidance defines complex generic drug products for purposes of these meetings, defines meeting types, provides related GDUFA II performance goals, offers recommendations for meeting requests, and provides general information on FDA’s assessment of meeting requests, rescheduling or canceling meetings, meeting package content and submission, pre-meeting communications, conduct of meetings, and meeting minutes. FDA is issuing this draft guidance to assist ANDA applicants and prospective applicants in creating and submitting meeting requests, including meeting package materials, for formal meetings with FDA regarding complex generic drug products as defined in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter). The draft guidance also describes the performance goals for formal meetings between FDA and ANDA applicants of complex generic drug products. To comment on the draft guidance, please visit the public docket, FDA-2017-D-5739. Additionally, the FDA has recorded a webinar to walk applicants through this guidance. The presentation and accompanying slides are available on FDA.gov. Publication of the draft guidance for industry entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products that Refer to Listed Drugs of rDNA Origin.” The FDA is issuing this draft guidance to assist potential applicants in determining when an application for certain synthetic peptides (glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a listed drug of rDNA origin should be submitted as an abbreviated new drug application (ANDA). Given the  current state of technology for peptide synthesis and characterization, the agency believes it is now possible for an ANDA applicant to demonstrate through physiochemical characterizations and biological evaluations whether the active ingredient in a proposed generic synthetic peptide is the same as the active ingredient in the RLD that is of rDNA origin. A determination of whether an application for the synthetic peptide should be submitted as an ANDA depends largely on its impurity profile as compared to the impurity profile for the peptide of rDNA origin. Differences in impurities, particularly peptide-related impurities, may affect the safety or effectiveness of a peptide drug product. The draft guidance describes the circumstances under which submission of an ANDA for a synthetic peptide drug product that refers to a peptide drug product of rDNA origin generally would be appropriate. To comment on the draft guidance, please visit the public docket, FDA-2017-D-5670. These actions are part of FDA’s larger Drug Competition Action Plan aimed at encouraging generic drug competition as an indirect way to help reduce drug prices. ANDAs for complex generic products, like peptides, may involve more review cycles than standard products. The agency has therefore worked to develop guidances, policies, and processes that clarify when the ANDA pathway may be available for complex products. These efforts may facilitate the submission of ANDAs and the introduction of more generic medicines to the complex drug marketplace, which has generally faced limited competition. Learn more in today’s FDA Voice Blog post by FDA Commissioner Gottlieb.