FDA publishes draft guidance for industry: Competitive Generic Therapies

On February 15, 2019, the FDA published a notice of availability for a draft guidance for industry entitled “Competitive Generic Therapies.” This draft guidance:

• Describes the process that potential abbreviated new drug application (ANDA) applicants should follow to request designation of a drug as a competitive generic therapy (CGT) 
• Outlines the criteria for designating a drug as a CGT
• Provides information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs
• Explains how FDA interprets the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs

The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended the Federal Food, Drug, and Cosmetic Act to add new provisions related to CGTs. These new provisions, which are described in the draft guidance, provide incentives for effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition.  

The FDA recognizes that various factors may influence an applicant’s decision to develop a generic medicine. For instance, some drugs may not attract a high level of interest from potential applicants if there is a limited market for those products and/or if the products are more difficult to develop. Nevertheless, these drugs can play an important role in diagnosing, treating, and preventing various types of disease or conditions, and incentivizing generic competition for these products can help ensure patients have access to the medicines they need. 

To facilitate increased competition for these products, FDA may take certain actions to expedite the development and review of an ANDA for a drug that is designated as a CGT. These actions, as further described in the draft guidance, may help to clarify the regulatory expectations for a particular drug, assist applicants in developing a more complete submission, and ultimately promote a more efficient and effective ANDA review process in order to help reduce the number of review cycles necessary to obtain ANDA approval.

This draft guidance is being issued as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor. 

References:

• Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition
• Draft guidance
• Public docket - FDA-2019-D-0065