Should It Be a (j) or (b)(2) Application? FDA Gives Advice

In another flurry of guidance issuances, FDA has provided (what I thought would be) a really good read.  I was hoping that the long-awaited Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (here) would have some new insight into choosing which regulatory submission path to follow; however, while being a good primer for those who may not be familiar with the intricacies of Hatch-Waxman, for us generic nerds, it is simply a restatement of facts and previous policies.  Don’t get me wrong – it is well worth studying for sponsors not familiar with the specific issues, so please use this tool in making decisions on submission types.

FDA notes that “[T]his guidance highlights criteria for submitting applications under the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under section 505(j) or under section 505(b)(2) of the FD&C Act, and provides direction to potential applicants on requesting assistance from FDA in making this determination.”

It describes the differences in the types of ANDAs and NDAs and their separate regulatory considerations.  It discusses petitions, bundling issues, and defines duplicates of a drug.   It gives examples of changes that are permissible in an ANDA that may differ in certain aspects of the reference listed drug (RLD) (i.e. specific labeling differences, container closures systems, gives advice on drug device combinations, active ingredient sameness and differences in inactive ingredients that may or may not be permissible).

It further discusses the scientific considerations that are critical when making decisions about the appropriate regulatory submission type and discusses the concept of limited confirmatory data, intentional differences between the proposed drug and the RLD as well as other differences.

Be sure to know what regulatory path to select or it could waste valuable time and resources, and remember because the submission of an ANDA or 505(b)(2) application is confidential, until the Agency approves the application you might get caught in a situation where your regulatory type, either pre- or post-submission, is no longer appropriate.  These issues are spelled out in the guidance. Just be prepared before making that regulatory submission decision. Read the guidance and beware!