FDA solicits feedback on drug products approved under abbreviated new drug applications before the enactment of the Hatch-Waxman Amendments On August 12, 2021, the FDA established a public docket to solicit comments on several issues related to FDA's regulation of certain drug products approved under abbreviated new drug applications before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. Because these Pre-Hatch-Waxman ANDAs (PANDAs) were submitted under section 505(b) and approved under section 505(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act, they can serve as a reference listed drug (RLD) for future abbreviated new drug applications submitted under section 505(j) of the FD&C Act (505(j) ANDAs) and can also be a listed drug relied on by 505(b)(2) applications. Although these PANDAs are 505(b) applications, they have historically been overseen by FDA's Office of Generic Drugs. FDA is aware that there may be some confusion about the applicability of certain statutory and regulatory provisions to these PANDAs. In particular, there is confusion whether PANDAs are subject to the requirements that apply to other 505(b) applications or to those that apply to 505(j) applications. FDA recognizes there are differences between certain requirements for 505(b) application and 505(j) applications, including with respect to requirements regarding labeling updates, patent listing, eligibility for exclusivity, and certain drug safety-related requirements or procedures. FDA is seeking input from holders of these PANDAs and other interested persons regarding whether there are regulatory or policy rationales for treating these PANDAs differently from other 505(b) applications in certain respects. To facilitate stakeholder feedback, FDA has included specific questions in the Federal Register Notice. These questions are not meant to be exhaustive, and FDA is also interested in any other pertinent information stakeholders would like to share on this topic. In all cases, FDA encourages stakeholders to provide the rationale and basis for their comments, including any available supporting data and information. Interested persons can submit comments to the docket until December 11, 2021. As explained in the Federal Register Notice, FDA has also begun adding RLD designations for PANDAs to Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and will continue making these designations as expeditiously as resources permit. Following a January 2017 update to the Orange Book to separately identify reference listed drugs and reference standards, only products identified as being approved under a new drug application (NDA) have been designated as RLDs. Although these changes to the Orange Book were intended to provide clarity, they revealed that for some drug products, no product is identified as being approved under an NDA (in either the active or discontinued sections of the Orange Book) that could serve as an RLD for a particular listed drug, even though the Orange Book reflects that there are approved abbreviated new drug applications for the drug product, including abbreviated new drug applications identified as reference standards. One reason for this lack of RLDs is that some of the products listed in the Orange Book and identified as being approved under an "abbreviated new drug application" are actually drugs that were approved for safety and effectiveness under section 505(c) of the FD&C Act in PANDAs that had been designated as RLDs before the 2017 update to the Orange Book to separately identify RLDs and reference standards. FDA determined it was appropriate--and consistent with FDA's past practice and general policy regarding the designation of RLDs--to designate PANDA products as RLDs because these products were approved for safety and effectiveness under section 505(c) of the FD&C Act. Designation of PANDA products as RLDs also provides clarity both to prospective 505(j) ANDA applicants seeking to make generic versions of these products, and to applicants of 505(b)(2) NDAs that FDA's finding of safety and effectiveness for these drugs may be relied upon for approval. In addition, it is aligned with FDA's efforts to help advance competition and increase patient access to more affordable medicines. To aid stakeholders in identifying PANDAs, FDA has also posted a list of the products currently included in the Orange Book and identified as being approved under an abbreviated new drug application that were approved for safety and effectiveness under section 505(c) of the FD&C Act in a PANDA prior to the enactment of the Hatch-Waxman Amendments. This list is available under "Additional Resources" on FDA's Orange Book web page. |
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