The US Food and Drug Administration (FDA) recently asked for input from stakeholders on how it should handle certain drugs approved in abbreviated applications before the enactment of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendments) in 1984, which created the agency’s modern regulatory framework for generic drugs.
Notice from FDA
In a Federal Register notice announcing the request for comments, FDA refers to such products as “pre-Hatch-Waxman abbreviated new drug applications” or PANDAs. Because these products were submitted and approved under the provisions of section 505(b) of the Federal Food, Drug, and Cosmetic Act, they can be used as both a reference listed drug (RLD) for generic drugs in abbreviated new drug applications (ANDAs) and referenced in 505(b)(2) applications, which are new drug applications (NDAs) containing full reports of investigations of safety and effectiveness that may rely in part on studies conducted by other parties. The consultation applies specifically to PANDAs approved under section 505(b) and, due to their complex regulatory history, excludes antibiotics approved under section 507 of the FD&C Act.
FDA said it is looking for feedback on “several issues related to FDA’s post-approval regulation” of PANDAs and acknowledged that there is “some confusion about the applicability of certain statutory and regulatory provisions to PANDAs.” FDA also notes that such products have traditionally been regulated by the Office of Generic Drugs within the Center for Drug Evaluation and Research.
“FDA introduced the concept of an ‘abbreviated new drug application’ in 1968 as a vehicle for approval of certain drugs affected by the DESI review, and in 1970, FDA published a final rule establishing a regulatory pathway for submission of abbreviated applications for these drugs,” FDA wrote. When a drug subject to DESI review was determined to be effective, FDA would issue a DESI notice that opened the door for abbreviated applications to be submitted for those products instead of an NDA.
“For approval of PANDAs, FDA relied on the evidence of effectiveness that had been provided, reviewed, and accepted during the DESI process. FDA evaluated the safety of these drug products on the basis of information included in NDAs submitted prior to 1962, as well as the subsequent marketing experience with the drugs,” FDA notes.
FDA further explains that “although the regulations establishing the pathway for PANDAs were similar in some respects to the ANDA pathway … the requirements under the old regulatory pathway … also differed in many respects from current ANDA requirements. For example, although the conditions of use and labeling for PANDA products had to be in accord with the relevant DESI notice (which frequently covered a class of drugs that included multiple products and multiple active ingredients) … PANDA products were not required to have the same labeling as a particular pre-1962 NDA drug product listed in the DESI notice.”