In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA.  The historical issues leading to the FDA’s newly revealed concerns are clearly outlined in the FR notice, along with hints at the implications for holders of such ANDAs, which are now being referred to as “PANDAs.

The implications are far-reaching and will impact the designation of these PANDAs as RLDs, perhaps making it easier for the FDA to accept ANDAs for these old products.  The Agency notes in the FR notice that it will begin designating these PANDAs as RLDs in the Orange Book as its resources permit.  In addition, there could be patent listing and exclusivity provisions, as well as issues, some of which are addressed below, that could apply to these PANDA products.

The Agency has established a docket for stakeholder comments; as in the notice, the FDA asks interested parties for their views on a multitude of questions (while recognizing that there may be more questions or comments that could need to be addressed).  The FR notice specifically asks for comments on the following issues:

“1.  Given the legal requirements in place for applications submitted under section 505(b) and approved under section 505(c) of the FD&C Act, are there regulatory or policy rationales for treating PANDAs differently from other 505(b) applications in certain respects, in particular with respect to the following:

1.1.  Labeling requirements, including requirements related to updating product labeling to reflect certain types of newly acquired safety-related information by submitting a ‘changes being effected’ (CBE-0) supplement to FDA?

1.2.  Patent listing requirements?

1.3.  Eligibility for exclusivity?

1.4.  Certain safety-related requirements, such as the postmarket studies and clinical trials or safety-labeling change requirements in section 505(o) of the FD&C Act or the risk evaluation and mitigation strategies requirements in section 505-1 of the FD&C Act?”

And instructs stakeholders, “In responding to the questions above, please provide a specific rationale for treating these applications differently.”

“2.  To the extent that PANDA holders are expected to make changes to their current practices, what factors should FDA consider in determining a reasonable amount of time for PANDA holders to make such changes to their practices?

  1. Are there additional steps FDA should take to highlight for PANDA holders that their ‘abbreviated new drug application’ is a PANDA, i.e., that it is a 505(b) application?
  2. Are there additional steps FDA should take beyond posting the list on the Orange Book website to aid other interested persons in identifying PANDAs?
  3. Are modifications needed to the list of PANDAs posted on the Orange Book website for accuracy? For example, are some PANDAs missing from the list?
  4. Are there other issues FDA should consider in assessing the regulatory framework for PANDAs under the FD&C Act? Please provide specific examples and explain FDA’s authority to address these issues.”

As noted above, the potential implications for PANDA application holders can be ominous, like regulatory requirements for reporting of new safety issues similar to those required of an NDA holder, CBE label supplements for safety update submissions, potential REMS issues, and a host of other potential new requirements.  Read this notice carefully and provide your comments to the docket cited in the notice.

I told you – you have either seen or owned a PANDA without even knowing it!  Now you must deal with your newfound friend!