Wait a Minute – Did Everyone Think This One Through?

Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks.  In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were singing the same tune on the issue of amendments (and supplements) to abbreviated new drug applications (ANDAs) submitted prior to the June 20, 2014 implementation date.

The Q&A guidance simply says that the new stability requirements apply only to new ANDAs and that “[A]ll amendments submitted to pending ANDAs after the effective date of the final stability guidance will be held to the standards in place at the time of the original ANDA submission, unless there is a concern with the submitted stability data.”  This seems rational on its face, so as not to change the requirements for applications that were submitted prior to the new stability requirements.  But in examining this further, a question arose relative to amendments that request the addition of a new strength.

The example of a potential problem that comes to mind is when an ANDA is pending prior to implementation and, say, a year after the implementation, a new strength is approved for the innovator.  Because the submission of this new strength would be an amendment to an ANDA pending prior to implementation of the new stability requirement, the applicant would only be held to the stability requirements in place at the time of the original submission.  Thus, the amendment could be filed with only three months of accelerated and room temperature stability data.  However, a new ANDA applicant submitted after implementation of the new stability requirements would be required to provide 6 months of accelerated and room temperature stability data at time of filing for the new strength.

In this case, that would place the ANDA pending prior to the implementation date at a significant advantage over the new ANDA submitted post-implementation date for obtaining 180-day exclusivity, if the reference listed drug (RLD) product was subject to a period of patent protection.  The applicant that had the pending application would have an additional 3-month window to submit its amendment because of the more limited stability requirement.  That could confer quite an advantage, and one that does not appear to be addressed in the Q&A document.  Granted, the guidance document is in draft and can be changed prior to the implementation date for the new stability requirements; however, the way it stands now, this clearly creates a potential windfall for certain applicants.

While we are certain that guidance documents, even in draft, are vetted intensely prior to their publication, as we have learned since the passage of Hatch-Waxman, no one can think of everything.  We still see court cases dealing with aspects of the original Hatch-Waxman Amendments, not to mention the MMA, FDASIA, etc., years after regulations have been in place.  I hope the policy folks at FDA read this blog so that the question can be revised to keep the playing field level for 180-day exclusivity in this unique situation.  All they would need to say is that the old stability requirements apply to ANDAs pending prior to June 20, 2014 with the exception of Amendments for new strengths.  This would keep the completeness and acceptability review for new strengths for ANDAs submitted pre- and post-implementation date on similar footing.  For that matter, what about supplements for new strengths?  Remember that Draft Guidance states:

“The stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to post approval changes.”

That means supplements in my book.  FDA needs to clarify this point, as well, prior to the issuance of the final guidance as this would also give the same advantage to a firm that had an approved ANDA and supplemented its approved application for a new strength versus a firm submitting a new ANDA that might contain the new strength.  First-to-file and the resultant 180-day exclusivity associated with being first is a statutory incentive that must be not only protected, but should also not be tinkered with without careful consideration.

For questions relative to stability or 180-day exclusivity please contact Joan Janulis at j.janulis@lachmanconsultants.com