Generic Labeling Issue Is Off the Table until 2015; FDA Asks for Input on What Constitutes a First Generic Application

After almost a year of protests from the industry, consumer groups, the public and GPhA, the FDA has decided to take a deeper dive into the many comments before finalizing (or hopefully abandoning) their proposed rule on permitting ANDA holders to revise or add label warnings.  In the face of two Supreme Court decisions and lots of negative comments (see previous posts here, here, here, here, here, here, here, here and here )  the FDA has indicated that it will now delay any final decision on the Proposed Rule until September 2015.  Perhaps FDA has some trick up its sleeve to make the Rule more palatable or perhaps they are waiting to see if the Federal Courts will provide some additional guidance over the next few months.  Nonetheless, the breathing room is welcomed and the FDA’s additional consideration of the comments hopefully will bring a better result than the Proposed Rule.

In other developments today, the Federal Register (FR) contained a publication today (here) that further defined the criteria for the term “first generic” for the purposes of implementing and further clarifying that term in MaPP 5240.3 (here). In its GDUFA commitment letter, the FDA agreed to: “(1) Expedite review of ANDAs in the year 1 and year 2 cohorts (i.e., those ANDAs submitted in fiscal year (FY) 2013 and FY2014, respectively) that are submitted on the first day that any valid paragraph IV application for the drug in question is submitted (first-to-file ANDA); (2) strive to review and act on all first-to-file ANDAs within 30 months of submission to avoid inadvertent forfeiture of 180-day exclusivity eligibility under section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)); and (3) expedite review of “first generic” ANDAs for which there are no blocking patents or exclusivities.”

In the FR notice cited to above, FDA says, that there appeared to be some confusion as to what the term “first generic” really encompassed. FDA also held a public meeting on the issue and from the comments received to the Guidance and at the public meeting and has “a first generic application as any received ANDA: “(1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.”

“FDA believes that these proposed criteria appropriately focus FDA’s resources on approving as quickly as possible, new safe and effective generic drug products for patient use. The Agency also believes that these criteria are consistent with the broad scope of the Commitment Letter, and generally reflect industry intent. Finally, these criteria enable FDA to prioritize review of a pending ANDA when the date on which the ANDA can be approved alters due to changes in the patent or exclusivity landscape.”

Because the circumstances made a generic application a first generic may change over time and because these changes are mostly outside of the Agency’s control, FDA is seeking comment on whether FDA should change the review prioritization for an ANDA that no longer meets the “first generic” criteria during its review.

Keeping track of prioritization of review is going to be difficult enough for OGD- can you imagine having to change the designation and prioritization as the review progresses?  Right now, the OGD practice is that, once an ANDA is designated as prioritized, it remains that way until it is approved.  Changing the designation during the review due to changes in the landscape could result in more problems than it solves and could even lead to charges of an un-level playing field. If FDA will change the designation of a prioritized product during the review period, the criteria must be crystal clear.  As we see from the industry comments so far, clarity is something that has been hard to achieve.