Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach

Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed.  We all understand the history of this issue and also are well aware of the Supreme Court Mensing decision, that affirmed that generic drugs labeling must be the same as that of the reference listed drug (RLD) upon which the ANDA applicant relies as a basis for approval at time of approval, and throughout its marketing life.  The current regulations requiring sameness of labeling is consistent with the Hatch-Waxman statute as confirmed by the court.  The age-old question of how such labeling be revised when the RLD is no longer being marketed has been the subject of much debate over the years even though the regulations provide clear guidance that it is the FDA’s responsibility to inform generic applicants when such a change is needed.

Now comes the proposed statute that makes it clear it is FDA’s responsibility to identify instances where it believes that labeling of a generic product, where there is no 505(b) or 505(b)(2) application being marketed, and where there are ANDA generic products that are in the market and explains how such a process is to work.  The proposed law also has a provision that states any changes of an ANDA’s labeling ordered by the FDA will deem the revised label to have the same conditions of use and the “same labeling” as that of the RLD, even though there have been additions or other changes mandated by FDA to the label.  The theory is that if there was still an RLD it would have had to make the same changes first by supplemental application or as ordered by the FDA or the change and the generic label revision would soon follow that of the RLD.

The proposed legislation also provides for a notification period by FDA to the generic applicant during which the ANDA applicant must either make the exact change required by the FDA or appeal the decision to add the information to the FDA, or enter into discussions with the Agency to resolve any issues.  If the Agency does not agree with the appeal, the generic applicant must revise its label in accordance with the original FDA instructions or to any agreed upon change resulting from the discussions.  Failure to do so will result in the Agency deeming the noncompliant product to be misbranded.

The proposed statute also notes that there shall be no exclusivity period afforded for such changes. In addition, there are reporting requirements placed on the FDA that include:

  • No more than four years after enactment and every four year thereafter, the Agency shall report to congress on:
    • “the number of covered drugs and description of the types of drugs the Secretary has selected for labeling changes and the rationale for such recommended changes; and
    • the number of times the Secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change, if any; and
    • includes any recommendations of the Secretary for modifying the program under this section’’ of the Act.

Again, this piece of legislation if enacted would provide a clear mechanism for revision of certain generic drug labeling to assure that the label will remain current, consistent and provide such revisions as the FDA deems necessary while not running afoul of the Hatch-Waxman label sameness requirements. Changes are to be made to comply with an FDA mandated revision are to be made to paper labeling at time of next printing; and requires generic sponsors to revise electronic labels within 30 days of such FDA orders.  Changes made to comply with FDA requirements may be made by ANDA applicants in the form of a supplement changes being effected.   This legislation will provide sponsors clear guidance and direction from FDA when label changes are made and sidesteps problems associated with the “label sameness” requirements of both the current statute and its implementing regulations.  Let us hope that this piece of legislation is enacted to permit an orderly process for such label changes and to keep generic drug labeling the same from application to application.  This will avoid the type of confusion stakeholders discussed in previous proposed regulatory changes. (see previous posts, here, here  here, here, here , here and here).