FDA’s revised MAPP outlines procedures for generic drug labeling changes

The US Food and Drug Administration’s (FDA’s) Office of Generic Drugs recently issued a revised Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for handling generic drug labeling changes, including listing the responsibilities of the internal FDA staff responsible for managing these labeling changes.

The 16-page MAPP implements Section 10609 the Patient Protection and Affordable Care Act (PPACA) which was enacted in 2010 and added to 505(j)(10) of the Federal Food, Drug and Cosmetic Act. It updates the previous version of the MAPP, issued February 2013. (RELATED: FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD, Regulatory Focus 14 February 2013)

FDA wrote in an email to Focus that the revised MAPP "clarifies that the agreement to submit revised labeling after approval under the provisions of 505(j)(10) is a statutory requirement, now defined as a Post-Approval Labeling Requirement (PALR). As a result, the templates now reference PALR and the MAPP now includes language for a release from the PALR."

The MAPP also includes a new template to cover situations where the applicant fails to submit a labeling supplement in response to the PALR, noted FDA. Other changes were made to further clarify the roles and responsibilities for making and documenting these determinations.

The MAPP also includes the template of a new letter to sponsors on post-approval labeling requirement under section 505(j)(10).

PPACA allows FDA to approve a generic application submitted under the 505(j) pathway, even if the abbreviated new drug application (ANDA) approval occurs at the same time as certain changes approved by FDA to the labeling for the reference-listed drug (RLD). However, FDA will only issue the ANDA approval if the generic applicant agrees to submit revised labeling that corresponds to the RLD labeling changes within 60 days of notification of the change.

The law is meant to increase consumer access to generic drugs by closing a loophole used by some brand name drug companies to delay the entry of generic drugs that reference their drugs by submitting last-minute labeling changes. This has had the effect of forcing applicants to resubmit their ANDAs with the new labeling information.

Under prior law such as Pliva v. Mensing, the Supreme Court ruled generic pharmaceutical manufacturers are not liable for state tort claims based on labeling because federal law requires the drug’s label to be identical to the Reference Listed Drug (RLD).

FDA’s MAPP 5230.3 Rev. 1

FDA’s revised MAPP outlines procedures for generic drug labeling changes

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