FDA Posts Policy for Implementing PPACA’s Closure of Generic Loophole

The Office of Generic Drugs (OGD) at the FDA’s Center for Drug Evaluation and Research (CDER) has issued and posted a Manual of Policies and Procedures (MAPP 5230.3) describing how the staff at OGD should implement section 10609 of the Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148).


Section 10609 of the PPACA, which added section 505(j)(10) (21 U.S.C. sec. 355(j)(10)) to the Federal Food, Drug & Cosmetic Act (FD&C Act), permits the FDA to approve an abbreviated new drug application (ANDA) for a generic drug even if the approval coincides with changes to the labeling for the reference listed drug (RLD), as long as the generic applicant agrees to submit revised labeling corresponding to the RLD labeling changes within 60 days of notification of the change. An RLD is a medicine that has been approved by the FDA and appears in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). Generic companies must designate an RLD when submitting an ANDA so that the FDA will know to which brand drug the generic will be compared.

The Loophole

This PPACA-related amendment to the FD&C Act was first introduced on October 14, 2009 by Sen. Jeanne Shaheen (D-NH) in the Access to Affordable Medicines Act (S. 1778). S. 1778 and section 10609 of PPACA were both intended 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 into the market. The loophole involved submission of last-minute labeling changes by brand name drug manufacturers in an effort to force generic drug applicants that use the brand drug as their RLD to resubmit their ANDAs with the brand manufacturer’s new labeling information.

The New Policy

The new FDA policy (MAPP 5230.3) requires that: (1) the approval of the RLD’s labeling revision is made within 60 days before the expiration of a listed patent, an exclusivity period, or a 30-month stay delaying ANDA approval; (2) the approved revision to the labeling of the RLD must not include a change to the “Warnings” section; (3) the FDA has determined that the continued presence of the labeling in effect before the revision will not adversely impact the safe use of the drug product; and (4) the generic sponsor must provide a letter of commitment to submit a “Supplement – Changes Being Effected” containing the revised labeling no later than 60 days after the date of notification by FDA.

The Procedure

Unless the ANDA applicant submits revised labeling prior to approval, the ANDA sponsor or an OGD staff member may request a 60-day grace period for submission of generic drug labeling revisions.  The Labeling Review Branch (LRB) reviewer evaluates whether section 505(j)(10) criteria are met.  The LRB team leader then determines whether the reviewer’s recommendations are appropriate. If the reviewer and team leader are not able to agree, they will bring their concerns to the director of the Division of Labeling and Program Support for resolution.

If the labeling reviewer and team leader agree that the criteria have been met, the labeling reviewer will issue a letter to the ANDA sponsor requesting a commitment to update the labeling within 60 days of notification. If the letter requesting a commitment would not reach the sponsor before the date the drug product is eligible for approval, the labeling reviewer must contact the sponsor by email or phone and follow up by letter.

At the time of labeling endorsement for final approval of the ANDA, the labeling reviewer will ask the Product Quality Review Project Manager (PQRPM) to include postmarket labeling agreement language in the approval letter if it has not already been added.


The PQRPM then informs the labeling reviewer via email when the ANDA is approved. The reviewer completes the postmarket commitment form and emails the form to the Labeling Project Manager (LPM). The LPM enters the agreement into the FDA Document Archiving Reporting and Regulatory Tracking System (DARRTS). The LPM notifies the ANDA sponsor that submission of the labeling supplement within 60 calendar days from the date of notification is required as a condition of approval and follows up to assure that the condition has been met.

The MAPP is effective February 12, 2013.