FDA Completes Implementation of Affordable Care Act Sec. 10609 “Generic Loophole” Provisions

Recently, we were perusing FDA-TRACK (Transparency, Results, Accountability, Credibility, Knowledge-sharing), FDA’s “web-based tool for tracking progress on key activities throughout the agency and making the information available both internally and to external stakeholders and the public,” and the FDA-TRACK Health Care Reform Dashboard in particular, and noticed a “completed” notation for the three milestones listed under “Section 10609 – Labeling Changes”:

1. Draft revisions to the ANDA approval letter so that when necessary, the letter can serve as the notification of a labeling change to the reference listed drug

2. Implement changes to the Document Archiving, Reporting and Regulatory Tracking System (DARRTS) database to allow tracking of post-approval commitments to revise a generic drug’s label

3. Draft a Manual of Policy and Procedures (MaPP) for the Office of Generic Drugs to describe the processes used to ensure Sec. 10609 of the Affordable Care Act is implemented fully

The reference to “Section 10609 – Labeling Changes” is to that section of the Affordable Care Act that amended the FDC Act’s ANDA provisions at section 505(j) – specifically FDC Act § 505(j)(10) – to permit FDA to approve an ANDA notwithstanding certain changes to the Reference Listed Drug (“RLD”) labeling approved within 60 days of anticipated ANDA approval. That is, approval within 60 days before the expiration of a period of patent or non-patent market exclusivity applicable to the RLD or a 30-month stay blocking final ANDA approval.

As we previously reported, the genesis of FDC Act § 505(j)(10) is a bill – the so-called “Generic Loophole Bill,” S. 1778, but officially named the Access to Affordable Medicines Act – introduced by Sen. Jeanne Shaheen (D-NH) in 2009.  When the bill was introduced, Sen. Shaheen said that it was intended to “increase access to lower cost generic drugs by closing a loophole some brand name drug companies exploit that needlessly and unfairly delays the entry of safe, lower-cost generic drugs to the consumer market.”  Introduction of the bill appears to have been related to a change to the labeling of CASODEX (bicalutamide) Tablets.  According to Sen. Shaheen, “consumer access to the generic version of this drug was delayed by more than 3 months due to a last minute pediatric labeling change . . . .”

Although FDA has, according to FDA-TRACK, drafted a MaPP to implement Section 10609, that MaPP has not yet been made public.  We were curious, however, whether FDA has used its new authority under FDC Act § 505(j)(10).  And, in fact, FDA has used it – three times so far that we can tell.  The first two instances are from November 2010 – Donepezil Hydrochloride Tablets, 5 mg and 10 mg (ANDA No. 76-786) and Donepezil Hydrochloride Orally-Disintegrating Tablets, 5 mg and 10 mg (ANDA No. 78-388).  The third instance is from this past April when FDA approved ANDA No. 77-431 for Exemestane Tablets, 25 mg.  In each case, FDA cited FDC Act § 505(j)(10) and a revision to the RLD labeling  within 60 days of the expiration of an Orange Book-listed patent that had already expired.

So, has new FDC Act § 505(j)(10) thus far resulted in speedier generic approvals, or is it just a new checkbox that FDA has to mark when clearing ANDA approvals?  You decide.