The FDA hopes to increase market competition for prescription drugs and facilitate entry of lower-cost alternatives.

Following the Drug Competition Action Plan, announced by the U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb in May, the FDA has published a list of off-patent, off-exclusivity branded drugs without approved generics on June 27, 2017. The FDA plans to update this list every six months. The agency intends to expedite the review of generic drug applications for products on this list. By providing this list and accompanying changes in prioritization of approval, the FDA hopes to attract attention of generic drug manufacturers to the products where increased competition may be desired.

The list, created on the basis of the Orange Book Data Files as of May 30, 2017, contains active (non-discontinued) Orange Book-listed products having no listed patents or exclusivities and no approved abbreviated new drug applications (ANDAs), without differentiating between strength or dosage forms of a given active ingredient. The list is divided in two parts: (1) Part I of the list, containing about 150 drug products, for which the FDA would immediately accept an ANDA without prior discussion, and (2) Part II of the list, containing about 120 drug products, for which potential legal, regulatory or scientific issues need to be addressed with the FDA prior to submission of an ANDA.

The potential legal, regulatory or scientific issues include ineligibility for submission as an ANDA via 505(j) potentially requiring an appropriate abbreviated approval pathway under 505(b)(2); existence of no applicable product-specific guidance, the product being a complex mixture or imaging agent; and possibly a transition product pursuant to the Biologics Price Competition and Innovation Act of 2009. The FDA invites sponsors wishing to pursue approval of drug products identified in Part II of the list to submit an initial inquiry to the Office of Generic Drugs (OGD) at [email protected].

The FDA Publishes Manual of Policies and Procedures 5240.3 Rev. 3

In a complementary move, the FDA published the latest revision of the Manual of Policies and Procedures (MAPP 5240.3 Rev. 3), which became effective on June 27, 2017. MAPP 5240.3 Rev. 3, describes how the review ANDAs, ANDA amendments and ANDA supplements will be prioritized for review within the OGD and the Office of Pharmaceutical Quality (OPQ).

In view of increased volume and complexity of ANDA submissions, the OGD has taken a science/risk-based approach to review, and the quality review for generic submissions is now handled by OPQ. MAPP 5240.3 Rev. 3 adds a layer of prioritized review of original ANDAs, amendments and supplements. MAPP 5240.3 Rev. 3 now adds expedited review providing heightened review priority for the generic products having fewer than three approved ANDAs and blocking patents or exclusivities. The rest of the FDA’s ranking system of types of submissions that will have review priority for OGD has remained unchanged.

Whereas the previous regime only prioritized the review of first generic products for which there are no blocking patents or exclusivities for the Reference Listed Drug, now the FDA will expedite the review of generic drug applications until there are three approved generics for a given drug product. According to the FDA’s press release, the policy revision is “based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.” The press release further states that these changes follow the FDA’s proposed public meeting on July 18, 2017, “to solicit input on places where the FDA’s rules – including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.” By way of these changes, the FDA hopes to increase market competition for prescription drugs and facilitate entry of lower-cost alternatives.