FDA’s Office of Pharmaceutical Quality Ramps Up Process to Accelerate ANDA Reviews

In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle.

OPQ, which officially starts operations January 2015, is the agency’s new central office for all drug quality issues, and part of its mission is to speed up ANDA reviews.

One key tool the office will employ are the so-called real-time communications outlined Friday that will be issued to applicants directly from OPQ rather from the Office of Generic Drugs (OGD), and they replace the previous controlled correspondences that had to be used for even minor queries.

ANDAs only will be eligible for the real-time communications when the FDA’s question at hand doesn’t require a major expenditure of agency resources and won’t result in the agency missing the ANDA’s assigned target action date.

Such cases might include a request for additional chemistry information or a clerical clarification on an application.

If the query doesn’t meet these criteria, it will instead be submitted formally as a minor controlled response, said Susan Rosencrance, director of the OPQ’s Office of Lifecycle Drug Products. Queries that would incur a significant amount of FDA resources, meanwhile, would still be treated as a major deficiency.

The stringent requirements to qualify for a real-time communication are meant to encourage more high-quality ANDAs, she told generics makers on a recent conference call.

All ANDAs filed after Oct. 1 are eligible for real-time communications under the new GDUFA response times goals. The FDA also said it will apply this process as much as possible to ANDAs filed prior to Oct. 1 on a case-by-case basis.

Real-time communications will generally be transmitted by secure email. Upon receipt, ANDA filers will typically have up to 30 days in which to respond to a query, said Glen Smith, deputy director of the Office of Lifecycle Drug Products. The FDA will have 45 days in which to respond to the first answer and 30 days for the second, he added.

Normally, real-time communications will be limited to no more than two per ANDA, said Robert Gaines, an acting director in the agency’s Office of Program and Regulatory Operations

The response framework is part of a series of moves announced by the FDA in recent months aimed at speeding generic drug approvals and responding to industry calls for greater transparency. Rosencrance said the agency wants to drive down the number of review cycles ANDAs need before approval, with most filings currently taking between two and five cycles.

The FDA’s decision to shift chemistry, manufacturing and control functions from OGD to the newly formed OPQ has not been without controversy. The realignment prompted then-acting OGD director Greg Geba to resign after less than a year on the job.

FDA officials on the conference call cautioned that the real-time communications initiative will not replace OGD’s formal communication methods. Nor will it provide application status updates, despite a frequent criticism by generics makers that finding out where an ANDA stands in the process can be virtually impossible. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.