September 16, 2015 Practice Points

FDA Dramatically Reduces Counterfeit Drug Alert Forecast

The FDA initially predicted that regulated entities under the law would issue 5,000 such alerts per year; it now estimates that they will issue 1,000.

By Eric W. Shannon

On Monday, September 14, the U.S. Food and Drug Administration (FDA) reduced its original prediction of annual counterfeit drug notifications, a requirement under the federal Drug Supply Chain Security Act (DSCSA). The FDA initially predicted that regulated entities under the law would issue 5,000 such alerts per year; it now estimates that they will issue 1,000.

The DSCSA requires drugmakers, distributors, and pharmacies to issue notifications when they detect red flags—such as missing product information and foreign terms on packaging—indicating that a product could be a counterfeit. The notification requirement took effect earlier this year.

In its announcement, the FDA provided little explanation for the estimate reduction. The agency did note that it revised the figure in response to questioning by a trade group. “While FDA does not know the exact number of notifications that will be submitted, we lowered the estimate to 1,000 notifications in response to the comment and our re-examination of the data,” the agency said.

The notification estimate was one of several revisions publicized in an announcement related to forthcoming final guidance on identification of suspect drugs. The FDA reiterated in the announcement that it predicts only a small minority of all companies registered with the agency will issue notices in any given year.

— Eric W. Shannon, Debevoise & Plimpton LLP, New York, NY


Copyright © 2015, American Bar Association. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or downloaded or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. The views expressed in this article are those of the author(s) and do not necessarily reflect the positions or policies of the American Bar Association, the Section of Litigation, this committee, or the employer(s) of the author(s).