FDA Finalizes DSCSA Guidance on “Identification of Suspect Product and Notification” with A Twist: Additional Draft Guidance (and Potential Obligations) Added for Manufacturers

December 19, 2016By Karla L. Palmer

On December 9, 2016, FDA released a guidance document addressing its Drug Supply Chain Security Act (DSCSA) implementation: “Identification of Suspect Product and Notification.”  The Federal Register Notice announcing the release of this (partially, as explained below) final guidance explains that it is the result of review of comments on FDA’s draft guidance issued back in June of 2014 (see our previous post here). FDA intends that the guidance will aid certain trading partners along the prescription drug distribution chain, including manufacturers, repackagers, wholesalers, and dispensers in their identification of suspect and illegitimate products. If you recall the 2014 draft, it set forth several helpful examples and specific scenarios of how trading partners in the pharmaceutical supply chain should identify, notify trading partners and report to FDA suspect or illegitimate products (as defined by the DSCSA) in their possession or control. The new final guidance does not deviate from the draft guidance in its provision of examples and scenarios addressing what trading partners should consider, look for, notify and report (and how to terminate notifications) to the Agency. It does, however, add at page 12 (bullet 5) that in addition to notifying FDA, if a trading partner determines it has an illegitimate product in its possession or control, it must notify all immediate trading partners that it has reason to believe may also possess the drug (and lists reasonable methods of communication). FDA will assign an incident number to the matter to be used on all future communications.

A new, important part of the guidance, however, seeks to impose requirements on drug manufacturers, and is set forth at pages 8-11 (in grey shading). This addition is specific to manufacturers and sets forth scenarios dealing with “High Risk of Illegitimacy Notifications.” FDA states that section 582(b)(4)(B)(ii)(II) (“High Risk of Illegitimacy”) requires manufacturers to notify (1) FDA, and (2) its immediate trading partners (that the manufacturer has reason to believe may have in the trading partner’s possession a product manufactured by, or purported to be a product manufactured by, the manufacturer) in three general scenarios:

Within 24 hours after determining or being notified by FDA or a trading partner that:

  1. there is a high risk that a product that the manufacturer has reason to believe is in an immediate trading partner’s possession is an illegitimate product;
  2. there is a specific high risk that could increase the likelihood that illegitimate product will enter the U.S. pharmaceutical distribution supply chain;
  3. there exists an “other high risk” as determined by FDA in guidance pursuant to subsection 582(h). Under this somewhat vague scenario, the manufacturer would be required (but recommended) to notify FDA but not other immediate trading partners.

FDA provides specific examples for each of these three high risk scenarios and non-exclusive lists of circumstances where they may occur. The Agency explains that it believes that Congress intended this statutory section to “leverage the surveillance systems that many manufacturers already have in place to detect counterfeit and otherwise violative versions of their product.” As FDA points out, manufacturers may learn about such high risk products from trading partners, FDA, their own company, or other regulatory authorities, “even when a product may not be in the manufacturer’s possession or control.” Thus, whether or not the manufacturer has possession or control of the product, FDA provides certain examples that would require the manufacturer to notify FDA and its immediate trading partners of certain “high risk” scenarios. This obligation would be broader than that of other trading partners because notification of suspect or illegitimate product is typically only required when the product is one’s custody or possession. FDA also sets forth in the draft guidance (page 12) steps manufacturers should follow to notify FDA and trading partners of products with a high risk of illegitimacy.  Comments on the new, draft, guidance provisions are due to FDA by February 7, 2017.