And So It Begins: FDA Issues First DSCSA Guidance

By William T. Koustas –

FDA has issued a new draft guidance titled “Drug Supply Chain Security Act Implementation:  Identification of Suspect Product and Notification” (Draft Guidance).  This Draft Guidance is the first of many to come in FDA’s implementation of the Drug Supply Chain Security Act (DSCSA).  As was apparent at the recent DSCSA public workshop (as we posted here), industry has been anxiously awaiting more information from FDA as DSCSA provisions, including provisions regarding suspect and illegitimate products, begin to take effect the first of the year.

One of the initial requirements is to notify FDA and trading partners of product that is identified as “illegitimate.”  FDC Act §§ 582(b)(4), (c)(4), (d)(4), (e)(4).  Under the DSCSA, if a trading partner identifies a product that is suspect, it must quarantine the product and conduct an investigation to determine whether the product is illegitimate.  Id.  Upon determining that the suspect product is in fact illegitimate, the product must remain quarantined, be appropriately disposed of, and a notification must be made to FDA and trading partners.  Id.
 
The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending ways trading partners can identify and determine whether product is suspect; and (3) creating a process for trading partners to terminate illegitimate product notifications.  FDC Act § 582(h)(2).  The Draft Guidance addressed each of these three issues as follows:

(1)  Potential scenarios that increase the risk of finding suspect products:  FDA identified a number of potential scenarios that could lead to vulnerabilities in the supply chain.  FDA groups the scenarios into three categories:  (1) trading partners and product sourcing (e.g., purchasing from a new trading partner); (2) supply, demand, history, and product value (e.g., product is in high demand in the U.S.); and (3) product appearance (e.g., product packaging appears different from the usual packaging).

(2)  Recommendations for identifying and determining if product is suspect:  FDA also took a three-part approach here, and identified three areas in which products might be suspect:  (1) pricing (e.g., sold at very low prices); (2) package and transport containers (e.g., compromised packaging); and (3) labeling on individual saleable units (e.g., missing information on the label).

(3)  Notification of illegitimate product and termination:  The DSCSA requires trading partners to notify FDA and other trading partners once they determine that a suspect product is illegitimate.  The Draft Guidance sets forth a process for trading partners to make such notifications via a new form (attachment A to the Draft Guidance) and a new website.  The DSCSA also requires trading partners to consult with FDA in order to terminate an illegitimate product notification, but the Draft Guidance appears to take that a step further.  FDA views this requirement under the DSCSA as requiring “trading partners [to] provide FDA with an opportunity to provide its expert views and advice on proposed terminations of notifications.”  FDA committed itself to responding to requests for termination within 10 business days (with the caveat that, if it would take longer, FDA would notify the trading partner). 

Also of note, as FDA makes clear throughout the Draft Guidance, it views the portions of the guidance related to termination of illegitimate product notifications as binding upon finalization.  Generally, guidance documents are non-binding. 

While FDA fulfilled all the requirements that the DSCSA set forth for this guidance, and even arguably went a step beyond with respect to termination of notifications (i.e. new form, website, FDA 10 day response time), the Draft Guidance leaves at least one significant gap that we expect trading partners will want FDA to eventually fill.  As the DSCSA is written, a suspect product must be determined to be “illegitimate” to warrant a notification to FDA.  While the Draft Guidance discusses scenarios regarding whether a product is suspect, it does not bridge the gap and articulate when a suspect product becomes an illegitimate product as defined under the DSCSA.   

As FDA acknowledged, this guidance does not address all suspect and illegitimate product-related issues, but it is a start.  Interested parties should submit comments on the Draft Guidance within 60 days of its publication in the Federal Register (79 Fed. Reg. 33,564 (June 11, 2014)).