Friday, November 05, 2010

Is Track-and-Trace a priority for the FDA?

The U.S. Food and Drug Administration (FDA) recently released its draft Strategic Priorities for 2011-2015. I recommend that you read the document for a useful glimpse into the FDA’s perspectives and the breadth of its responsibilities. You can also submit a public comment at

But there’s a notable omission from these priorities. I searched and searched through the document, but was unable to find any mention of perennial supply-chain security topics such as pedigree, track-and-trace, RFID, or serialization.

True, there is a section called "Strengthen the Safety and Integrity of the Global Supply Chain", but it deals primarily with globalization and imports.

Some Drug Channels readers may be attending the Healthcare Distribution Management Association’s (HDMA) Track-and-Trace Technology Seminar next week. If so, please ask Ilisa Bernstein, who has been on the forefront of the FDA’s efforts on supply chain security over the years, about this unexpected omission.


Things have been very quiet ever since California pushed its e-pedigree deadline over the horizon to 2015, although some manufacturers are still proceeding with small e-pedigree and/or serialization trials. Jerry Brown, who will be governor of California in 2015, doesn’t mention pedigree or supply chain security on his campaign website.

The Food and Drug Administration Amendments Act of 2007 empowered the FDA to take a stronger hand in these matters with Section 913, entitled “Assuring Pharmaceutical Safety.” (Click here to read this section.) The FDA released its guidance on their Standardized Numeric Identifier (SNI) in March, but has been quiet since then.

Meanwhile, there have been at least two notable examples of stolen products showing up in the legitimate supply chain. See How did stolen GSK product end up in pharmacies? and Why is Stolen Shire Product Being Returned for Credit?

Even more ironic? The Family Smoking Prevention And Tobacco Control And Federal Retirement Reform (P.L. 111-31) requires the FDA to prevent "illicit trade in tobacco products." The Secretary of health and Human Services may even "require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system." See Title III on page 76.

Whew! I'm so relieved that cigarettes will have RFID tags!


Another reason to be surprised by the omissions from the FDA’s strategic priorities? FDA Commissioner Dr. Margaret Hamburg used to be on the board of directors of Henry Schein (NYSE:HSIC), a major healthcare wholesale distributor. See New FDA Chief's Surprising Link to Drug Wholesaling for more background.

The FDA has limited authority over the drug distribution channel and has not even been able to implement the drug pedigree (chain of custody) requirements from The Prescription Drug Marketing Act of 1987. Yes, 1987, the same year that Beverly Hills Cop II was a hit movie.

I had incorrectly predicted that Dr. Hamburg’s background would encourage the FDA to move forward on a national strategy for the drug distribution system. Oh well. If you live by the crystal ball, then you must be prepared to eat broken glass.


  1. Great post. ePedigree went from hot to not. I am again reminded the drug track and trace was first signed into law by President Reagan when I was in high school.

    Anyone who builds a business model on government mandates will likely join the storied demise of so many ePedigree companies and products.

  2. great post! We're lucky to have the Drug Channels spoon to stir up an otherwise stagnant cesspool !

  3. Adam,
    Great observations. From this FDA strategy document it appears that they will be more focused on global supply chain integrity than domestic. Certainly the risks are potentially much higher as the Heparin contamination episode of 2007 demonstrated. However, I've heard both Dr. Hamburg and Ilisa Bernstein say in the last year that FDA is working with Congress to develop new legislation that would provide them with more "tools" to protect the supply chain.

    That could be interpreted as the "global" supply chain, "U.S." supply chain or both, but until Congress provides those tools, would it make sense for the FDA to include strategies in a document like this that would be based on tools that they have not yet been given? I don't think so. My take is that this indicates that the FDA does not believe that existing legislation provide it with enough authority to impose track and trace or pedigree technology on the domestic supply chain.

    This theory is backed up by the recent actions in the old RxUSA vs FDA lawsuit. According to the HDMA, “…the case had been put on hold in anticipation of new legislation related to the Prescription Drug Marketing Act (PDMA) that would have made the lawsuit…moot.” Apparently all parties anticipate this new legislation that would replace/update the PDMA pedigree provisions.

    Dirk Rodgers

  4. Here's a follow-up to the post above.

    ASHP's Health System Pharmacy News quotes Dr. Hamburg as saying that the FDA is creating a new drug integrity and security program that will "take a life-cycle approach by identifying vulnerabilities for products and the supply chain, starting with raw ingredients [and] continuing through when the finished drug reaches the patient." (source)

    I'm still curious why this new program or perspective didn't show up in the FDA's Strategic Priorities.