The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus

Suspect Product Draft GuidanceThe FDA published the draft guidance on the identification of suspect product and notification of suspect and illegitimate product on June 11 as mandated by Congress in the Drug Supply Chain Security Act (DSCSA).  The document provides helpful suggestions for those who wish to reduce the risk that they will unknowingly acquire illegitimate product through increased vigilance.  The suggestions are based on the experience the FDA has gained in their investigations over the years of many situations where companies have been duped by criminals into purchasing drugs that turned out to be counterfeit, diverted, stolen, adulterated, or otherwise unfit for consumption.  No legitimate company wants to be a party to buying, selling or dispensing to patients that kind of product, so everyone should pay attention to these suggestions.

As with all draft guidances published by the FDA, this one is non-binding.  It will remain so even after it is finalized and the word “draft” is removed (if that ever happens).  But there is one section that is mandated by Congress and so it will be binding—the section on the termination of a notification in consultation with the FDA.

The document is broken up into four main sections:

  • Introduction
  • Background
  • Identification of Suspect Product
  • Notification of Illegitimate Product

The first three sections provide a good explanation of the DSCSA requirement for companies to quarantine and investigate any product that is found to be “suspect” beginning on January 1, 2015.

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What is “suspect” product and how do you determine which are, and which are not “suspect”?  That’s the point of the third main section.  Companies who are serious about protecting patients, the supply chain, and frankly, their own businesses, should take this information seriously and implement an education program so that all of their employees are aware of how to identify suspect product.  Every employee needs to know this information.

If your company becomes entangled in an investigation in the future that leads to a prosecution of someone for introducing illegitimate product, which passed through your facility, and for which there were signs that went unheeded because your employees were not aware of this information, your company’s reputation will take a hit.  Worse, you could potentially get drawn into the prosecution if you passed on a Transaction Statement that contains untruthful assertions because your employees did not apply the proper due diligence and missed an obvious sign of suspect product.

The last major section contains the steps that companies will need to go through to notify the FDA whenever they confirm that a suspect product is actually illegitimate product, and for a manufacturer when there is a “high risk of illegitimacy”.  The draft guidance provides a new draft form that can be used for these purposes, as well as to terminate the notification when the illegitimate product or the high risk of illegitimacy has been addressed.  Companies may only terminate a notification after consultation with the FDA, in accordance with the DSCSA, so that’s why this one part of the draft guidance will actually be binding.


Dan Fogleberg Souvenirs albumMy first experience with Columbus, Ohio was not a good one.  When our kids were in early elementary and pre-school and we lived in Germantown, Wisconsin, we drove through Ohio on our way to a vacation in Washington DC and a family reunion in the Virginia hills.  Our first night stop was to be in a motel just east of Columbus, but as we approached the western edge of the metro area our brand new little Toyota Tercel was nudged in the back left corner by a huge moving van as the driver tried to switch lanes (into ours).  We lost traction and spun around 90 degrees where we were looking right at the side of the truck cab and then slid into its fuel tank.  We bounced off and into the ditch.  No one was hurt but we were so shook up that we couldn’t sleep that night.

The next day we quickly arranged to have our Tercel repaired at a local Toyota dealer’s body shop, rented an older car and continued with our vacation.  When we finally returned to Columbus to retrieve our “repaired” car we found that the local Toyota body shop had cheated the “out-of-towners” and we eventually had to take it to another shop back in Wisconsin to have most of the work redone.  The place in Columbus charged the moving van’s insurance company for many new parts that were actually not replaced and the bodywork was very shoddy.  We were left with a very bad feeling about Columbus.

A dozen years later I took a job with Cardinal Health, which required us to actually move to the Columbus area.  We have been here for most of the ensuing 12 years and our prior experience is like a bad dream from long ago.  Our experience actually living here had been just the opposite.  We now view Columbus as probably the best place to live in the United States.  We have enjoyed our time here greatly and we are very sad to leave our many friends and neighbors, but our family needs us back in Illinois where both our families are centered.

The second part of the subtitle above is a lyric from Dan Fogleberg’s 1980s song, “Illinois”Fogleberg (1957—2007) was from Peoria, Illinois.  I grew up in tiny Galva, Illinois (otherwise known as “not Chicago”), about 50 miles from Peoria (also known as “not Chicago”) and we shared similar feelings about our home state.  Fogleberg was one of my favorite artists while in college in Macomb, Illinois and Madison, Wisconsin.

OneGoal-EndCancerWe are relocating back to Illinois permanently because some family members need our help.  As you read this, my wife and I will be trucking our stuff to a small apartment in East Moline, Illinois (coincidentally, also known as “not Chicago”) where we will live for a few months before settling in Naperville, Illinois (known by some as “Chicago”).  We intend to return to visit Columbus at least once per year to participate in our beloved Pelotonia and visit our good friends.


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