Last week the Pew Prescription Project, an arm of the Pew Charitable Trust, released a report on the risks of substandard and counterfeit drugs.  This is a meticulously researched report that will likely be used by legislators and regulators to better understand the problems and potential solutions of U.S. pharmaceutical supply chain security.  For this reason it is a must-read for anyone interested in the topics that RxTrace routinely explores.  You can get a copy of the full report PDF, view the associated webcast and graphic here:  After Heparin: Protecting Americans from the Risks of Substandard and Counterfeit Drugs.  I’ll have more to say about the webcast in a subsequent essay.

According to the “Introduction and Background”,

“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses.  This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”

The report is 77 pages of text with 24 additional pages of references.  The text is peppered with numbered references for those who want more details on a particular topic.

There are three Chapters.

1. Pharmaceutical Manufacturing:  Globalization and Quality Management
2. Barriers to FDA Oversight
3. Pharmaceutical Distribution

Chapter 1 contains excellent coverage and analysis of the new problems that have cropped up as the result of the rise in global manufacturing of Active Pharmaceutical Ingredients (API’s), excipients and finished drugs in the last 20 years.  These are locations where existing FDA regulations and programs are not designed to cover.  As the report says,

“In regions where regulation, compliance and vigilance are weak, the quest for lower-cost materials can drive the trade of substandard or falsified drug ingredients.  These may be introduced into manufacturing processes or sold as legitimate products by distributors and brokers.  In countries with less developed regulatory systems than that of the United States, manufacturing standards may also be less rigorous–or less rigorously observed.”

Analysis of the causes and the impact of the Heparin API tampering case of 2007/2008 is sprinkled throughout the chapter in addition to a number of other case studies that highlight related problems.  It’s a chilling chapter that ends with Pew’s policy recommendations.

Chapter 2 is focused specifically on the limitations and deficiencies of today’s FDA.  This includes insufficient scrutiny of overseas manufacturing, insufficient staffing levels to meet the rise in foreign manufacturing, outdated IT systems for tracking drug manufacturing sites, and limitations of current enforcement tools and authorities.  At the end of this chapter Pew provides an extensive list of policy recommendations that they believe would address these deficiencies.

In Chapter 3 the report takes a different perspective, focusing on the domestic finished drug supply chain rather than a global view.  This chapter hits the sweet-spot of RxTrace and so I read it with great interest.  The chapter touches on a wide variety of crimes that occurred in the last dozen or so years and includes two case studies of crimes that occurred back in the early 2000’s.  As regular RxTrace readers should recognize, that was a time when weaknesses existed in the U.S. supply chain that no longer exist, but the paper misses the opportunity to provide an in-depth analysis of these important changes and their consequences.  The reader is left to assume that these crimes could still occur as easily as they did back during that time.

The paper cites the 2006 report by the FDA’s Counterfeit Drug Task Force which expressed concern that U.S. drug distribution may be increasingly vulnerable to the introduction of sophisticated counterfeits–something that a knowledgeable person would have said at that moment in time as they surveyed the criminal activities of the previous 5 years.  The trouble is, the Task Force members were probably unaware of the elimination of secondary sourcing by the national drug distribution companies that was occurring at the same time that paper was being written.  The authors of the Pew paper did not have the same handicap so it’s hard to give them the same pass for not covering it.  For more on this important change in the U.S. supply chain that is not adequately covered in the Pew paper see my essay “Do We Even Need To Mandate Drug Pedigrees Anymore?“.

I was also a little surprised that the Pew paper did not mention the investigative work that Katherine Eban recently published in Fortune Magazine online in “Drug Theft Goes Big” because the lessons contained in those events are more pertinent to today’s supply chain problems than the events of 2002, but I suppose the omission was due to the timing of publication deadlines.  For my analysis of those important lessons see “Lessons from ‘Drug Theft Goes Big’“, “Reliance on Trust in the U.S. Pharma Supply Chain” and “Illegitimate Drugs In The U.S. Supply Chain: Needle In A Haystack“.

Finally, I was disappointed in the poor description of “What Is Track And Trace?” in Sidebar 5.  The description is muddled and it never actually provides a proper definition of the concept.  For another definition, see “Terminology: Track and Trace, and Pedigree“.  The GS1 Global Traceability Standard for Healthcare provides what is perhaps the most pure definition of these concepts.

Like the others, this chapter finishes up with a set of Pew Policy Recommendations.  These include:

• Serialize all drugs
• Require verification of the transaction history of all drugs
• Improve standards for wholesaler licensure and oversight
• Mandate FDA notification when illegitimate drugs are suspected

Overall this is a must-read report despite my petty criticisms.  It is the kind of paper that could become the impetus to movement in Congress in the coming years.  If that happens, it will be a historic document that you will wish you had read.

Dirk.