Tag Archives: FDA

FDA

FDA Aligns with GS1 SGTIN For SNDC

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Last Friday, the FDA published the long awaited guidance on their Standardized Numeric Identifier (SNI) for prescription drug packages.  This was right on time since the FDA Amendments Act  of 2007 gave the agency 30 months to develop a standard for SNI and they published, almost to the day, 30 months later.  Well done.

The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009.  In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC →

legitimate pharmaceutical supply chain

The Deputized Supply Chain

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Several people I know from the traceability solution provider community like to tout the similarities between the food supply chain and the pharmaceutical supply chain.  They see similar track and trace regulation in the futures of both chains.  After all, both supply chains are regulated by the same agency (FDA, although food is also regulated by the USDA) and they see them as having similar problems.  But I don’t buy all that.  My friends see the use of common tools (their products, of course) and I might give them that, but these two problems only seem similar on the surface and so, if track and trace regulation is needed for both, the two regulations ought to have only high-level similarities.

THE FOOD SUPPLY CHAIN

The increasing frequency of the scariest problems in the food supply chain are related to accidents—like unintended contact with surfaces or organic matter that contaminate the food with nasty things like E. coli or salmonella—or food that has spoiled as the result of improper storage somewhere in the supply chain—like refrigerators or freezers that aren’t doing their job.  Consumers would benefit from the use of food track and trace in situations like these only when the contamination or spoilage isn’t detected until after the product is split up and distributed down multiple paths.  The track and trace system would improve the speed of the recall and the confidence in its completeness.

Generally, food is distributed to retail outlets inside containers that are packed by the manufacturer or processor.  I’m not an expert here so those of you who are, please correct me, but I don’t think food distributors normally break down cases and ship individual saleable units to retailers.  I think they normally ship full cases, bins and pallets.  For this reason, item-level serialization is not critical to end-to-end track and trace.  However, container-level serialization-based track and trace would be a major benefit to this supply chain.

There is one more thing about the food supply chain that I think is significant for this discussion.  Many of the trading partners at the start of the supply chain are small, independent and technically unsophisticated.  Most of the trading partners at the end of the supply chain are just the opposite:  large corporations with big IT budgets.

THE PHARMACEUTICAL SUPPLY CHAIN

On the other hand, the scariest problems in the pharmaceutical supply chain Continue reading The Deputized Supply Chain →

standards

“Why the rush for GS1 standards?”

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In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”.  The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc.  In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards.  Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States.  It’s well worth reading.

I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry.  There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another.  In effect, it’s a patchwork, yet each user can claim to be using a standard.  This was exactly the case with the railroads 150 years ago as Mike’s analogy implies.  Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard?  I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard.  That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.

Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR).  He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI).  He calls for the use of part of the federal economic stimulus money to be used for standards development.  Continue reading “Why the rush for GS1 standards?” →

pedigree laws

What are Pedigree Laws Trying to Accomplish Anyway?

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Conversations about the merits of various pedigree and authentication models usually start from dissatisfaction with some characteristic of the current GS1 DPMS pedigree model. I maintain that the design of DPMS—including its perceived flaws—is merely a reflection of the current state and federal pedigree laws and regulations. Characteristics that people don’t like—like digital signatures, a growing document as drugs move down the supply chain, and the fact that Supply Chain Master Data is not used by DPMS—are actually all characteristics of the laws and/or regulations, so any alternate pedigree model that would truly be usable for compliance would need those characteristics too.

But that’s not exactly what I want to discuss in this essay. Instead, I wanted to explain my theory of what U.S. pedigree laws are trying to accomplish in the first place. Forget about how they do it for now. What were the goals of those who wrote these laws and regulations? I’ll agree that this is impossible to know for sure but I think I can construct a pretty convincing theory. I don’t know any of the legislators or congresspeople who wrote these laws, but I have studied their work for over four years now. I have made the following observations.

  1. The highest priority goal of the Florida and California laws appears to be to detect the introduction of illegitimate drugs (counterfeit, stolen, up-labeled, diverted, etc.) into the legitimate supply chain as early as possible, preferably at the very first transaction. These laws accomplish this by requiring companies buying drugs within the supply chain to receive the full supply chain history of those drugs at the time of the purchase (contained in a “pedigree”), and, most importantly, by requiring them to verify the legitimacy of those prior transactions. In Florida that verification can be performed by direct contact, such as a phone call, email, fax, etc., or, optionally, through the use if digital signatures. In California, this verification can only be performed through the use of digital signatures. The federal PDMA, on the other hand, does not appear to obligate the buyer to do any verification of the information provided on pedigrees they receive.Finally, Florida and California both require the recipient of the shipment to confirm that the physical drugs they received match those described by the pedigrees they received. That seems obvious, doesn’t it? Why would any legislative body require all or some supply chain participants to go through all the expense to generate and pass pedigree information but stop short of requiring anyone to actually look at it? Well, oddly, the federal PDMA appears to do just that.
  2. There is a clear attempt in the laws to help identify who participated in the introduction of the illegitimate product. This is important if your goal is to efficiently and quickly investigate the suspected crime. This would aid in shutting down the criminals as quickly as possible before they are able to spread bad medical products very deeply into the supply chain. Continue reading What are Pedigree Laws Trying to Accomplish Anyway? →
Adam Fein, Daniel Matlis, DrugChannels, FDA, FDA budget, Gerald Migliaccio, Pfizer, PharmaTech, PharmTechTalk, standards, supply chain security

Who’s Responsible for Global Supply Chain Security?

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My favorite pharmaceutical supply chain blog is DrugChannels by Dr. Adam J. Fein (PhD). Dr. Fein started his blog in May 2006. I became a subscriber and regular reader sometime later that year. The focus of DrugChannels is “Pharmacy economics and the pharmaceutical supply chain”, which has often included very rational opinions on the economic viability of various pedigree laws.

My RxTrace blog has only been around for a short time and its focus is “the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance”. This is almost the inverse of DrugChannels. I’d like to think they are complementary but I suppose we can’t judge that until I generate quite a few more posts. Either way, I owe quite a lot to Dr. Fein and DrugChannels because they provided me the inspiration for starting this blog.

In a recent email exchange, Dr. Fein drew my attention to the FDA document, “Safer Medical Products: Investments for Supply Chain Safety and Security”, a 22-page apparent explanation for an increase of $166,433,000 and 346 FTE’s in the FDA’s FY 2010 budget proposal. Part of the increase “…includes investments that will allow FDA to implement new approaches to effectively regulate the safety and security of the supply chain of medical products …”. “Medical products” include human drugs, vaccines, blood and other biological products, medical devices, animal drugs and medicated feed.

New Approaches

The biggest driver of the need for the increase is the rapid globalization of the supply chain for medical products that end up in the medicine cabinets of Americans.

“The priorities proposed in this initiative will assure the safety and security of foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain…”.

“Supply Chain Safety and Security relies on risk-based prevention with a verification-focused approach to hold all segments of industry accountable for ensuring that their products meet U.S. safety standards, with FDA verifying compliance with standards.”

“FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.”

The proposal promises to hire more experts and modernize FDA information technology. But it also includes funds to fight internet drug fraud, and to allow FDA to develop policy options related to drug importation.

“FDA will develop policies to implement the Administration’s policy of allowing Americans to buy safe and effective drugs from other countries.”

So is the FDA Responsible for Global Supply Chain Security?

Lots of interesting content for everyone to mull over. Daniel R. Matlis, president of Axendia, has done just that in a post on the PharmTechTalk blog. In his post he uses the FDA document to question whether securing the global medical products supply chain should be the FDA’s responsibility or the industry’s. It’s an interesting question and Matlis juxtaposes the FDA paper against comments reportedly made by Gerald Migliaccio, Vice President of Quality, EHS and Agility at Pfizer Global Manufacturing at a recent joint session of the PharmTech Conference and the Manufacturing Execution System in Life-Sciences Congress. Migliaccio believes that, “Supply chain security is the responsibility of all parties involved in procurement/ sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product.”

Matlis concludes that industry and regulators have different roles in securing the supply chain and that we all benefit by their efforts. After raising such a provocative question, I felt let down by such a milquetoast conclusion. Like Gerald Migliaccio, I believe the responsibility for supply chain security falls squarely on every participant in that chain, global or domestic. FDA is an arm of our government—that which is of, by and for…us, the consumers, the patients. To me, it seems backwards to make the consumer/patient responsible for the safety and security of the supply of products that are advertised as being safe and beneficial to our health and wellbeing.

I’m not arguing against the existence of the FDA, only the argument that it is up to the FDA to ensure the safety and security of the supply chain. What we need from the FDA are standards that ensure that illegitimate supply chain activity can be detected automatically by the supply chain participants themselves. Arming each buyer in every purchase transaction in the supply chain with the means to reliably, quickly and independently verify each prior transaction back to the original manufacturer would accomplish exactly that. I’ll explain how that can be done in future posts.