The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”).  What is a lot-based pedigree and how is it different from one based on package-level serial numbers?  Let’s take a closer look at the kind of system that these bills would require.  Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to place the Standardized Numeric Identifier (SNI) (which is composed of the FDA National Drug Code, NDC, and a unique serial number up to 20 alphanumeric characters), the lot/batch number and the expiration date on each package.  The Senate bill includes text that would mandate the use of a “2-dimensional data matrix barcode” to be the data carrier on drug packages and “a linear or 2-dimensional data matrix barcode” on homogeneous cases, which seems to eliminate the use of RFID, but it also allows the FDA to identify the use of “other technologies”.  That’s definitely an improvement over what the industry’s RxTEC proposal had in it last year (see “What If RxTEC Isn’t Adopted?”).  The language in the House bill simply limits the data carrier to a “standardized graphic”, which seems to exclude RFID and does not give the FDA any authority to allow other technologies in the future.

In the Senate bill manufacturers would need to have this new product identifier applied to all drug packages within 4 years of enactment.  In the House version manufacturers would have 5 years.

LOT-BASED PEDIGREE

The key language in both bills that makes them a lot-based pedigree is how they define the term “Verification or Verify”.  The Senate bill defines it this way:

“(28) VERIFICATION OR VERIFY- The term `verification’ or `verify’ means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number, and expiration date assigned to the product by the manufacturer or the repackager…”

Supply chain companies could choose to verify drugs drug packages or cases they receive using either the SNI or the lot number and expiration date.  That doesn’t sound too bad, does it?  Everyone could decide for themselves whether or not they want to use the package serial number or the lot number to verify a drug they just bought.

The only problem is, the “transaction information” (one part of the pedigree that is passed from sellers to buyers) is defined in both bills to include the lot number but not the SNI or the expiration date, so there would be no way to verify a given package other than with the lot number.  The SNI on the packages would be superfluous for supply chain security purposes.  Not only that, but the latest version of the House bill (dated May 30, 2013) includes a new provision that would exempt wholesalers from including even the lot number in the transaction information until 5 years after adoption, so in that case none of the information needed by subsequent owners to verify a drug at the package or case level would be included!  (They wouldn’t even need to include the date they acquired the drugs until that time, which is another way of saying that wholesalers would not really have to do lot-based pedigree at all until 5 years after enactment.)

This is a lot-based pedigree system, similar in some ways to the Florida pedigree law (see “The Florida Pedigree Law”).  The lot-based system defined by these bills at least seem to solve the problem that was highlighted by the RxUSA lawsuit against the FDA enforcement of the Prescription Drug Marketing Act (PDMA) of 1987, as I predicted would be done in “Impact of RxUSA v. HHS On Future Pedigree Legislation”.  Both of today’s bills would require companies to provide their customers with transaction history only back to the wholesaler who bought the drugs directly from the manufacturer, not all the way back to the manufacturer itself.

As poorly designed as the Florida pedigree law is, even their pedigrees offer patients more security than the lot-based pedigree system defined by these two federal bills.  In Florida, once a lot-based pedigree is constructed by the first wholesaler (in Florida the manufacturer does not deal with pedigrees) for a given specific drug package, that pedigree must be appended by each company who takes custody of the drug.  Companies must keep track of who they bought every drug package from, when it arrived and when it shipped so they can update the pedigrees.  That is, the transaction history must be maintained and passed for each drug package, all without the benefit of package-level serial numbers (although there is a surprise provision in the Florida law that supposedly transforms it into a serial number-based law in the future, see “The Surprise Consequence of the California Pedigree Law”).

Each transaction appended to a Florida pedigree—whether in paper or electronic form—must be signed by a responsible person.  A signature on a Florida pedigree is an assertion, or “certification”, of the truth and accuracy of the data contained in the pedigree.  Pedigrees defined by these two federal bills would not need signatures or certifications of any kind.  Florida pedigrees are easy to forge, but these federal lot-based pedigrees would be even easier to forge.  The difference is that, in Florida, at least the forger has to sign something that can be used against them in an investigation and in a trial;  the federal pedigree would allow a criminal to disavow the pedigree data shown at trial.  Nothing would bind them to the transaction information (see “Certifications In A California-Compliant Drug Pedigree” and “Digital Signatures”).

SERIAL NUMBERS:  WHAT ARE THEY GOOD FOR?

Only the Senate version would add the SNI to the transaction information and would allow the FDA to determine how companies would verify drug packages, but only after a mandated 10 year delay.  The House bill would never enable the use of the serial number for public safety purposes.  That’s right, the drug packages would have a machine-readable serial number on them for six years before those numbers would have any chance of contributing to supply chain security if the Senate bill were to pass, and they would never be usable for that purpose if the House version passes.

Everyone seems to agree that the use of serial numbers on drug packages would improve supply chain integrity and protect patients—even members of each major segment of the industry agree with that (see “The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’”)—so I have to ask members of the Senate, why the delay?  And for the House of Representatives, why would you never take advantage of those serial numbers?  Well, for the House, the question is rhetorical since I’ve already recognized that their bill is more of an industry protection bill than a patient protection bill (see, “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”) and this is one of the reasons.

Pharma package-level serialization alone will not protect patients.  It will only serve to protect those who would do harm.  Serial numbers on drug packages without data to validate them will only give criminals one more way to offer their clients—ahem, their victims—a false sense of security.  This is the same lunacy that makes the government of India believe that by simply adding serial numbers to all exported drugs they will be viewed as more “credible” around the world (see “Ranbaxy, FDA, FDASIA and Indian Pharma Credibility”).

The serial number only provides the means with which to validate that a specific drug package and its corresponding transaction history are likely authentic, but if you never do the validation part, it will only seem like they are authentic.  The act of validation using serial numbers is the part that contributes to patient safety, not just the existence of serial numbers on drug packages, dear U.S. House of Representatives and India.

THERE IS MORE THAN ONE WAY TO DO SERIAL NUMBER-BASED “EPEDIGREE”

Serial numbers contained within the transaction information is one way to do it, but there is an even better way, which the industry has been working on for several years now.  I’m talking about the network centric ePedigree (NCeP) approaches and standards that GS1 and the industry are working on, which would maximize the efficiencies of ePedigree by keeping the equivalent of the transaction information, transaction history and transaction statements (which are terms defined in both the Senate and House bills) in a central or semi-central repository(ies).

The work of “checking” (a GS1 term) the validity of that information for a given shipment of drugs would be performed by the third-party “checking service” rather than each individual supply chain owner of the drugs (see “The Significance of the Abbott, McKesson and VA Pilot”, “How To Make The Semi-Centralized Track & Trace Model A Reality” and “Would A U.S. Federal Pedigree Law Require A New UFA?”).  This greatly simplify the work companies would need to do while increasing the security and reliability of the pedigree information and thereby significantly raising the bar against criminals who would consider attacking the supply chain with counterfeit, stolen, up-labeled, diverted and otherwise falsified and substandard drugs.

The NCeP (more recently called “Event-Based Traceability” by GS1) approach will not be ready until next year so it should not be mandated in any laws or regulation at this time, but those laws and regulations should not be designed to block their use and the FDA should be able to specify their use, if appropriate in the future, without getting a new law through Congress.  If any bill passes, it should be designed so that the FDA and the industry can work together to select technologies that protect patients at the minimum cost, including the possibility of using a GS1 NCeP-based solution.  Both bills contain some language that sound like that’s what would happen, but that language is not as clear as it could be.

LATEST HOUSE ACTIVITY

According to the U.S. House of Representatives Weekly Legislative Schedule for this week, H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, one of the bills discussed in this essay, will be debated on the House floor today after 2:00 pm along with four other bills.  According to the website, votes will be postponed until 6:30 pm.  I’ll let you know which way the vote goes.

Dirk.