The FDA and EC Dive into Supply Chain Security

Today, the Food and Drug Administration (FDA) began soliciting comments and information about technologies behind pharmacy supply chain security. Here are the links for your commenting and informing pleasure:

Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs (Request for Comments)

Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication (Request for Information)

In an interesting coincidence of timing, the European Commission (EC) recently made a similar request regarding closely related issues. See the EC’s just-issued Public Consultation In Preparation Of A Legal Proposal To Combat Counterfeit Medicines For Human Use.

These requests provide a good opportunity to educate regulators about the progress being made in our industry along with the real-world implementation hurdles. So far, the clarity and professionalism of the questions posed by the EC and FDA offer an interesting contrast with a certain Board of Pharmacy’s approach to information gathering and assessment.

What’s Going On?

In the U.S., states currently have the greatest influence over the wholesale and retail distribution of drugs, presenting some practical hurdles for any manufacturer, wholesaler, or pharmacy that operates in multiple states. Say hello to 50 different pedigree requirements!

Last September's Food and Drug Administration Amendments Act of 2007 (or FDAAAAAAAAAAA) empowered the FDA to take a stronger hand in these matters with Section 913, entitled “Assuring Pharmaceutical Safety.” Download this handy-dandy 2-page extract to read this section for yourself. I first discussed the importance of this Act in PDUFA & Supply-Chain Security.

In plain English, Section 913 requires the FDA to “develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.” The deadline is March 2010. The most notable requirements include:

• The development of a standard numerical identifier at the package or pallet level; and


• The evaluation of “promising technologies,” including RFID, nanotechnology, encryption technologies, and “other track-and-trace or authentication technologies.”

Well, this first item should be a breeze since we are only 9 months away from having all products sold in California serialized at the unit of use level for use in e-pedigree, right? Just kidding! (I’ll have more on the CA 2009 deadline next week.)

Let’s Get It On

I’ll admit to being just a wee bit critical of the FDA’s love affair with RFID. As I see it, the FDA has not always demonstrated an understanding of business realities within the pharmacy supply chain. Drug Channels readership has grown dramatically in the past year, so new readers may want to check out two RFID posts from a year ago: RFID Un-Hype and More RFID Un-Hype.

Back in June 2006 (when I had about 11 subscribers), I wrote that the FDA was blind to the supply chain’s evolution, stating: “I guess it’s easier to blame companies for not spending enough money on premature solutions than to understand the real-world complexity of having 160,000 unique points of drug dispensing.” Hopefully, we’ve all come a long way since then.

Comments are due to the FDA by May 19, 2008 and due to the EC by May 8, 2008. Happy submitting!