Monday, September 24, 2007

PDUFA & Supply-Chain Security

Like you, I spent Sunday reading through the just-passed Food and Drug Administration Amendments Act of 2007, a.k.a. Prescription Drug User Fee Act (PDUFA), which now awaits the President’s signature. What, you had something better to do on the last Sunday of the summer?

In case you missed it, section 913 is entitled “Assuring Pharmaceutical Safety.” See page 355 of H.R.3580 (424 pages) or simply print this handy-dandy 4-page extract.

Subsection (a) states: “The Secretary [of HHS] shall 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.”

Ah yes, just what the industry needs – more standards! Standards must be totally awesome because we have so many of them in the pharma industry.

In plain English, the Act requires the following:
  • The development of a standard numerical identifier at the package or pallet level
  • The identifier must link repackaged products back to the original product
  • The standard must be developed within 30 months (September 2010?)
  • The evaluation of “promising technologies,” including RFID, nanotechnology, encryption technologies, and “other track-and-trace or authentication technologies.”
  • Interagency cooperation by FDA with Federal and State agencies
I asked a few people around the industry for their opinions. No one wanted to be quoted on the record (‘natch), but here are a few reactions:
  • “As a manufacturer, I am pleased with the 30 month timeframe to evaluate/develop a standardized numerical identifier. I also like the fact that it encourages some degree of harmonization with coding requirements outside the U.S.”

  • “I don't know who drafts this language, but either (A) they intentionally include vagaries so that makes it impossible to execute, or (B) they don't really understand what their talking about. I think it is the latter.” (AJF: ROTFL!)
Adding to my confusion is that fact that H.R.3850 raises a whole new set of state vs. Federal preemption issues regarding our drug distribution system. States have been moving forward in multiple directions on pedigree while the FDA struggles to implement the 20-year old PDMA. Yet the FDA is now supposed to lead them all?

We are already dealing with California law, which requires a “unique identification number…that is uniformly used by manufacturers, wholesalers, and pharmacies.” Pedigree in California must be at the “smallest package or immediate container,” but probably only for high-risk products. (See California Dreamin'.)

So, how will the new Federal ID number relate to the numbers developed in California? Or interact with the mysterious Rx SafeTrack initiative being pursued by HDMA, NACDS, PhRMA, and GPhA? Will this Act upsize the smallest package to a pallet because of the pesky "or" written into the legislation?

Brenda Kelly of SupplyScape, which is helping companies get ready for California’s January 2009 deadline, strikes an optimistic note: “This reinforces patient safety efforts like California’s. With two and a half years to define a standardized numerical identifier and consider a wide range of technologies, the Agency can benefit from the states’ initiatives.”

I certainly hope that Brenda is right. Since my web logs show many visitors from State and Federal agencies, anyone care to post some comments on the new Act for their benefit? (Yes, you can post anonymously, if you want.)


  1. Adam,

    The way I see it is that the FDA now has the time to evaluate what CA is doing for 2009, and can use the CA standard, which everyone in industry is managing towards to become the FDA standard. This allows the FDA to be a follower again and not a leader.

  2. I think the other event of interest last week was the California Board of Pharmacy Enforcement Committee meeting. PhRMA recommended lot level pedigree and phased in serialization to begin in 2012. HDMA delivered a presentation on how lot-level will not work. GSK committed to serialization. They said London Times article was false.

    Clear battle lines are being drawn. I can understand why certain technology vendors will be optimistic (their future depends on enforceable pedigree requirements in the next 18 months). However, I understand one technology provider for Florida pedigree requirements has decided not to play in the California market because of uncertainty (and a lack of a sustainable business model). Anyone looking for black and white answers over the next 12 months (any lessening of the California requirements other than a delay to 2011 will require a change in legislation. The last legislative session in California before 2009 wraps up in September, 2008) will be disappointed. Be prepared for a flurry of press releases and article by tech providers and lobbying by the industry.

    Let the games begin.