InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13

PSM mug logoDr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).

Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). 

(Interestingly, few people I talked with this fall are familiar with FDASIA—even people who should be familiar with it.  That’s a shame, because, in my opinion, that act will have much more influence over the improvement of drug quality and supply chain security for U.S. citizens than the pending H.R. 3204 ever could.  See “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)

Dr. Bernstein’s presentation discussed what she called the “3 pillars of supply chain security”:

  • Prevention,
  • detection and
  • response.

Near the end of her remarks she touched on the topic of H.R. 3204, Drug Quality and Security Act, the latest pharmaceutical supply chain serialization and track & trace bill that is pending before Congress right now (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”).  I have extracted that part of her comments below.

“…In addition, Congress is currently considering legislation that would develop and implement a track & trace system in the U.S. in the [Drug Quality and Security Act].  This system, if fully implemented, cuts across all 3 pillars (prevention, detection and response).  For over 10 years, FDA has been calling for a meaningful and enforceable track & trace system to protect the public from counterfeit, stolen, diverted, or otherwise unfit drugs that may enter the supply chain.  That bill is currently before the U.S. Congress and it provides protections over our nation’s drug supply that reduce the opportunities for counterfeit and substandard products to get into the system and reach patients.

“Moving forward, we must make sure that we strike the appropriate balance between the need to establish the secure system that protects public health, and looking at the cost and feasibility of the system. 

“What this new law would do is create two phases.  The first phase that then leads into a second phase.  The first phase is to help build to get to the second phase, which we are looking forward to having it be an electronic, interoperable, unit-level track & trace system that’s clear and predictable.  The bill that is currently before the U.S. Congress provides an explicit path forward to such a system for phase 2, and takes into consideration technology available and the capabilities of stakeholders.  FDA is looking forward to working with supply chain stakeholders on this, and other efforts to further secure our nation’s drug supply…”

The PSM organization always posts high quality videos on YouTube of each presentation at their events so watch for that in the coming weeks/months.


I am told that the Senate will be back in session next week after resting since the self-flagellation they went through over the government shutdown and debt limit.  Will they debate and vote on H.R. 3204?  Let’s watch!


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