On April 26, 2013, Stanley C. Weisser, R.Ph. and President of the California Board of Pharmacy, replied to the Senate Health Education Labor and Pensions (HELP) Committee regarding their discussion draft of a potential federal pharmaceutical track & trace law that had been published one week before. Writing on behalf of the California Board, the letter is eight pages long and includes some very detailed expressions of concern over a few specific sections of the draft. It is well worth reading carefully. You can ask the Board of Pharmacy for a copy, or you can see the copy I obtained here.
This is a significant document because it provides the best clues we have into how the California Congressional delegation will react to this latest draft. It is my guess that, how the California delegation goes, so goes the HELP Committee on any given track & trace bill. That’s because whatever bill passes—if any bill passes—it will preempt the current California pedigree law, as well as all other state and (probably) federal pedigree laws.
I’m not trying to put words in their mouths, but I get the impression that the California delegation is not likely to support any bill that does not come as close as possible to the characteristics of the current California pedigree law. Otherwise the citizens of California will actually lose protections. I am assuming that might be why earlier drafts failed. So let’s deconstruct Mr. Weisser’s letter to figure out what it means for the possible passage of the Senate draft.
Mr. Weisser opens by complimenting the working committee and acknowledging that this version is an improvement over the November 2012 draft.
“We recognize and appreciate how much effort has gone into developing this bipartisan proposal, which has addressed many of the difficult questions that were raised by the November 2012 draft, and which is improved since the November 2012 draft. We also recognize and appreciate that the DDS Draft was clearly written with California’s interests in mind, and thank the entire working group, particularly the members of the California delegation in both houses, for considering and promoting California’s unique but shared perspective, and for our collaborative relationships. We have been pleased to work closely with the staffs of the committees and the members, and this has been gratifying.”
(NOTE: “DDS Draft” in this letter means the April 19, 2013 version of the Senate discussion draft bill.)
“…many of the comments submitted in our November 7, 2012 letter remain applicable, so we refer you to that document.”
And then, part of what we are looking for:
“We are prepared at this time to offer the Board’s reserved support for the direction offered in the DDS Draft proposal released April 19, 2013, and believe that with some modifications, this proposal offers the potential for significant public protection. We are by no means satisfied with the current form that the draft proposal takes, and believe it represents a significant step backward from the California model for electronic pedigree/track-and-trace. We are especially dismayed by the additional delay that is built into the various stages of the proposal. We believe regulators and the industry can and must do better than this, and that the public has a right to demand more. It has been over 25 years since the Prescription Drug Marketing Act (PDMA) was signed into law. We should not have to wait another 10 years for full implementation of this latest attempt to secure the supply chain, and/or it should be possible during that period to more closely mimic the California model. In the comments that follow, we will identify a few key areas where we seek improvement.
“However, as we have repeatedly stated, we strongly support the principle of a federal law in this subject area, and a nationalized model that increases the security of the entire national supply. We believe that this proposal, particularly Section 3, while it is less than an adequate replacement for California’s pedigree law, will make some positive difference in supply chain security, and we are prepared to treat this as an incremental improvement upon which we can still hope to build with continued engagement in this subject area. We also recognize and appreciate the bipartisan nature of this proposal, and the tremendous effort expended to reach a form of consensus. We do not wish to let the perfect be the enemy of the good, or to presume that we hold all of the answers.
“Therefore, on balance, while we cannot express enthusiasm for the proposal as drafted, nor do we actively oppose its passage. We recognize that the federal government has a primary role to play in this national security issue, and welcome this expansion in the federal portfolio in this area. We look forward to the continuing opportunity to engage in this shared project.
“We should be clear, however, that our support or lack of opposition is entirely conditioned on the continued inclusion of a robust, definite, and self-executing Section 3. We view this as the most important section of the proposal, and we will not support any effort to delete, weaken, delay, or make conditional or dependent on external events, the provisions of Section 3.”
“…RESERVED SUPPORT OR LACK OF OPPOSITION…”
The letter then goes on to discuss the specific sections of the discussion draft that the Board feels need further work. In these details, Mr. Weisser demonstrates a thorough understanding of the California pedigree law and the intricacies of the Senate discussion draft. Many of his concerns are precise and well-reasoned.
Finally, he concludes:
“For all of these reasons, we offer our reserved support or lack of opposition to the proposal’s direction, although we believe and reiterate that it can be made far stronger, and definitely should be implemented far more quickly. We believe the security of the drug supply and the public’s trust in that drug supply are threatened, and any further delay simply adds to the scope of these threats.
“We also believe that the endpoint should be a national end-to-end track-and-trace system that is worthy of any additional delay, and adequate to replace the California model. We believe the necessary components of any such system include: participation by all industry partners; in passing and receiving electronic drug “pedigree”/chain-of-custody data as to all prescription drugs; to which data all shipments and deliveries are validated; by tracking and validating shipments at the (saleable) unit level at each stage of distribution. We believe this proposal fails to fully articulate the system first envisioned by the FDA.”
“…Reserved support or lack of opposition to the proposal’s direction”, how’s that for a lukewarm endorsement? Lukewarm or not, could this be enough of a signal to the California Congressional delegation that the California Board of Pharmacy is ready to cave and accept the inevitable preemption with this draft? Could this be the beginning of the end of the patchwork of state pedigree laws in the United States and the beginning of the era of a more workable federal regulation? Or, is this simply an endorsement for the progress that has been made since November and not an acceptance of the latest draft? What do you think?