The U.S. House of Representatives passed their H.R. 1919, Safeguarding America’s Pharmaceuticals Act a few weeks ago (see, “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives” and also don’t miss “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”). The Senate is next up with S. 957 Drug Supply Chain Security Act (or S. 959 depending on if they really did combine it with the compounding act as they passed it out of committee).
We still don’t know exactly when this bill will be debated or considered in a vote on the Senate floor but indications are that it will be sometime in July. According to the Senate calendar the Senate will potentially be in session the Monday after Independence Day (July 4) through the rest of the month. They could also potentially be in session the first two days of August before recessing until the second week of September. So July it must be.
As we wait for the Senate to get past the immigration bill and take action on the Drug Supply Chain Security Act I thought I would compare the timeline of that bill with the California pedigree law timeline. It’s interesting to see that the two timelines are similar in that they both stagger the requirements by industry segment. In my view, that’s a bit of a mistake but it’s not a disaster. As I pointed out in Plateaus of Pharma Supply Chain Security,
“…to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success”.
On the other hand, the approach encoded in the Senate bill (but not quite in the House bill) does make a nod toward a plateau-based approach by adding in the use of serial numbers in ePedigrees after ten years. That’s a long wait and once it finally happens, it would be a big and abrupt leap for distributors and dispensers to make happen. And if the bill becomes a law I’m sure the industry will point that fact out as they ask for more time to implement—but not until about two years before that date. Now is too early for the industry to make that claim because today’s goal is to kick the can down the road from the California dates. Those initial dates are only about 18 months away, and when you kick a can, you should expect to kick only when you get close to it, and then the goal of the kick is just to get it out a little farther ahead of where it was before. So I’m sure we’ll address the issue of the big abrupt leap again around 2021 as part of the next kick. You watch.
So how exactly would the timeline for S. 957 compare with that of the California pedigree law? Here they are shown together on a single time scale. The California dates are shown in red above the line and S. 957’s proposed dates are in blue below the line. I have taken some liberties in my characterization of each major timeline event. You should read the bill yourself before you take any action based on my analysis here so you can confirm that you agree with my perception. Click the diagram to enlarge it.
It is hard to boil the whole bill down to just a few major events so a lot has been lost in that translation, but even boiled down, I think it is instructive to see these two timelines together. You can see why the industry is making the big effort now to get Congress to preempt the California law. If it does not happen this summer—this Congressional session—then by next summer most pharma manufacturers will have already spent most of the money it will take to meet it.
Something I think is worth repeating here is that most pharma manufacturers and repackagers will need to deploy full-country serialization programs to meet the California law. That’s because neither they, nor their wholesale distribution trading partners know where each unit of drugs will end up so they have to serialize and pedigree all of their production targeted for the U.S. market. That’s true for meeting the California law and the serialization part would be true of S. 957, but with the Senate bill manufacturers would have an additional 2 ½ years beyond the California deadlines to add serialization and an additional 8 ½ years to do the full ePedigree. Repackagers would have an additional two years to add serialization and an additional seven years to do full ePedigree.
Contrast that with what happens for wholesale distributors and dispensing organizations under the California law and what would happen if S. 957 becomes law. Under the California law these organizations would need to deal with serialization and ePedigree only within the borders of California and points outside of California that end up shipping drugs into the state. Under S. 957 these organizations would need to start dealing with some lessor elements of the bill as the plateaus go into effect, but for the larger organizations these would occur on a nationwide basis.
Under S. 957, distributors would have some comparatively mild things to deal with implementing three years after their current California deadline and would be able to defer full nationwide serial number-based electronic pedigree for four years beyond their California obligation. Dispensers have even more mild things to deal with three years after their current California deadline and would defer the nationwide serial number-based electronic pedigree for three years beyond their California obligation.
I am intentionally trivializing the changes that distributors and dispensers would face in 2019 and 2020 because, compared with the work that they would need to do for California in 2016 and 2017, they are trivial, even when done on a nationwide basis, especially compared with the work and expense that manufacturers and repackagers would have to do. Please feel free to let me know if you disagree with my trivialization.
Of course, the real test of the value of any attempt to protect the pharma supply chain is not whether it is costly, difficult or trivial. It would be great if a trivial change would solve all supply chain security problems. The test is whether or not the crimes that are being committed today will be blocked once the changes go into effect and whether or not patients are protected better than they are today. If I have time, I’ll take a look at that prospect in a future essay.
But I have to ask again, what is the purpose of pushing out the full serial number-based electronic pedigree until 2023 in this bill? That seems pretty far, even if all you are doing is kicking a can down the road.