Seventeen months ago, the goal of the Pharmaceutical Distribution Security Alliance (PDSA) was to get a nationwide track & trace bill introduced into Congress and then get it attached to some “must-pass” legislation which would pull it through to certain passage. They found sympathetic members of both houses of Congress and they worked together to produce a single bill. Last summer the “must-pass” legislation was the Prescription Drug User Fee Act (PDUFA) which was combined with other bills and was enacted as the FDA Security and Innovation Act (FDASIA). See “What If RxTEC Isn’t Adopted?”, “PDUFA Will Not Include RxTEC” and “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.)
Unfortunately the track & trace bill was not attached because the internal negotiations were not wrapped up by the time the bill needed to be sealed off and submitted for votes. I don’t think that was due so much to politics as much as it was to sincere disagreements between the negotiating parties about exactly how to implement the regulation over time. I am told that they were very close back then.
ONE PATH DIVERGES INTO TWO
After that unfortunate missed opportunity the effort went underground for a while before resurfacing with a “fill-in-the-blank” draft in October of last year by several Representatives but not introduced (see “Congressional Legislation Development: Mad Libs Edition!” and “More Thoughts On The Congressional Discussion Draft”). It turns out, members of both the House and the Senate were working on their own separate versions of track & trace bills, and this time they were different enough that when the House bill passed, it could not just be handed over to the Senate for consideration because they had their own competing bill. With each incremental revision, the bills have gotten a farther apart.
- “The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’”,
- “House Subcommittee To Markup Track & Trace Draft Today And Tomorrow”,
- “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”,
- “InBrief: A Track And Trace Bill Has Made It To The House Floor” and
- “InBrief: A Track & Trace bill Has Made It To The Senate Floor”.)
ENTER REAL POLITICS
In isolation, the differences in the bills represent the differing visions of the various segments of the industry, patient representatives and regulators. But you can’t look at these bills in isolation. You have to look at them through the prism of U.S. Congressional politics which is where concepts like attaching bills to “must-pass” legislation are only entry-level moves. I’m not an expert in this type of politics, but we are all learning as we watch the process get applied to these two bills.
I was told back in the spring that the hope was to attach the House bill to the Animal Drug User Fee Act (ADUFA), one of those “must-pass” bills. In fact, that bill did pass, along with the Animal Generic Drug User Fee Act (AGDUFA) (yes, there really is one of those), but without either of the track & trace bills attached. So what’s left?
One theory is that the proponents track & trace saw the Senate compounding bill and figured that it was the next closest thing to a “must-pass” bill, considering the public outrage over the apparent involvement of the New England Compounding Center (NECC) in the very scary meningitis outbreak late last year, and so the Senate track & trace bill was merged with it. But there is an alternate theory that the proponents of the compounding bill saw the track & trace bill and viewed it as a “must-pass” bill so they decided to attach their bill to it to ensure passage.
Either way, it isn’t working. The move turned out to take whatever wind there was out of both sails. The pull for track & trace is not strong enough to pull the compounding bill through the controversy swirling around it and the compounding bill does not seem to have any significant push behind it to drive track & trace to enactment, probably because of the differences with the House version. So here we are past the end of the month that everyone thought was the time limit for track & trace to get enacted and we seem to be farther than ever from achieving that goal.
Back on July 25 the National Community Pharmacists Association (NCPA) called for the Senate to give up on this merge strategy and split the two bills apart again so they can be acted on separately. It appears that the NCPA likes the track & trace bill and wants to see it pass, but doesn’t like the current compounding bill and would like to see it modified in important ways that support their members.
Then last Friday NCPA CEO B. Douglas Hoey sent an “Executive Update” to the organization’s members where he credited the failure of the Senate to vote on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) before their August vacation to the actions of community pharmacy.
“Community pharmacy has succeeded in delaying Senate action on extremely onerous compounding legislation, but the reprieve is only temporary. Congress has adjourned for its five-week summer recess without passing legislation with the goal we share of preventing another New England Compounding Center-type contamination tragedy.
“I want to thank the many NCPA members who responded to last week’s NCPA Action Alerts and Executive Update and contacted Senate offices urging open debate and amendments in light of our concerns. Your voices were heard.”
NCPA is opposed to the Senate leadership’s intention to use unanimous consent last week to pass the combined bill through the Senate without amendments (see Ed Silverman’s excellent coverage of the dispute).
“It needs to get out there and be seen by people so we can hear what the industry thinks and everybody that’s a stakeholder thinks,” Coburn said. “Then I don’t have any problem, but [Harkin] shouldn’t do it too soon.”
One theory for why the bill was not brought up for action last week was that the Senate leadership and the bill’s sponsors knew that they would not get the unanimous consent without objection that would be necessary.
And I haven’t even mentioned the headwinds that would eventually come up in the conference committee that would need to resolve the differences between the House and the Senate version.
WHERE DOES IT GO FROM HERE?
Like many of you, I have heard the third-hand (at least) rumors that the sponsors of the two bills in the House and the Senate will do some negotiating over the August recess to try to come up with a compromise. We’ll know if that works out shortly after the two houses return to their full schedules in the second week of September. If anything is worked out during the break, watch for some action to come up fairly quickly. If not, then this could take some time.