Watching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational. Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “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”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.
Both of the current bills have been described as “bipartisan”. I don’t think that’s exactly true, but before I explain why, let’s rewind to last summer. Apparently the pharmaceutical track & trace bill that was being worked out last summer, to be attached to the Prescription Drug User Fee Act (PDUFA), was truly a non-partisan and bicameral bill. That is, there was a single text that both political parties and both houses of Congress were working on together.
The PDUFA bill was ultimately combined with a number of other bills which collectively passed as the Food and Drug Administration Safety and Innovation Act (FDASIA)—a very important bill for the FDA and all companies regulated by them (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”)—but the bi-partisan track & trace bill wasn’t included (see “PDUFA Will Not Include RxTEC”).
Apparently time just ran out. The PDUFA portion of FDASIA was a “must pass” bill to keep the FDA funded properly and it had a time limit before the FDA would need to start shutting down portions of their work in case it was not passed, so when the time came, any attachment that was not fully ready was cut. The track & trace bill was still not quite ready so it was one that was carved out of the final FDASIA bill that went on to easy passage.
All of the negotiating partners were quite disappointed by that. The next steps are a little fuzzy, but apparently two different groups kept working on new language for future bills. For some reason, no one thought that drug e-pedigree had any hope of passing by itself so everyone was looking for a “vehicle” bill—another “must pass” bill related to the FDA—that it could be attached to. The current target “vehicle” bills are the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) that “must pass” in this Congressional session (by the end of September at the latest). (See “Would A U.S. Federal Pedigree Law Require A New UFA?”.)
ADUFA and AGDUFA may not seem like they are related to the human pharmaceutical supply chain but they are directly related to work the FDA does and that makes them close enough to serve as a proper vehicle for track & trace.
TWO DIFFERENT BILLS ENTER, ONLY ONE MAY PASS
The two separate efforts led to two different bills being published as discussion drafts for comment. One draft made it to the Democrat-controlled Senate, and the other made it to the Republican-controlled House of Representatives. Of the two bills, apparently the one in the Senate is closest to the bipartisan/bicameral version that was almost included in FDASIA last summer. That bill includes a two-step process to arrive at an interoperable, electronic, unit-level serialization-based track & trace system for pharmaceuticals after 10 years. Until that time, a lot-based paper pedigree system would be in place.
The bill in the House of Representatives is only a single step, ending with the lot-based paper pedigree system, but it also encourages the FDA to propose something more in about 14 years, but with no guarantee it would be adopted. This may not seem like a big difference, but it is. I recently called the House version “an industry protection bill concealed under the veil of patient protection” (see “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”).
To have any hope of passage, the two houses of Congress must eventually get to a single text for a bill that would then have to pass both houses. It appears that may now be a lot harder than it must have seemed last summer. One way to look at it is, either the Senate will need to accept only the lot-based phase for the end-point of the bill as the House draft currently reads, or the House will need to accept the unit-level serialization-based phase for the end-point as the Senate bill reads. Or, perhaps they could come up with some middle-ground. What would that be? How hard would that be?
ENTER, MORE POLITICS
Just prior to passing it out of the Senate Health, Education, Labor and Pensions (HELP) Committee to the full Senate, the HELP Committee voted to merge their track and trace bill, S. 957, with their bill to regulate compounding pharmacies, S. 959 into a single bill, S. 959. (Check the video here at marker 50:20.) That seemed rather innocuous at the time, but according to David Pittman, Washington Correspondent for MedPage Today, the House Republicans oppose the passage of any compounding bill, arguing that new FDA authority is not needed (see Pittman’s excellent article, “House GOPs Still Oppose Compounding Bill”).
Remember, the House is currently controlled by the Republicans and the Senate is currently controlled by the Democrats. Now that recent Senate HELP Committee vote to combine their compounding bill with their pharma track & trace bill starts to look like it has politics written all over it. “In your face, House Republicans!”, the Senate Democrats seem to be saying, “Eat it”.
That move makes the conference process—the process to come up with a single text that can be passed by both houses of Congress—that much harder to accomplish. Now in addition to ironing out the differences in the two track & trace bills, either the Senate Democrats will have to accept the removal of the compounding pharmacy regulation part, or the House Republicans will have to accept the inclusion of the compounding pharmacy regulation part. If neither side gives in, then we won’t see a national compounding pharmacy law or a pharma supply chain track & trace law this session.
Which side do you think will give in, the Democrats or the Republicans? Once you see the answer to that, now figure out what will happen then.