The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts. The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority. It finally looks like it is going to happen.
The official Senate calendar for today includes the following as the first order of business:
“ CALENDAR OF BUSINESS
Monday, November 18, 2013
SENATE CONVENES AT 2:00 P.M.
H.R. 3204 (ORDER NO. 236)
An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. (Nov. 14, 2013.)
UNANIMOUS CONSENT AGREEMENTS
H.R. 3204 (ORDER NO. 236)
1.–Ordered, That on Monday, November 18, 2013, if cloture is not invoked on the Wilkins nomination, the Senate resume Legislative Session and immediately vote on the motion to invoke cloture on H.R. 3204, an Act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes; provided, that if cloture is invoked on the bill, all post-cloture time be yielded back, the pending amendments be withdrawn and the Senate vote on passage of H.R. 3204. Ordered, That with respect to the cloture motion on H.R. 3204, the mandatory quorum required under Rule XXII be waived. (Nov. 14, 2013.)”
The Senate will convene at 2:00pm EST and the action on H.R. 3204 is slated to begin around 5:30pm EST, although you can’t always count on those times. Whenever the Senate is in session you can watch their streaming video online at http://floor.senate.gov/MediaPlayer.php?publish_id=2. You can bet I’ll be watching later today.
I have written a little bit about H.R. 3204 in Rxtrace (see these essays) but, believe it or not, I have been holding back a little. I didn’t want to write very much about the details because until recently it wasn’t obvious that it was going to pass. If the bill is passed by the Senate without amendments, the only thing that will stand in the way of it becoming law will be a signature from President Obama. I’m not aware of any hint of his plan for the bill, but I can’t believe there would be any reason he would veto it.
The President would have three choices of action. Vetoing it would kill the bill entirely and proponents would have to start all over again in the Congress. Or the President could either sign it into law or ignore it, in which case it automatically becomes a law after 10 days. Very few Presidents in history have let a bill become a law by ignoring it so that isn’t likely here either.
If the bill is passed by the Senate tonight I believe you can finally count on it being a law within 10 days. And then the clocks start. The bill contains lots of references to provisions that become effective after some number of years (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act”).
There are lots of things that would be triggered by passage of the law. No doubt, the most important one is that the California pedigree law would immediately become inoperative. That is, all of the “clocks” in that law—like January 1, 2015 for 50% of all drugs being serialized and pedigreed, etc.—would stop and disintegrate into irrelevance along with those of all other state pedigree laws. For that reason, many of my past essays in RxTrace will also become irrelevant at the same moment.
My current plan is to identify every RxTrace essay that would contain obsolete information about state pedigree laws and add a banner to the top of them that explains that some or all of the information contained in them is no longer applicable. I’m not sure how many essays that will be but I’m assuming as many as 75% of them. I am just skeptical enough to not want to put any energy into that process until the bill passes the Senate without amendment.
And then I will begin writing about topics surrounding the DQSA. And there are a lot of them. Industry implementation of the supply chain security part of the DQSA will not be a piece of cake. Fortunately I haven’t met anyone who thinks that it would be, although I have heard rumors of companies who would consider backing off of their programs if/when H.R. 3204 passes.
Backing off would be a mistake, but reevaluating your entire serialization and e-pedigree program and repositioning it to meet the new requirements and timeline is a good idea. I will write about that topic as soon as the bill becomes a law. Watch for it, maybe later on this week!