A number of RxTrace subscribers asked me to provide an update on the current state of the federal pedigree legislation since things have been so quiet lately. As you may recall, the U.S. House of Representatives passed their H.R. 1919, “Safeguarding America’s Pharmaceuticals Act” about six weeks ago (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“). The Senate Health Education Labor and Pensions Committee sent their S. 959 “Pharmaceutical Compounding Quality and Accountability Act” to the Senate floor two months ago (see. “InBrief: A Track & Trace bill Has Made It To The Senate Floor“).
So currently we are waiting for the Senate to take action. Lots of people thought that, if the Senate would act, they would vote before their summer recess on August 2nd–next Friday. I’ve been monitoring the Senate daily schedule each day and so far it has not come up. When it does, I’ll let you know with an “InBrief” notice.
At least the Senate has finally published the draft of S. 959 that combines the track & trace bill with the compounding bill. Find it here.
It’s interesting to note that the sponsors originally felt that this kind of bill would need to be attached to some other “must pass” legislation like a user fee act (UFA), but that didn’t happen this time. The target UFA year was the Animal Drug User Fee Act (ADUFA) or the Animal Generic Drug User Fee Act (AGDUFA), but those bills passed last month without attachment. Those bills had a deadline of the end of September to be signed so that FDA funding would continue uninterrupted, thus making them “must pass”.
Now that the track & trace legislation is not attached to a bill like that there really isn’t a deadline for passage, so this could go on for quite a while. I looked at the progress of a number of bills that went through conference committees last year–the likely path of this legislation–and they took months to make it out of conference and back to the two houses for final vote.
But it is hard to predict what will happen with this particular legislation. We’ll just have to continue to wait and be surprised.