Tag Archives: federal pedigree

Congress, Federal Pedigree

Waiting For The Senate To Act On A Track & Trace Bill, Again

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us-senate-logoThe U.S. House of Representatives made quick work of the new bipartisan, bicameral compounding and track & trace bill draft that was circulated only last Wednesday evening (see “InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”).  They interrupted their debate over defunding “ObamaCare”, the Patient Protection and Affordable Care Act (PPACA), for a quick voice vote on the newly numbered H.R. 3204, Drug Quality and Security Act (DQSA) and it passed (see the draft bill here).

So now we are waiting for the Senate to take action, just as we have for the last 3 months since the House of Representatives voted to pass their earlier bill with drug supply chain track & trace provisions, H.R. 1919, Safeguarding America’s Pharmaceuticals Act, back in June (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“ and “Still Waiting For The Senate”).  The Senate had their own Continue reading Waiting For The Senate To Act On A Track & Trace Bill, Again →

Congress, Federal Pedigree

InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill

US CapitolI just arrived in California a couple hours ago to attend the next California Board of Pharmacy ePedigree Committee meeting later this morning.  I was expecting to check into my hotel and go to bed, but as soon as I turned my phone back on I received multiple notices that a new bipartisan, bicameral draft of a pharma supply chain security bill was being circulated for review and comment.  The email from the Senate HELP Committee was timestamped at 9:54pm EDT on Wednesday and they want people to comment on it by noon on Thursday.  Wow.  I still hope to get some sleep tonight, but I wanted to Continue reading InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill →

NDC, UDI

UDI And The Approaching End Of The NDC

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UDI Barcode Cake
UDI Barcode Cake from last week’s UDI Conference

To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI).  Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach.  That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain.  I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard.  Of course, UDI was Continue reading UDI And The Approaching End Of The NDC →

Congress, Federal Pedigree

Federal Pedigree: Caught In A Web Of Politics

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spiderwebSeventeen 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 Continue reading Federal Pedigree: Caught In A Web Of Politics →

Congress, Federal Pedigree

Senators Propose Amendments To S. 959

BillAs many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable. Continue reading Senators Propose Amendments To S. 959 →

Congress, Federal Pedigree

Still Waiting For The Senate

us-senate-logoA 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 Continue reading Still Waiting For The Senate →

Congress, Federal Pedigree

InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year

CBO LogoJust as they did just prior to the U.S. House of Representatives vote on H.R. 1919 “Safeguarding America’s Pharmaceuticals Act of 2013” (see “InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities“), the Congressional Budget Office (CBO) just published their estimates of the public and private costs to implement S. 959 “Pharmaceutical Quality, Security, and Accountability Act” relative to the Federal Unfunded Mandates Reform Act (UMRA), paving the way for a vote in the Senate. Continue reading InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year →

Conferences

Fall Conference Season Preview

ConferenceI am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking.  That’s why it is so important to select the right conferences.  Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones.  Of course, the speakers Continue reading Fall Conference Season Preview →