Category Archives: Congress

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 →

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 →

Congress, Federal Pedigree

InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives

Seal_of_the_United_States_House_of_RepresentativesImportant Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote.  I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing.  😉

The text of the bill as it was before the vote appears here.

During the debate leading up to the vote, Continue reading InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives →

Congress, Federal Pedigree

InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities

WASHINGTON - JANUARY 26: The Congressional Budget Office made copies of its Budget and Economic Outlook for FY 2010 to 2020 available to reporters and the public January 26, 2010 in Washington, DC. The CBO's latest estimates see a $1.35 trillion deficit for the current budget year, dropping to $980 billion next year only if a host of tax cuts enacted under President George W. Bush are allowed to expire at the end of the year. (Photo by Chip Somodevilla/Getty Images)Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).

CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”.  However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.

Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities →