Tag Archives: H.R. 1919

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

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 →