Category Archives: Federal Pedigree

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 →

California Pedigree Law, Federal Pedigree

The California ePedigree Timeline Vs. The Senate Bill Timeline

1 Comment

CA Vs S. 957 Timeline.ZoomImportant 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.The U.S. House of Representatives passed their H.R. 1919, Safeguarding America’s Pharmaceuticals Act a few weeks ago (see, “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives” and also don’t miss “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”).  The Senate is next up with S. 957 Drug Supply Chain Security Act (or S. 959 depending on if they really did combine it with the compounding act as they passed it out of committee).

We still don’t know exactly when this bill will be debated or considered in a vote on the Senate floor but indications are that Continue reading The California ePedigree Timeline Vs. The Senate Bill Timeline →

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 →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

7 Comments

SANYO DIGITAL CAMERAImportant 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.The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”).  What is a lot-based pedigree and how is it different from one based on package-level serial numbers?  Let’s take a closer look at the kind of system that these bills would require.  Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →

Federal Pedigree

The Politics Of Federal Track & Trace Legislation

2 Comments

US CapitolWatching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational.  Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “InBrief: A Track And Trace Bill Has Made It To The House Floor” and “InBrief: A Track & Trace bill Has Made It To The Senate Floor”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.

Both of the current bills have been described as “bipartisan”.  I don’t think that’s exactly true, but before I explain why, Continue reading The Politics Of Federal Track & Trace Legislation →

Federal Pedigree

Would A U.S. Federal Pedigree Law Require A New UFA?

4 Comments

Bag-O-MoneyOne of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”.  Who pays, who gets paid, and how much?  The answer to these questions are partly determined by which technology model is in use.  One reason a distributed model is usually the first model people think of is that the funding is so obvious:  it is localized.  In that model each company would arrange for their own services.  No pooling is needed.  That’s simple to understand and quantify because everyone is in control of the services they need.

But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA? →