Category Archives: Congress

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 →

Congress, Federal Pedigree

InBrief: A Track & Trace bill Has Made It To The Senate Floor

2 Comments

Senate HELP LogoImportant 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 Senate Health Education Labor and Pensions Committee has just voted unanimously to combine their current draft of “S. 957, Drug Supply Chain Security Act” with their current draft of “S. 959, Pharmaceutical Compounding Quality and Accountability Act” and pass the result onto the Senate floor for consideration.  No amendments were offered in today’s session on either bill before the action.  All committee members who spoke on behalf of both bills spoke very favorably about them.  Now that the bills have been combined they will retain the number S. 959 if I understood the wording of the vote correctly.

This action, combined with the action in the House of Representatives last week (see “InBrief: A Track And Trace Bill Has Made It To The House Floor”), indicates that Continue reading InBrief: A Track & Trace bill Has Made It To The Senate Floor →

Congress

InBrief: A Track And Trace Bill Has Made It To The House Floor

1 Comment

A BillOn a voice vote, the Energy and Commerce Committee of the U.S. House of Representatives has just passed the recently named “H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013” on to the full House of Representatives.  One set of “technical” amendments offered by the bill’s authors was passed and four amendments offered by various Democrats were defeated prior to passage of the full bill by the committee.  This action ensures that the bill will be debated on the full House of Representatives floor at some point in the current session.  This marks the first time since 1987 that a pharmaceutical track and trace bill has made it out of a Congressional committee.

The bill that moves to the House floor has Continue reading InBrief: A Track And Trace Bill Has Made It To The House Floor →

Congress, Federal Pedigree

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

1 Comment

bird-and-fish-pattern.MCEscherThere are two pharmaceutical track & trace bills making their way through committees of Congress, one in the U.S. House of Representatives and one in the Senate.  In both houses, these drafts are touted as bills to protect patients from the ill effects of illegitimate drugs in the legitimate supply chain, but, after reviewing the two drafts at length, I have concluded that the House draft is something else entirely.   Rather than focusing on protection of patients, the House draft is primarily intended to protect the industry from the California pedigree law.  “Patient protection” is little more than a veil to provide cover while the debate is kept on grounds more acceptable to the industry.

Here is my justification for such an assertion.  First, Continue reading An Industry Protection Bill Concealed Under The Veil Of Patient Protection →

Congress, Federal Pedigree, Uncategorized

The New Pharma Track & Trace Discussion Draft In The Senate

A discussion draftImportant 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. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation.  Take careful note of this one.  It could be the one that finally makes it.  Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate →

Congress, Federal Pedigree

More Thoughts On The Congressional Discussion Draft

1 Comment

You now have less than one week to provide a group of Congresspeople with your thoughts on their latest discussion draft for a bill that would attempt to make our U.S. drug supply chain less susceptible to criminal attacks and errors.  See my two earlier essays, “The Congressional Draft Proposal to Improve Drug Distribution Security” and “Congressional Legislation Development: Mad Libs Edition!” for more specifics.

Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is.  That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences.  I don’t know what you’ve been up to, but this is my third essay about it.  😉

There are still a few things that I wonder about. Continue reading More Thoughts On The Congressional Discussion Draft →

Congress, Federal Pedigree

Congressional Legislation Development: Mad Libs Edition!

3 Comments

I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security.  As promised last Thursday, here is my analysis.  Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.

But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs.  Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept.  The problem is Continue reading Congressional Legislation Development: Mad Libs Edition! →

Congress, Federal Pedigree

The Congressional Draft Proposal to Improve Drug Distribution Security

2 Comments

Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress.  That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee.  Download it in PDF form from Senator Harkin’s website.

I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay.  Stay tuned for that.

The email I received included the following explanation from Kathleen Laird of the HELP Committee: Continue reading The Congressional Draft Proposal to Improve Drug Distribution Security →