Category Archives: Federal Pedigree

Congress, Federal Pedigree

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

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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, Federal Pedigree

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

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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 →

Federal Pedigree

House Subcommittee To Markup Track & Trace Draft Today And Tomorrow

draft_partyImportant 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.I received a notice yesterday that the House of Representatives Health Subcommittee of the Energy and Commerce Committee will hold a markup session on the most recent track & trace discussion draft that was introduced there last week.  The first discussion draft was published on their website on Monday, April 22, 2013 and the second draft–the one I assume they will markup tomorrow–was published last Friday, May 3, 2013.  It appears that they may hold a vote on the draft after marking it up with any accepted amendments.

The markup sessions will be webcast for your enjoyment.  The first session will be Continue reading House Subcommittee To Markup Track & Trace Draft Today And Tomorrow →

California Board of Pharmacy, Federal Pedigree

California Responds To The Senate Pharma Track & Trace Discussion Draft

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BoP Not QuiteImportant 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.On April 26, 2013, Stanley C. Weisser, R.Ph. and President of the California Board of Pharmacy, replied to the Senate Health Education Labor and Pensions (HELP) Committee regarding their discussion draft of a potential federal pharmaceutical track & trace law that had been published one week before.  Writing on behalf of the California Board, the letter is eight pages long and includes some very detailed expressions of concern over a few specific sections of the draft.  It is well worth reading carefully.  You can ask the Board of Pharmacy for a copy, or you can see the copy I obtained here.

This is a significant document because it provides the best clues we have into how Continue reading California Responds To The Senate Pharma Track & Trace Discussion Draft →

Federal Pedigree, Sad News

The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’

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House Engergy and Commerce CommitteeLast Monday the Health Subcommittee of the House of Representatives Energy and Commerce Committee, chaired by Joe Pitts (R-PA16), published their own discussion draft of a national pharmaceutical track & trace bill and then on Thursday they held a hearing to discuss elements of it with a select group of witnesses.  The draft was sponsored by Representatives Robert Latta (R-OH5) and Jim Matheson (D-UT4).  The previous Friday the Senate Health, Education, Labor and Pensions Committee published a different discussion draft on the same topic, but held no hearing (see “The New Pharma Track & Trace Discussion Draft In The Senate”).  In my essay about the Senate version I noted that Continue reading The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’ →

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 →

Federal Pedigree

InBrief: Pharma Supply Chain Community Calls For Solutions To Security Problems

NCPO logoAt their 100th annual meeting this week, the National Conference of Pharmaceutical Organizations (NCPO) resolved that their member organizations will work together to help further secure the pharmaceutical supply chain.  The 101 year old organization is composed of major pharmaceutical industry associations from each primary segment:

American Association of Colleges of Pharmacy
American Pharmacists Association
American Society of Health-System Pharmacists
Biotechnology Industry Organization
Consumer Healthcare Products Association
Generic Pharmaceutical Association
Healthcare Distribution and Management Association
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Community Pharmacists Association
Pharmaceutical Research and Manufacturers of America

In a background document attached to a press release, the three Continue reading InBrief: Pharma Supply Chain Community Calls For Solutions To Security Problems →

Congress, Federal Pedigree

More Thoughts On The Congressional Discussion Draft

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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 →