The Politics Of Federal Track & Trace Legislation

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

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

Bag-O-MoneyImportant 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.One 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?

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

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

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

ranbaxy_logoAmericans benefit from the safest drugs and the safest drug supply chain in the world.  That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world.  And that is precisely why everyone in the United States should read Fortune Online’s new article covering the backstory that lead to the shocking May 13, 2013 guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud.  Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.

The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide.  I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products.  They seemed to believe that Continue reading Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

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

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

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

bird-and-fish-pattern.MCEscherImportant 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.There 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

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 Responds To The Senate Pharma Track & Trace Discussion Draft

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