An Industry Protection Bill Concealed Under The Veil Of Patient Protection

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

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

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

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’

California’s Draft Regulation on Inspections

InspectorImportant 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.Tomorrow I’m going to write about last week’s hearing on “Securing Our Nation’s Prescription Drug Supply Chain” held by the U.S. House of Representatives Energy & Commerce Committee.  In the meantime, in the last few weeks I have written about the new draft regulation on certifications in California e-pedigrees and California’s Draft Regulation on Inference.  In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 6, you will find the short draft regulation on inspections.

The draft regulation on pedigree inspections is so short that I didn’t bother doing a markup with my suggestions.  Besides, I’ve written about inspecting drug pedigrees before (see “Inspecting An Electronic Pedigree“).  That essay is still valid, even though Continue reading California’s Draft Regulation on Inspections

California’s Draft Inference Regulation

Thinking cardboard boxImportant 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.Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee.  It is definitely worth watching closely, but don’t let it take your eye off of the California regulations.  Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law.  That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.

Last week I wrote about the new draft regulation on certifications in California e-pedigrees.  In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference.  This draft regulation is Continue reading California’s Draft Inference Regulation

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

Draft Regulations On Certifications Within California ePedigrees

Edited by DirkImportant 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.During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on.  The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees.  Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees

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