Tag Archives: Congress

Falsified Medicines

Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

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Studying the IOM reportI’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week.  At 360 pages, it is quite literally a book, and you can buy it that way.  But they also allow you to download the “Pre-publication Copy:  Uncorrected Proofs” version in a 300 page PDF for free.  I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF.  I hope so anyway.

I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it).  The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals →

supply chain security

The Supply Chain Provisions Of The FDA Safety & Innovation Act

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Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi
Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi

Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama.  The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things.  Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here).  A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act →

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 →

Network Centric ePedigree Models

The Significance of the Abbott, McKesson and VA Pilot

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Last month I had the opportunity to see the presentation by Abbott Labs, McKesson, the U.S. Department of Veterans Affairs (VA) and GHX about their recent and ongoing Network Centric ePedigree pilot.  [NOTE:  GS1 removed the PDF file from their website after my essay was published.  See the comments below this essay for more. – Dirk.]  I see that a presentation on the same topic is on the agenda for this week’s HDMA Track & Trace Technology Seminar.  If you are attending that event, don’t miss that presentation because this pilot is an important one.  I normally like to attend the HDMA event but I won’t be there this year due to a long-scheduled vacation.

The pilot implemented a “Centralized” Network Centric ePedigree (NCeP) system. Continue reading The Significance of the Abbott, McKesson and VA Pilot →

California Pedigree Law

Will The California ePedigree Dates Slip Again?

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Coastline near Laguna Beach California, November 2009. Photo by Dirk.
Click to enlarge image.

Important 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.Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”.  I don’t have any special or inside knowledge but, as usual, I do have a theory about that.  I offer it to you here as one possible outcome.  You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again? →

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 →

Congress, Federal Pedigree

The Congressional Draft Proposal to Improve Drug Distribution Security

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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 →

California Pedigree Law

PDUFA Will Not Include RxTEC

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Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee.  That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill.  See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates.  The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal.  The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC →