E-Pedigree Vendor Selection

davidvsgoliathOn Friday after 5pm I received a call from a potential consulting client.  At least I thought that’s what they were.  It turned out, it was a headhunter looking for warm bodies to work on serialization and pedigree projects to fill a quota he has from the consulting arm of one of the big-4 accounting firms.  The people he’s looking for would probably work on projects under the direction of one of their long-term senior consultants.  I’m not looking for that kind of opportunity.

My impression is that this is a sign that we are entering the “Y2K” phase of the California E-pedigree deadlines.  That is, it is time for lots of “staff augmentation” companies to staff-up to offer “expertise” in droves. Continue reading E-Pedigree Vendor Selection

New RxTrace Column in Healthcare Packaging Magazine

HCP mag Feb13The February issue of Healthcare Packaging Magazine is out today in digital form and it contains my first contribution as Contributing Editor in my regular column called…wait for it…RxTrace!  Check it out here and let me know what you think.  Subscribers of the print magazine should receive their copy in the mail soon.  This will expose my ideas to an even wider audience and to more traditional readers.

I’d like to thank the great folks at Summit Media Group for extending the invitation and working it out.  Particular thanks go to Editor-In-Chief Jim Butschli and Publisher Jim Chrzan.  Great work guys.  It looks fabulous. Continue reading New RxTrace Column in Healthcare Packaging Magazine

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

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

The Supply Chain Provisions Of The FDA Safety & Innovation Act

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

InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again

Altuzan labeled for sale in Turkey
Altuzan labeled for sale in Turkey

Yesterday the FDA alerted healthcare providers that a cancer drug illegally imported and distributed to medical practices by a licensed pharmaceutical distributor going by the names “Medical Device King” and “Pharmalogical”, and Taranis Medical, is counterfeit.  The FDA alert can be found here.  Once again, the drug is labeled as Altuzan, a version of bevacizumab which contains the same active ingredient as Avastin.  Here is AP story about it.  Here is the WSJ article about it.

Avastin was the subject of a counterfeit importation crime about a year ago, (see “How Counterfeit Avastin Penetrated the U.S. Supply Chain“).

It is illegal to import drugs that are not approved by the FDA for sale and use in the U.S., and so even if the drug had not turned out to be a counterfeit version, this would have still been a crime.  It makes me wonder if the reason this case came to light was because the drug name on the package was clearly not approved here.  What if the counterfeit drug had been Continue reading InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again

California ePedigree Uncertainty

Pedigree law approaches CaliforniaImportant 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.A lot of things related to ePedigree in the U.S. supply chain are cooking right now but they seem to be happening a little too slowly, so it will be interesting to see where it all ends up in the next few years.  After developing the Drug Pedigree Messaging Standard (DPMS) in 2006-2007, GS1 is now taking only the initial steps toward adding network-centric ePedigree capabilities to their EPCIS and related standards.  The California Board of Pharmacy says they would like to be able to accept a semi-centralized network centric approach as long as it includes all the stuff listed in their pedigree lawFor nearly 18 months, GS1 U.S. has been “nearing publication” of a draft guideline—six years in the making—that is supposed to help companies who want to use EPCIS to meet the California law.  Congress considered passing a Federal track & trace regulation that would have preempted the California law last year but failed from lack of agreement between the parties.  Some companies are making good progress on meeting the serialization requirement but the number who have the pedigree part figured out are those who have settled on DPMS.  All the while the California pedigree deadlines are rushing toward us like a bus-sized asteroid heading straight toward Earth.  Not surprisingly, the asteroid is moving faster than the efforts to divert or absorb it.

I’ve written about my theory that the date of impact won’t be pushed out again, no matter what happens (for a full explanation of that theory, see “Will The California ePedigree Dates Slip Again?”).

What can be done?  In my view, it’s going to be determined by Continue reading California ePedigree Uncertainty

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