Monthly Archives: June 2012

Writing

Summer Writing

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A fine summer vacation!

It’s summer and for whatever reason, readership tends to go down in the summer.  People are busy with vacations and vacation planning.  After work hours and weekends are dedicated to family and outdoor fun.  That’s the way it should be.

I do have some specific essays that I want to write this summer but I intend to be a little less regular until the end of August when I will return to my weekly publishing schedule.  I may also post one or two essays this summer that are not directly related to my normal subject matter.  Call it summer recreational thinking/writing.  Watch for those and let me know what you think about them.

There are a couple of big changes coming up Continue reading Summer Writing →

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 →

Counterfeit Drugs, Reimportation

Some People Actually WANT To Buy Counterfeit Drugs

It’s hard to imagine why people would actually prefer to buy drugs from internet websites that are obviously not licensed legitimate pharmacies.  That is, those that do not require proof of a valid prescription from a legitimate prescriber, and/or do not carry an online pharmacy certification (especially from the National Association of Boards of Pharmacy, NAPB, VIIPS program).  In an earlier essay I said this about people who would buy drugs from these illegitimate sources:

“Most of the criminal activity has moved out of the legitimate supply chain, mostly onto the internet.  You know, the internet, where criminals can sell drugs directly to the few consumers who are dumb enough to think that someone will sell them legitimate prescription drugs, but do so illegally by not requiring a prescription.  That is, they think that some faceless company would be willing to knowingly break one law, but could then be trusted to provide real pharmaceuticals at below market prices.  In the age of the internet, how do you protect people who are that gullible?”

A few weeks after writing that rather disparaging passage I met one of those gullible people Continue reading Some People Actually WANT To Buy Counterfeit Drugs →

California Pedigree Law

The Preemption Provisions Built Into The California Pedigree Law

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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.In this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption.  As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017.  It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.

Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law →