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

InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End

FDA Guidance AgendaMany thanks to Alec Gaffney of Regulatory Focus for pointing out that the FDA just published their annual list of draft guidances that they anticipate will be published before the end of 2013.  Of course,  no guarantees come with it.  In fact, they included the anticipation of Track & Trace guidance in last year’s list as well but nothing was published (See “FDA To Publish Track & Trace Standard By Year End“).  That’s why it’s not surprising that it’s on the list again this year.

The FDA list seems to come out earlier each year.  Considering that the Track & Trace guidance was included on last year’s list, perhaps it will be published in the near future.  I’m not holding my breath, but it sure would be an interesting addition to the current situation in California where Continue reading InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End

How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

Cumberland DistributionOn January 17, 2013 a federal grand jury indicted three individuals in 28 counts connected with Cumberland Distribution, a pharmaceutical distribution company licensed in Tennessee, on charges of conspiracy, mail fraud, money laundering and obstruction of justice.  Notably, some of the evidence used against the alleged co-conspirators are the pedigrees that they allegedly forged in an attempt to make their business look legitimate to their unsuspecting customers.

Now, as the press release about the indictment from the U.S. Department of Justice (DoJ), Middle District of Tennessee points out, “An indictment is merely an accusation and is not evidence of guilt.  All defendants are presumed innocent unless and until proven guilty in a court of law.”  So let’s just look at the evidence and how the DoJ is using it to build their case against the defendants in this case.  From that we can see what impact pedigrees might have in other cases like this.

The charges are for activities that Continue reading How Pedigrees Protect The Drug Supply: The Case Against Cumberland Distribution

How Should Inference Work?

5 Boxes
Drawing by Jasmaine Mathews

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.The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system.  Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved.  The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels.  On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.

In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code).  It leaves the important question about who Continue reading How Should Inference Work?

Celebrating Martin Luther King Jr.

Martin_Luther_King_Jr_NYWTS
Martin Luther King Jr. Thinker of powerful thoughts, and with the skill to assert them as undeniable truths.

Don’t expect to reach me today.  For the first time in my career I work for a company that celebrates Reverend Dr. Martin Luther King Jr.’s birthday as a holiday.  I am particularly happy about that, because I rank Dr. King behind only George Washington, Thomas Jefferson, and Abraham Lincoln as the greatest American Founding Father.

Neither Lincoln nor King were present at the beginning of our country so most people don’t consider them to be “Founding Fathers”, but because they both caused major course corrections in our nation’s direction that actually straightened our path and lead us to achieve freedom for all Americans, I count them that way.

The United States is among only a few nations Continue reading Celebrating Martin Luther King Jr.