Tag Archives: Katherine Eban

DSCSA

The 2 Most Helpful Requirements In The DSCSA

There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others.  That is, they are the most helpful requirements.  Do they include serialization?  Verification?  Transaction documentation?  Wholesaler and 3PL licensing?  Not even close.

The two requirements that I believe will have the biggest impact on the safety of drugs in the US supply chain are the requirement to only engage in transactions with authorized trading partners, and the lot number being included in the 2D barcode.  Let me explain. Continue reading The 2 Most Helpful Requirements In The DSCSA →

DSCSA

DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1

iStock_000011736093SmallerAre you a pharmaceutical manufacturer who is acting as a wholesale distributor, as defined by the U.S. Drug Supply Chain Security Act (DSCSA), for some of your products?  This might occur if you are buying pre-packaged drugs from the New Drug Application (NDA)-holder or Abbreviated New Drug Application (ANDA)-holder and offering them for sale to U.S. wholesale distributors.  If you cannot justifiably fit into the DSCSA definitions of either a “co-licensed partner”, or an “exclusive distributor” for those drugs, you might as well remove them from your catalog because the “Big-3” wholesale distributors—AmerisourceBergen, Cardinal Health and McKesson—probably will not be willing to buy them anymore as of next January.

That’s because the DSCSA, which begins to take effect at that time, will most likely consider you as a Continue reading DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1 →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

SuperheroThe supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals.  It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan.  In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain.  Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development.  That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.

But will all this also lead to true protection of the supply chain from criminal activities?  Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk?  These are the true measures of the success of this type of legislation.  How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

Falsified Medicines

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

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ranbaxy_logoAmericans benefit from the safest drugs and the safest drug supply chain in the world.  That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world.  And that is precisely why everyone in the United States should read Fortune Online’s new article covering the backstory that lead to the shocking May 13, 2013 guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud.  Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.

The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide.  I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products.  They seemed to believe that Continue reading Ranbaxy, FDA, FDASIA and Indian Pharma Credibility →

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 →

PDMA

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

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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 →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice

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Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release.  He was also required to hand over $55 million, which represents the proceeds from his crimes.

What was his crime?  He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009.  In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.

This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice →

pharmaceutical supply chain

The Built-in Protections Of The U.S. Pharma Supply Chain

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Last week we learned that 11 people were charged with the record-breaking $75 Million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010 (see the excellent article by Jay Weaver in the Miami Herald, including a copy of one of the multiple indictments).  Importantly, all of the stolen drugs from the Lilly warehouse were apparently recovered before they could be re-introduced into the legitimate supply chain.  But this investigation and the charges go well beyond the infamous Lilly warehouse theft.  They include other pharmaceutical, liquor, cigarette and cell phone cargo thefts around the country, allegedly perpetrated by members of the same criminal organization.  Cracking this organization could end up disrupting the most prolific source of cargo theft in the United States over the last five years.

Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges.  They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.

This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world.  In this case, it is strong and cooperative law enforcement organizations.  While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world?  I don’t think you would (unless you’re one of the Villa brothers or their associates!).

But what are the other components that result in the safest drug supply chain in the world?  It’s certainly doesn’t occur by accident, so what are the built-in protections? Continue reading The Built-in Protections Of The U.S. Pharma Supply Chain →