Tag Archives: legitimate pharmaceutical supply chain

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

InBrief: A Track And Trace Bill Has Made It To The House Floor

A BillOn a voice vote, the Energy and Commerce Committee of the U.S. House of Representatives has just passed the recently named “H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013” on to the full House of Representatives.  One set of “technical” amendments offered by the bill’s authors was passed and four amendments offered by various Democrats were defeated prior to passage of the full bill by the committee.  This action ensures that the bill will be debated on the full House of Representatives floor at some point in the current session.  This marks the first time since 1987 that a pharmaceutical track and trace bill has made it out of a Congressional committee.

The bill that moves to the House floor has Continue reading InBrief: A Track And Trace Bill Has Made It To The House Floor

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

bird-and-fish-pattern.MCEscherImportant 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.There are two pharmaceutical track & trace bills making their way through committees of Congress, one in the U.S. House of Representatives and one in the Senate.  In both houses, these drafts are touted as bills to protect patients from the ill effects of illegitimate drugs in the legitimate supply chain, but, after reviewing the two drafts at length, I have concluded that the House draft is something else entirely.   Rather than focusing on protection of patients, the House draft is primarily intended to protect the industry from the California pedigree law.  “Patient protection” is little more than a veil to provide cover while the debate is kept on grounds more acceptable to the industry.

Here is my justification for such an assertion.  First, Continue reading An Industry Protection Bill Concealed Under The Veil Of Patient Protection

Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy

Long Beach Airport FlagsImportant 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.I finally had time to listen to the recording of the original webcast of the interview with Virginia Herold, the Executive Officer of the California Board of Pharmacy that occurred on March 20, 2013.  Shabbir Dahod of TraceLink, a supplier of ePedigree solutions and other supply chain products and services, asked a series of very detailed and very interesting questions of Ms. Herold.  The information conveyed through the questions and answers are very compelling and anyone interested in meeting the requirements of the law should listen to the whole recording.  You can get access to it here on the TraceLink website. Continue reading Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy

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

More Thoughts On The Congressional Discussion Draft

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

Congressional Legislation Development: Mad Libs Edition!

I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution SecurityAs promised last Thursday, here is my analysis.  Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.

But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs.  Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept.  The problem is Continue reading Congressional Legislation Development: Mad Libs Edition!