Tag Archives: FDA

DQSA of 2013

DQSA: How Should Transaction Data Be Exchanged?

FDALogoThe U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format.  Ironically, they will accept responses to the docket in either paper or electronic format.  Comments should be submitted to the FDA within 60 days.  If my calculation is correct, you have until April 21st to submit your comments.

This docket was expected because the Drug Supply Chain Security Act (DSCSA), enacted last November, gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of that type of information, and they are required to consult with the industry and other interested parties [see Section 582(a)(2)].  I have written about this requirement and the short time after the guidance is published before the members of the supply chain must make use of those standards (see “The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act” and “DQSA: Getting To Electronic Transaction Data Exchange“).  This docket fulfills the first of many mandates that the FDA is facing in

Continue reading DQSA: How Should Transaction Data Be Exchanged? →

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 →

Data analytics, Drug diversion

Detecting Drug Diversion With Data Analytics–An RxTrace Interview With Analytics Expert Kosta Tzavaras

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phiSystems_Logo2This week I have a special treat to share with RxTrace readers.  It is an interview I recently conducted with Kosta Tzavaras, author, publisher, leading data management expert in the pharmaceutical industry and Solutions Manager with Phi Systems in Thousand Oaks, California.  Kosta is a consultant to pharma and biotech manufacturers specializing in data analytics using supply chain and reimbursement data to help detect various kinds of drug diversion.

The original interview was conducted last summer and we updated it last week to reflect the recent passage of the Federal Drug Quality and Security Act.

Dirk:  Welcome Kosta.  Please describe your business…what it is that you do at a high level? 

Kosta:  Phi Systems is focusing in a niche area within the brand protection business in pharmaceuticals dealing with provider type of diversion, that is where healthcare providers are involved.  The two particular areas I’m focusing on are physician office diversion—diversion that is enabled by the actions of certain physicians and their practices—and the second has to do with 340B diversion or PHS (Public Health Services) account diversion.  That is diversion enabled, again, by Continue reading Detecting Drug Diversion With Data Analytics–An RxTrace Interview With Analytics Expert Kosta Tzavaras →

Combination Products

Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA

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CorrectionLast month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”).  In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e).  My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect.  Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA →

Barcodes

Will The FDA Eliminate The Linear Barcode On Drugs?

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OLYMPUS DIGITAL CAMERADuring last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”).  The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes.  This is an excellent question and I was happy the caller asked it so directly.

In her response, Dr. Bernstein pointed out that Continue reading Will The FDA Eliminate The Linear Barcode On Drugs? →

DQSA of 2013

FDA: Ready, Set, Hike!

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FDALogoTuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”).  The call was very thin on what their plan is, but that was the point.  Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike! →

Congress, Federal Pedigree

Waiting For The Senate To Act On A Track & Trace Bill, Again

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us-senate-logoThe U.S. House of Representatives made quick work of the new bipartisan, bicameral compounding and track & trace bill draft that was circulated only last Wednesday evening (see “InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”).  They interrupted their debate over defunding “ObamaCare”, the Patient Protection and Affordable Care Act (PPACA), for a quick voice vote on the newly numbered H.R. 3204, Drug Quality and Security Act (DQSA) and it passed (see the draft bill here).

So now we are waiting for the Senate to take action, just as we have for the last 3 months since the House of Representatives voted to pass their earlier bill with drug supply chain track & trace provisions, H.R. 1919, Safeguarding America’s Pharmaceuticals Act, back in June (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“ and “Still Waiting For The Senate”).  The Senate had their own Continue reading Waiting For The Senate To Act On A Track & Trace Bill, Again →

Pharma Manufacturers

Working With CMOs Under California ePedigree

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CMO ZoomImportant 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.So far in RxTrace I have explored the possible implications of the California pedigree law on drug repackagers, 3PLs, VMI relationships and, of course wholesale distributors.  Now let’s take a closer look at the murky world of the contract manufacturing organization (CMO).  I call this world “murky” only because you have to look very carefully at the relationship between a CMO and the contracting manufacturer to fully understand how the pedigree law might be applied.  And even then you are going to have to check with the California Board of Pharmacy because the law is so confusing in this area. Continue reading Working With CMOs Under California ePedigree →