Monthly Archives: August 2015

Deadlines

An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?

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Dear FriendDear FDA, EMA and ANVISA,

How are you?  I’m sure your summer has been busy, just like mine.  Hope you were able to get at least some time away.  I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday.  You know, the wife is not very happy about that!

The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish? →

EUDA

The ‘Unique Identifier’ in the EU Delegated Act

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The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“).  The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized.  Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018.  EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.

There are a lot of details Continue reading The ‘Unique Identifier’ in the EU Delegated Act →

Aggregation, DSCSA, wholesaler

Wholesaler Confusion Over DSCSA Aggregation Explained

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iStock_000028920134XSmallWhile listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor.  Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.

The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019.  It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA.  Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained →

Cancer, Pelotonia

Stopping Cancer

CancerDeathRatesZoomWe are making progress stopping cancer through research.  We hear about new drugs and therapies on a regular basis, but we have a long way to go.  Lung, prostate and colon-rectal cancers are the most dangerous in men, and lung, breast and colon-rectal cancers are the most dangerous for women, according to the American Cancer Society.

Fortunately, thanks to past research, most people diagnosed with cancer survive at least 5 years, although the survival stats Continue reading Stopping Cancer →

DSCSA, FDA

FDA Looking For Consulting Org To Run DSCSA Pilots

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FDALogoLast week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is: Continue reading FDA Looking For Consulting Org To Run DSCSA Pilots →

serialization

Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

RxTrace.com Serialization Estimate 2014.zoomIt’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

In each essay I produced a graph of my own personal estimate Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015 →