It is time to look at the better healthcare supply chain conferences coming up this fall. This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations. For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard. After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”). That transition will likely occur over the next three years. Continue reading 2014 Fall Conference Season Preview
Dr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).
Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13
I am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking. That’s why it is so important to select the right conferences. Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones. Of course, the speakers Continue reading Fall Conference Season Preview
I’ve been doing a lot of traveling in the last few months since I left Cardinal Health. Right now my wife and I are just finishing up a visit to Culver City, CA where we arrived just in time for the birth of our first grandchild. This was a non-business trip, of course, but all of my other recent travels have been to attend conferences or public meetings of one kind or another.
One of the ways I maximize the return on investment (ROI) of attending conferences is to take lots of notes and then publish internally an analysis of the things that I thought had some important significance to my company. This technique has resulted in a searchable record of my impressions of every speaker and networking contact that struck me for any reason in almost every Continue reading How To Maximize The ROI Of Attending A Conference
I attended the Partnership for Safe Medicines (PSM) Interchange 2011 conference on October 27 in Washington DC. (I’ll cover that event more fully in a future essay.) For me, the event couldn’t have been better, but I measure events like this perhaps a little differently than most people. The agenda is important and the quality of the speakers is absolutely important, but in my view those are simply the things that lead to the one thing that can transform a merely good conference into a great conference: the quality of the attendees.
(The quality of the attendees is exactly why I like the HDMA Track and Trace Seminar. BTW, this year’s HDMA event starts this Thursday).
In the case of this year’s PSM event, I rate the quality of the attendees very high, and that’s because I had a number of great conversations with some very knowledgeable people during the breaks and at the social event the evening before. That was my interaction with the attendees, not the speakers. One of the topics of conversation surrounded the question of what exactly it was the led to the successful challenge to the Prescription Drug Marketing Act (PDMA) pedigree provisions in the RxUSA v. HHS court case and appeal and whether or not the same thing might occur with other drug pedigree laws.
AN IMPORTANT QUESTION GOES UNANSWERED
One of the first speakers at the PSM event was U.S. Representative Jim Matheson (D-UT), sponsor of H.R.3026, the “Safeguarding America’s Pharmaceuticals Act of 2011” which was introduced into the House of Representatives on September 22, 2011. There are some differences, but the core of this new bill is basically the same as Continue reading Impact of RxUSA v. HHS On Future Pedigree Legislation
Every couple of years it seems that someone introduces a bill into the U.S. Congress that would one way or another legalize the reimportation of prescription drugs into the U.S. from other countries. In December of 2009, right around the time that the Patient Protection and Affordable Care Act was being debated intensely Senator Byron Dorgan (D-ND) introduced a bill to do just that.
You may recall that there was a dustup about how Senator Barack Obama had introduced a similar bill only a few years before that, but now as President, he made a deal with the drug industry that supposedly assured that drug reimportation wouldn’t be added to the Healthcare Reform bill in exchange for the industry supporting the Reform bill. Senator Dorgan’s bill did not pass but Healthcare Reform did (See Dr. Adam Fein’s coverage of the failure of Senator Dorgan’s bill, “Drug Importation: Dead Again”).
The reason I’m thinking about reimportation this week is that I came across an interesting document that was published last week by the Partnership for Safe Medicines (PSM) called “A Risky Proposition: How Opening The U.S. To Foreign Medicines Poses A Risk To Chronically Ill Americans”, a second edition. I’m not sure why it was released now—maybe someone is thinking about introducing another reimportation bill again (I guess it’s not Senator Dorgan anyway!)—but I have an opinion about the topic Continue reading Safe Prescription Drug Reimportation: An Oxymoron