Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”. I don’t have any special or inside knowledge but, as usual, I do have a theory about that. I offer it to you here as one possible outcome. You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again?
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
I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security. As 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!
Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress. That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee. Download it in PDF form from Senator Harkin’s website.
I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay. Stay tuned for that.
The email I received included the following explanation from Kathleen Laird of the HELP Committee: Continue reading The Congressional Draft Proposal to Improve Drug Distribution Security
That’s right. We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it. I will explain, but first, what is a drug recall?
Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it. The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).
Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls
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
At times like these I often think of an old movie from 1981 called “Modern Problems” which starred Chevy Chase as a hapless air traffic controller who faced problem after problem, some of which wouldn’t even have existed 20 years earlier. For some reason I can’t explain, I sometimes think of that movie when I’m about to click the “Publish” button on an essay. As soon as that button is clicked, my thoughts are instantly transmitted to the world (hundreds of people in the case of RxTrace) in a neat little package.
Almost immediately after clicking the Publish button on last Friday’s essay, “IBM Divests EPCIS and ePedigree Suite” I had thoughts of another possibility that IBM’s recent action might explain. Too late. My thoughts were already being read by people. A “modern problem”. Fortunately I can send this follow-up.
Like a commenter to my Friday essay, I wondered why IBM would chuck their entire traceability repository product if the problem were simply that ePedigree only makes sense for boutique solution providers? They could have just sold off the ePedigree application and kept the more generally marketable ITS product. There has to be more to it than that. Continue reading Could It Be The Cloud? More Thoughts On IBM’s Divestiture Of Its EPCIS And E-Pedigree Suite
The IBM ITS webpage now states:
“Frequentz acquired the IBM InfoSphere Traceability Server in Oct 2, 2012. All future information regarding the InfoSphere Traceability Server products will be available from Frequentz.”
No other information about the sale was included.
This is stunning news considering the history of the ITS product, and because Continue reading IBM Divests EPCIS and ePedigree Suite