The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?
The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.
First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress
One of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”. Who pays, who gets paid, and how much? The answer to these questions are partly determined by which technology model is in use. One reason a distributed model is usually the first model people think of is that the funding is so obvious: it is localized. In that model each company would arrange for their own services. No pooling is needed. That’s simple to understand and quantify because everyone is in control of the services they need.
But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA?
The Senate Health Education Labor and Pensions Committee has just voted unanimously to combine their current draft of “S. 957, Drug Supply Chain Security Act” with their current draft of “S. 959, Pharmaceutical Compounding Quality and Accountability Act” and pass the result onto the Senate floor for consideration. No amendments were offered in today’s session on either bill before the action. All committee members who spoke on behalf of both bills spoke very favorably about them. Now that the bills have been combined they will retain the number S. 959 if I understood the wording of the vote correctly.
This action, combined with the action in the House of Representatives last week (see “InBrief: A Track And Trace Bill Has Made It To The House Floor”), indicates that Continue reading InBrief: A Track & Trace bill Has Made It To The Senate Floor
On 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
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
I received a notice yesterday that the House of Representatives Health Subcommittee of the Energy and Commerce Committee will hold a markup session on the most recent track & trace discussion draft that was introduced there last week. The first discussion draft was published on their website on Monday, April 22, 2013 and the second draft–the one I assume they will markup tomorrow–was published last Friday, May 3, 2013. It appears that they may hold a vote on the draft after marking it up with any accepted amendments.
The markup sessions will be webcast for your enjoyment. The first session will be Continue reading House Subcommittee To Markup Track & Trace Draft Today And Tomorrow
On April 26, 2013, Stanley C. Weisser, R.Ph. and President of the California Board of Pharmacy, replied to the Senate Health Education Labor and Pensions (HELP) Committee regarding their discussion draft of a potential federal pharmaceutical track & trace law that had been published one week before. Writing on behalf of the California Board, the letter is eight pages long and includes some very detailed expressions of concern over a few specific sections of the draft. It is well worth reading carefully. You can ask the Board of Pharmacy for a copy, or you can see the copy I obtained here.
This is a significant document because it provides the best clues we have into how Continue reading California Responds To The Senate Pharma Track & Trace Discussion Draft