Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote. I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing. 😉

The text of the bill as it was before the vote appears here.

During the debate leading up to the vote, Continue reading InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives →

Congress, Federal Pedigree

InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities

June 3, 2013 Dirk Rodgers

Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).

CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”. However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.

Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

June 3, 2013 Dirk Rodgers 7 Comments

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 →

Federal Pedigree

The Politics Of Federal Track & Trace Legislation

May 29, 2013 Dirk Rodgers 2 Comments

Watching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational. Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “InBrief: A Track And Trace Bill Has Made It To The House Floor” and “InBrief: A Track & Trace bill Has Made It To The Senate Floor”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.

Both of the current bills have been described as “bipartisan”. I don’t think that’s exactly true, but before I explain why, Continue reading The Politics Of Federal Track & Trace Legislation →

Federal Pedigree

Would A U.S. Federal Pedigree Law Require A New UFA?

May 28, 2013 Dirk Rodgers 4 Comments

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? →

Congress, Federal Pedigree

InBrief: A Track & Trace bill Has Made It To The Senate Floor

May 22, 2013 Dirk Rodgers 2 Comments

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 →

Falsified Medicines

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

May 20, 2013 Dirk Rodgers 4 Comments

Americans benefit from the safest drugs and the safest drug supply chain in the world. That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world. And that is precisely why everyone in the United States should read Fortune Online’s new article covering the backstory that lead to the shocking May 13, 2013 guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud. Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.

The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide. I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products. They seemed to believe that Continue reading Ranbaxy, FDA, FDASIA and Indian Pharma Credibility →

Congress

InBrief: A Track And Trace Bill Has Made It To The House Floor

May 15, 2013 Dirk Rodgers 1 Comment

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 →

RxTrace

InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives

InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities

The Federal Lot-Based Pedigree Before Congress

The Politics Of Federal Track & Trace Legislation

Would A U.S. Federal Pedigree Law Require A New UFA?

InBrief: A Track & Trace bill Has Made It To The Senate Floor

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

InBrief: A Track And Trace Bill Has Made It To The House Floor

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance