Tag Archives: FDA

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? →

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 →

Federal Pedigree, Sad News

The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’

April 30, 2013 Dirk Rodgers 1 Comment

Last Monday the Health Subcommittee of the House of Representatives Energy and Commerce Committee, chaired by Joe Pitts (R-PA16), published their own discussion draft of a national pharmaceutical track & trace bill and then on Thursday they held a hearing to discuss elements of it with a select group of witnesses. The draft was sponsored by Representatives Robert Latta (R-OH5) and Jim Matheson (D-UT4). The previous Friday the Senate Health, Education, Labor and Pensions Committee published a different discussion draft on the same topic, but held no hearing (see “The New Pharma Track & Trace Discussion Draft In The Senate”). In my essay about the Senate version I noted that Continue reading The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’ →

California Pedigree Law

The New Grandfathering Provisions Of The California Pedigree Law

March 4, 2013 Dirk Rodgers 1 Comment

At the February 5, 2013 meeting of the California Board of Pharmacy the Board took the final vote to proceed with filing a number of important clarifying regulations–the first since the Ridley-Thomas bill was enacted in 2008 that established the current staggered effective dates. These include the recognition of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” for use on each drug package, and definition around how supply chain companies can grandfather their existing non-serialized, non-pedigreed stock at the time the law goes into effect.

The official minutes of the meeting are not yet available but the video has been posted for a few weeks now. The pertinent action occurs in the first video of the two day meeting at approximately 2:24:00 (hours:minutes:seconds). (Don’t you just love government meetings on YouTube?) The source text of the pending regulation (which is Continue reading The New Grandfathering Provisions Of The California Pedigree Law →

Falsified Medicines

Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals

February 18, 2013 Dirk Rodgers 4 Comments

I’ve been reading the Institute of Medicine (IOM) report called “Countering the Problem of Falsified and Substandard Drugs” that was published last week. At 360 pages, it is quite literally a book, and you can buy it that way. But they also allow you to download the “Pre-publication Copy: Uncorrected Proofs” version in a 300 page PDF for free. I’m not sure why they would post uncorrected proofs rather than the final document on their site but I assume the text is in its final edited form and only the formatting might be different between the book and the PDF. I hope so anyway.

I have not yet read the whole thing so this isn’t intended to be a proper review (see the Regulatory Focus article about it). The document offers Continue reading Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals →

supply chain security

The Supply Chain Provisions Of The FDA Safety & Innovation Act

February 11, 2013 Dirk Rodgers 1 Comment

Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi

Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things. Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here). A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act →

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