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 →

Congress, Federal Pedigree

An Industry Protection Bill Concealed Under The Veil Of Patient Protection

May 13, 2013 Dirk Rodgers 1 Comment

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 →

Federal Pedigree

House Subcommittee To Markup Track & Trace Draft Today And Tomorrow

May 7, 2013 Dirk Rodgers

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 →

California Board of Pharmacy, Federal Pedigree

California Responds To The Senate Pharma Track & Trace Discussion Draft

May 6, 2013 Dirk Rodgers 1 Comment

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 →

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

California’s Draft Regulation on Inspections

April 29, 2013 Dirk Rodgers

Tomorrow I’m going to write about last week’s hearing on “Securing Our Nation’s Prescription Drug Supply Chain” held by the U.S. House of Representatives Energy & Commerce Committee. In the meantime, in the last few weeks I have written about the new draft regulation on certifications in California e-pedigrees and California’s Draft Regulation on Inference. In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 6, you will find the short draft regulation on inspections.

The draft regulation on pedigree inspections is so short that I didn’t bother doing a markup with my suggestions. Besides, I’ve written about inspecting drug pedigrees before (see “Inspecting An Electronic Pedigree“). That essay is still valid, even though Continue reading California’s Draft Regulation on Inspections →

Inference

California’s Draft Inference Regulation

April 23, 2013 Dirk Rodgers

Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee. It is definitely worth watching closely, but don’t let it take your eye off of the California regulations. Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law. That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.

Last week I wrote about the new draft regulation on certifications in California e-pedigrees. In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference. This draft regulation is Continue reading California’s Draft Inference Regulation →

RxTrace

Yearly Archives: 2013