Wednesday, May 22, 2013

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

May 20th, 2013 | Author: Dirk Rodgers
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 readFortune Online’s new article covering the backstory that lead to the shocking May 13, 2013guilty 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 regulations requiring testing for drug quality were unnecessary and excessive and deserved to be ignored and the required test results faked.
“Executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators”, Eban writes.
This went on for years.  You really need to read the article to understand just how outrageously the company performed.
Fortunately not all of the Ranbaxy employees felt that way.  Eban documents how a small number of isolated employees heroically did the right thing and reported the abuses.  But it took nearly a decade for the U.S. FDA and the U.S. Justice Department to extract the guilty plea last week.  Citizens all over the world owe a huge debt to these brave individuals.  In this case, hero whistleblower Dinesh Thakur, a former Ranbaxy executive, will receive approximately $48.6 million from the U.S. federal share of the settlement amount, but clearly, he didn’t do it for the reward money.
I don’t know if the problem is endemic in India, but just the fact that the question can be legitimately raised after such an admission by a major Indian company is unfortunate, but no longer surprising.  The allegations of serious problems at Ranbaxy have certainly been known to regulatory agencies in the United States and India for many years.  Because the rules governing the U.S. FDA were historically designed under the assumption that all drugs sold in the U.S. were made in the U.S., the government appears to have had unfortunate difficulty investigating and acting against Ranbaxy during this time.
International crimes like those believed to have been committed in the Heparin incident in 2008and the Ranbaxy case are what led to last year’s FDA Safety and Innovation Act (FDASIA).  That law, passed last July as part of the prescription drug fee act (PDUFA), goes a long way toward converting the FDA into a regulatory agency that finally has worldwide reach for drugs that are intended for sale here.  As I read the Fortune article I kept thinking about how the FDA would have been able to act more quickly and decisively had FDASIA been in effect.
Not familiar with FDASIA?  You should be.  It is one of the most important changes to the Food, Drug and Cosmetics Act in decades.  See “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.
A recent event that came to my mind as I read Eban’s article was last November’s Global Forum on Pharmaceutical AntiCounterfeiting in Washington DC, held by Reconnaissance International.  DK Singh, Director General of Foreign Trade, Ministry of Commerce and Industry with the Indian government made some comments that stuck in my mind as just a little out of place for an event like that.  Director Singh expressed India’s commitment to safeguarding medicines.  As proof, he cited the 2011 government mandate for serialization and track & trace of all drugs exported from India.
That mandate to serialize all drugs exported from India had always struck me as more of a marketing ploy than a serious attempt to impede illegitimate drugs from entering international markets from Indian soil.  If it were a recognized problem, why wouldn’t drugs sold into the Indian domestic market by these same companies be targeted first, or even at the same time?
Mr. Singh gave us the reason.  He said that the serialization requirement was to bolster the “credibility of Indian pharma products” around the world.  He said that, in the future, serialization-based track & trace requirements would help to resolve the “false accusations” that India is a source of global substandard and falsified drugs.  He said that he wanted to attract more pharma companies to India by showing that the Indian government is “industry friendly”.
Thanks to the U.S. FDA, the U.S. Justice Department and Eban, we now know that even a large, legitimate global pharmaceutical manufacturer was knowingly and routinely shipping large quantities of substandard medicines all over the world—including substandard antimalarials to Africa (shocking quote from a Ranbaxy executive as reported by Eban:  “Who cares?  It’s just blacks dying.“).  If those drugs had serial numbers attached to them, should that make them more credible?  NO.  Especially not if you can’t even trust the manufacturer.
So I ask, does the example of Ranbaxy reveal a widespread problem in India?  We’ll see how credible the government of India is on the issue of substandard and adulterated medicines by how they react to the Ranbaxy guilty plea.  Will they react with outrage at Ranbaxy… or at the U.S. FDA?
If they care more about the safety of their own citizens, let alone people in the United States, Africa and elsewhere, than they do about resolving pre-judged “false” accusations, they will clean their own house and adopt strict monitoring, international cooperation and meaningful penalties for infractions of global companies who reside there.
The government, industry and yes, the people of India must reject this and all forms ofcorruption and reform their approach and attitudes toward product safety and quality in general, both internationally and domestically.  They must always place true “patient safety”—and not just lip service—above “industry friendly”.  Only then will the Indian pharmaceutical industry earn the type of credibility they seek in the global marketplace after this sad episode.
Finally, thank you Mr. Thakur, wherever you are.  You are an inspiration and an example for us all.
So, dear reader, what is your reaction to “Dirty Medicine”?  Leave a comment below.
quoted from RXtrace found here

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