The recent article in Fortune - “The war over Lipitor” paints a clear picture of the murky details of the Pharma industry. To sum it all up, pfizer’s Lipitor (Atorvastatin) has come to an end to its 10-year patent period. So, Ranbaxy filed an ANDA for the generic version (ahead of the other generic drug manufactures) and also won the legal battle against pfizer to gain the 6-month exclusivity to sell its generic Lipitor this November. Meanwhile, FDA accused Ranbaxy for ‘fraud’ after noticing a number of violations in their ANDA applications and their manufacturing plants and laid a ban on importing any of their 30-odd products to the US. So, Ranbaxy is currently trying to fight the battle against the FDA or more likely cut a deal (with fines) before November to take advantage of the 6-month or $700 million dollar exclusivity.
Some of the other details mentioned in the article is what makes this a more nefarious affair. Details regarding the dog-fight among generics manuafacturers -
“Getting first-to-file status has become so important that generic-drug executives have actually been known to sleep overnight in their cars in the FDA parking lot to make sure they’re the first to file the paperwork.”
Before we can get into the scandal, the question comes to mind is why would the owners sell a $1.9 billion company with generic Atorvastatin in the pipeline whose proposed sales is to be around $600 million in the first 6 months, if they didn’t know about the violations and poor standards? They sneakily sold the majority share (63%) in the company for a cool $4.6 billion to Daiichi-sankyo well before the FDA acquisitions!
The list of the violations listed by the FDA are just mind-boggling and to think that a whistle-blower was required for the FDA to notice these fraudulent schemes doesn’t paint a good picture on the FDA’s part either.
“…according to government filings (though none of the resulting allegations related to Lipitor) - Crucial tests to evaluate how quickly drugs degrade, meant to be conducted over a months-long period, were actually performed over just a few days, with the records falsified to conceal that. On certain days quality assurance supervisors who purported to be on-site were absent, and their signatures were falsified. In yet another lapse — this one potentially life-threatening — Ranbaxy risked cross-contamination of penicillin with other drug products by manufacturing them in close proximity.”
The FDA are supposedly “negotiating” these matters and not yet made a decision whether or not to let Ranbaxy manufacture and market the biggest generic drug in history of pharmaceuticals. To add fuel to this matter, Mylan Pharmaceuticals apparently filed a suit against the FDA alleging that “the FDA’s foot-dragging has hampered its efforts to plan its own generic-Lipitor launch”. Of course the FDA won this mindless lawsuit stating -
“it is under no obligation to disclose confidential deliberations or to help Mylan with its business planning.”
So then final question arises, Does this quashing of the Mylan suit indicate the FDA’s plan to allow Ranbaxy to market Atorvastatin? If yes, what would the negotiations result in? a monetary fine? corrections in their manufacturing facilities? or cancellation of Ranbaxy’s previously approved (and questionable) generic drugs? In Ranbaxy’s point of view, it all depends on the amount of fines that they face against the profits they could gain from the Atorvastatin sales.
In the end, the patients will be left with the hard choice of an over-priced Lipitor or a slightly (60-70% the price of Lipitor) cheaper generic but with no guarantee of safety for the next 6 months from November.