The Eyes Have It: Allergan & Off-Label Marketing
6 CommentsBy Ed Silverman // August 1st, 2011 // 10:37 am
After a follow-up visit to assess eye surgery, many patients receive a little black pouch from their opthalmologist that contains a sample med, patient information, an eye patch, some useful adhesive tape and a pair of sunglasses. These handy-dandy pouches save patients the time and confusion that may occur with finding these items after a complicated procedure where immobility may be required.
However, a whistleblower lawsuit that was filed earlier this year and recently unsealed alleges that Allergan, which sells several recuperative meds for people with serious eye problems or those who have undergone some form of surgery, improperly used these pouches to persuade docs to prescribe its drugs. The suit notes sample pouches were either provided for free or at below-market costs.
The lawsuit also alleges that Allergan promoted Acular LS, Pred Forte, Zymar and Acuvail for unapproved uses and played rough to get its way. For instance, Allergan sales reps allegedly “threatened to cease providing opthalmologists free or below-market Patient Care kits if the physician prescribed an NSAID (non-steroidal anti-inflammatory) other than Acular LS…”
This is not the first time Allergan has been caught up in accusations of illegal marketing. To settle a probe by the US Department of Justice, Allergan last fall agreed to pay $$375 million and plead guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses - headache, pain, spasticity and juvenile cerebral palsy - between 2000 and 2005. Another $225 million was paid in fines to cover civil claims asserted by the DOJ under the False Claims Act (back story).
The latest lawsuit, by the way, was brought by Caryatid, a firm that was specially organized to generate allegations of fraud that purportedly violate the False Claims Act. However, the US Department of Justice chose not to intervene, or join, the lawsuit, which was filed in January, and recently unsealed as a result (you can read the lawsuit here). We asked Allergan for a comment and will update you accordingly.
Justice in Michigan
Worth noting that this is a huge market given how many baby boomers are having, or soon will have, cataract surgery.
There have also been previous FDA warnings to Allergan for inaccurately hyping benefits of Acuvail relative to other options. On the other hand, the manufacturers of competitor drugs have been similarly chastised.
Race to the bottom in the ocular nsaid market.
original industry insider
Lose the vanity, lose the corneal refractive surgey, then lose the Acular. Save your money like I did and by a cool pair of specs. I just picked up a pair of Oliver Peoples eyeglasses similar to what Christian Bale wore as the Wall Street Banker cum serial misogynistic axe murderer in “American Psycho”. Pretty cool frames, IMHO.
company insider
THis case sunds like the feds did not join. It will be intereseting to see if they can win without the feds. THat was one of thepurposes of the False CLiams act that citizens could prosecute even when the feds were not that interested such as the Neurotin false claims act case whcih the feds joined at the last second.
Justice in Michigan
Anyone know what proportion of the rx for these drugs are for corneal refractive surgery vs. post cat. surgery?
Acuvail is being pushed heavily for the latter, competing especially with nevanac and bromday.
original industry insider
These legal issues have not seemed to hurt Allergan, judging by inventory cycles. As long as you have guys my age who are trying to look 20 years younger, either to get the job or get the chicks the sales will be strong.
http://www.fool.com/investing/general/2011/08/01/a-hidden-reason-why-the-future-looks-bright-for-a.aspx
original industry insider two
get rid of reps!