View Full Version : Shire to pay $57.5M USD to settle investigation into marketing of ADHD meds


demuregeek
02-01-13, 09:18 PM
Sadly short on any sort of details as to what kind of dubious marketing incurred the wrath of the feds.

http://www.businessweek.com/ap/2013-02-01/shire-agrees-to-settle-adhd-drug-inquiry

Drewbacca
02-02-13, 05:19 AM
I found the following buried here (http://www.sec.gov/Archives/edgar/data/936402/000095010311001724/dp22414_10qa.htm)
Not much, but it might provide someone who isn't about to go to bed the appropriate search terms...


Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE

On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covers whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act. Shire is cooperating fully with this investigation. At this time, Shire is unable to predict the outcome or duration of this investigation.

This site (http://www.falseclaimsact.com/common_frauds_pharmaceutical.php) offers a good description of the questionable actions:


Odd Label Marketing: One common scheme by pharmaceutical manufacturers has been to market or promote their drugs to physicians for an off-label or unapproved use. Although physicians may prescribe a drug for an off-label use, pharmaceutical companies violate federal law, including the False Claims Act, when they market, promote or encourage physicians to use their drugs in an off-label or non-FDA approved manner. Pharmaceutical companies that have engaged in illegal off-label marketing or promotion of their drugs have paid the Government hundreds of millions of dollars as a result of Federal False Claims Act cases, often times brought by pharmaceutical sales representatives, sales managers, compliance officers, other pharmaceutical company employees, physicians, nurses and/or employees of hospitals or physician practices.

Other examples of possible False Claim Act violations include:
Off-Label Marketing of Drugs
Illegal Kickbacks
Inflating the Price of Pharmaceuticals
Best Price Fraud
Pharmaceutical Benefits Manager Fraud

salleh
02-02-13, 08:01 AM
I would sincerely hope that the feds are investigating the "inflating the price of pharmaceuticals" and "Best price fraud" sections of the false claim act ....

cause if that's not what they're doing .....I'll eat a bug !

demuregeek
02-02-13, 08:51 PM
Aha! Off-label marketing, possibly amongst other things. From the first link Drewbacca posted -- (some of?) Shire's SEC filings for Q1 2011:



Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE

On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covers whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act. Shire is cooperating fully with this investigation. At this time, Shire is unable to predict the outcome or duration of this investigation.


Also, from reading that filing -- zomg, do pharma companies ever engage in a whole lot of lawsuits.

Drewbacca
02-02-13, 11:14 PM
Also, from reading that filing -- zomg, do pharma companies ever engage in a whole lot of lawsuits.

Well, in fairness, that one link was a lawfirm that specialized in suing pharmaceutical companies... but I'm sure that there is no shortage of lawsuits.

demuregeek
02-03-13, 10:32 AM
Well, in fairness, that one link was a lawfirm that specialized in suing pharmaceutical companies... but I'm sure that there is no shortage of lawsuits.

It was more the legal actions section of the SEC filing -- there were, like, a dozen lawsuits where Shire was attempting to enforce or uphold its patents against drug companies who wanted to start making generic versions of something in their portfolio. It must be to the point where the drug company lawyers all know each other on a first-name basis and meet every day at the courthouse. "How many lawsuits ya got for me today, Joe?" "Six, and it's only Monday! I'm telling ya, Tracey, it's going to be a busy week."