Shire to Resolve Federal Investigation and Pay $57.5 Million - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Shire to Resolve Federal Investigation and Pay $57.5 Million


ePT--the Electronic Newsletter of Pharmaceutical Technology

Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company’s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana. The agreement also addresses sales and marketing practices relating to Lialda and Pentasa (both for the treatment of ulcerative colitis), pursuant to a subsequent voluntary disclosure made by Shire.

Shire has provided full cooperation to the US government throughout the process of reaching this agreement. The company will pay out $57.5 million from its fourth quarter earnings in 2012 to cover costs of the agreement and interest. The agreement is subject to change until the matter has been fully resolved. Shire and the US government are in discussions on establishing a final resolution to the investigation.

The investigation, led by the US attorney’s office for the Eastern District of Pennsylvania, was disclosed by Shire in 2009 when the company was asked for documents relating to the sales and marketing of Adderall XR, Vyvanse and Daytrana.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here