Navigation Links
Actavis Hails U.S. Supreme Court Decision in Labeling Cases
Date:6/23/2011

MORRISTOWN, N.J., June 23, 2011 /PRNewswire/ -- Actavis applauds the U.S. Supreme Court's decision in the Mensing and Demahy cases as an important step forward for consumer safety and the continued availability of affordable generic medicines.

By a 5-4 majority, the court rejected arguments that generic-drug manufacturers should be subject to state lawsuits alleging "failure to warn" over the contents of their products' labels. Justice Clarence Thomas authored the majority opinion, which concluded that federal law requiring the labels on generic products to be identical to that of their brand counterparts, and prohibiting generic manufacturers from making changes to them, preempted such cases.  

Actavis Inc. CEO Doug Boothe called the decision "an important and necessary step by the Supreme Court to clarify the proper interpretation of the regulations governing pharmaceutical labeling."

"A consistent drug-labeling standard, overseen by the federal Food and Drug Administration, as contemplated by the federal regulations is absolutely essential to protecting the safety and wellbeing of the of American consumers who rely upon generic medications for their health and quality of life," he said. "This ruling furthers meaningful consumer protection while also safeguarding against lawsuits that threaten the availability of safe and affordable pharmaceutical products by misconstruing the labeling responsibilities of generic manufacturers."

The ruling covered three separate cases that were consolidated for argument before the court in March: Actavis v. Mensing, Pliva v. Mensing and Actavis v. Demahy. The key question centered on whether consumers may sue generic drug manufacturers in state court over the contents of product labels that the companies do not control.

Boothe believes a necessary next step is for Congress to take guidance from the decision and address ambiguities in existing laws to confirm the FDA's sole authority to regulate the contents of medication labels.

"The 1980s regulatory structure that governs our industry is incompatible with the realities of the 21st century healthcare marketplace," he said. "Congress must modernize the Food, Drug and Cosmetic Act to reflect these realities, and Actavis welcomes any opportunity to work with members of Congress and the FDA to accomplish this important objective."

About Actavis Inc.

Actavis Inc. is the U.S. subsidiary of Actavis Group hf. Approximately one third of Actavis' sales are generated in North America, Actavis' single largest market. Based in Morristown, NJ, Actavis has U.S. manufacturing and packaging facilities in Elizabeth, NJ; a manufacturing facility in Lincolnton, NC; and research and development facilities in Owings Mills, MD and Sunrise, FL. Please visit www.actavis.us for more information.


'/>"/>
SOURCE Actavis
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Actavis Receives Approval of Alprazolam ODT in the U.S.
2. Actavis Launches Generic Version of Flomax(R) In The U.S.
3. Sagent Pharmaceuticals and Actavis Enter Into Exclusive U.S. Development, Supply and Marketing Collaboration for a Portfolio of Specialty Injectable Pharmaceutical Products
4. Actavis Receives Approval of Bupropion HCl SR 100mg and 200mg in the U.S.
5. Actavis Receives FDA Approval of Atomoxetine HCl Capsules
6. Actavis Receives Approval of Losartan Potassium Tablets, USP in the U.S.
7. Actavis Receives Approval of Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV in the U.S. with 180-Day Marketing Exclusivity
8. Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
9. Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h
10. Actavis Receives Approval of Pantoprazole Sodium Delayed-Release Tablets, USP in the U.S.
11. Actavis Receives Approval of Valacyclovir Hydrochloride Tablets in the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/10/2017)... , May 10, 2017 Global Health ... Latin America , published its 2017 ranking ... ranking is based on extensive data analysis from GHI,s ... largest hospitals database for the region. The GHI database covers ... , offering more than 130 data points for each institution ...
(Date:5/9/2017)...  Demonstrating its commitment to representing research- based ... Pharmaceutical Research and Manufacturers of America (PhRMA) today ... now have to meet new research and development ... join PhRMA. "By putting in place ... clear message that being a member of PhRMA ...
(Date:5/6/2017)... --  Provista , a proven leader in the supply chain ... Jim Cunniff as the company,s new president and ... to Provista, including most recently serving as the president and ... . He assumed his new role with Provista on May ... Provista," says Jody Hatcher , president, Sourcing and Collaboration ...
Breaking Medicine Technology:
(Date:5/23/2017)... City (PRWEB) , ... May 23, 2017 , ... ... Population Health and Clinical Integration company, announced today that its iClinic V12.2 ... Home (PCMH) 2017 Prevalidation. NCQA recently introduced PCMH 2017 standards which emphasize ...
(Date:5/23/2017)... NEW YORK, NY (PRWEB) , ... May 23, ... ... decision makers in the pharmaceutical and medical device sectors, today announced the winners ... • Transformers • Entrepreneurs) represent the most influential people in the healthcare industry ...
(Date:5/23/2017)... ... May 23, 2017 , ... i2i ... 2017 Best in KLAS category winner, has named Daniel P. Bullington as chief ... enhance its technology platform and product offerings,” says Justin Neece, president. “Daniel is ...
(Date:5/23/2017)... , ... May 23, 2017 , ... ... and Reconstructive Surgeon Dr. Kevin Sadati, is pleased to announce a new treatment ... collagen and elastin in their face, neck, and body through a virtually pain-free, ...
(Date:5/23/2017)... ... May 23, 2017 , ... MedTech For Solutions has announced ... laboratory, to provide hands-on training utilizing cutting-edge equipment at its recently-opened OvaTools Andrology ... MedTech Group Purchasing vendor , will provide specialized equipment to ensure OvaTools participants ...
Breaking Medicine News(10 mins):