Attorney General Bob Cooper And 44 Attorneys General Reach $105 Million Settlement With GlaxoSmithKline Concerning Asthma Drug Advair

Wednesday, June 4, 2014

Attorney General Bob Cooper announced a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers.  The 45 Attorneys General led by a bipartisan leadership committee have reached a $105 million settlement with GlaxoSmithKline, LLC to resolve allegations that GlaxoSmithKline unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin. Tennessee will receive $3 million for the Attorney General’s work on the leadership committee of this multistate consumer protection investigation.

The complaint and agreed final judgment filed today in Davidson County Circuit Court alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. In particular, the complaint alleges that GSK used false and misleading representations to promote Advair as a first line treatment for all asthma patients, including mild asthma patients who only occasionally needed a rescue inhaler. Furthermore, GSK allegedly provided financial incentives to GSK sales representatives to deceptively promote Advair for mild asthma patients.

“We appreciate the cooperative work of all the states participating in this consumer protection investigation,” Attorney General Cooper said. “My office remains vigilant in its efforts to stop deceptive marketing practices by some drug companies which may lead to unnecessary, expensive drugs and risk the health of Tennesseans.”

The agreed final judgment also requires GlaxoSmithKline to reform its marketing and promotional practices. Specifically, GSK shall not:

·         Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;

·         Make promotional claims, not approved or permitted by the FDA that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience;

·         Present favorable information or conclusions from  a study that is inadequate in design, scope  or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials;

·         Provide samples of GSK products to those health care professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled products for an off-label use; or

·         Disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry. 

The agreed final judgment also requires GSK to continue its Patient First Program at least through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the judgment requires scientifically-trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.

The State’s Complaint and Agreed Final Judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on “Filings of Interest.”

Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at 1-800-342-8385.




Street Corner Market At The Clemons Has Grand Opening Wednesday

Street Corner Market at The Clemons will host a grand opening on Wednesday at 9 a.m.   Street Corner Market at The Clemons is at 730 Chestnut St. The 2700 square foot market features fresh produce, craft beer, a deli featuring Boar’s Head Meats, locally roasted Mayfly, Rembrandt’s, and Fleetwood coffees and pastries from the Bluff View Arts District. In addition, ... (click for more)

GDOL To Help Express Employment Professionals Recruit In Lafayette

The Georgia Department of Labor (GDOL) will help Express Employment Professionals, a staffing agency, recruit at least 50 employees for two Rock Spring and one LaFayette locations. The event will be held on  Wednesday, Oct. 12 , from  9 a.m. to 12 p.m.  at the LaFayette Housing Authority located at 300 Oak Street in LaFayette. GDOL staff will be onsite to ... (click for more)

DA Pinkston Files Petition To Declare 2 Gangs A Public Nuisance

District Attorney General Neal Pinkston filed a petition on Monday asking that two Chattanooga gangs, the Gangster Disciples and the Grape Street Crips, and their members be declared public nuisances. General Pinkston is also "asking that injunctive relief be given to the law-abiding residents of East Lake by establishing a Safety Zone that covers most of their neighborhood." ... (click for more)

2 Boaters Die In Suspected Carbon Monoxide Poisoning On Chickamauga Lake

Two boaters and their pet were pronounced dead at the scene of suspected carbon monoxide poisoning on Chickamauga Lake.  Kristy D. James and Mike L. Richardson of Chattanooga were reported missing to the Hamilton County Sheriff’s Office earlier in the day by a concerned family member. The boaters had not been heard from since Saturday. Tennessee Wildlife Resources ... (click for more)

Of Course Gangs Are A Public Nuisance

Now, I don't know it all.  Beginning with my parents, folks of all sorts have been actively pointing out my ignorance for more than seven decades now.  So I'm well aware that I don't know it all.  In recent months I've begun to develop an appreciation for the local work of Mr. Neal Pinkston; I've been impressed with several things he's been doing in his official ... (click for more)

Roy Exum: Arnold Palmer’s Greatness

This is hardly meant to be flippant but I’d be willing to bet I’ve been in the presence of more great people than anyone you know. I’ve never ranked them, or ever dared to wonder who was the greatest, such as Muhammad Ali or Elvis Presley, but there are two traits that those who reach the highest pinnacle have in common. First, not a one of them was any good at what made them famous ... (click for more)