Connecticut will receive more than $175,000 from a $13.5 million settlement against Boehringer Ingelheim Pharmaceuticals, Inc. (BI) on allegations of improper promotional and marketing practices for four of their drugs, according to a press release from the Office of the Attorney General.
The attorney generals of Kansas and Pennsylvania led the multistate investigation against BI, which concluded Dec. 20, 2017 when the company chose to settle with all 50 states and the District of Columbia. According to the complaint filed against BI, Connecticut Attorney General George Jepsen and Department of Consumer Protection Commissioner Michelle Seagull joined the lawsuit after BI violated the Connecticut Unfair Trade Practices Act, which prevents companies from misrepresenting their products.
"In the case of drug companies, the products they create and sell and the representations they make about those products, have a direct impact on the health and well-being of patients, which makes it all the more important that those representations be truthful,” Jepsen said in the press release. “Allegations of false representations about a drug's safety or effectiveness will not go unaddressed."
The drugs in question are Aggrenox, prescribed to prevent secondary strokes; Atrovent and Combivent, prescribed for treatment of COPD; and Micardis, prescribed to treat hypertension. The labeling of drugs approved by the FDA details the appropriate uses, dosages and side effects of the drug, among other criteria such as warnings or precautions for pre-existing diseases, according to the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/).
“(Drug representatives) cannot tell or suggest the side effects are overblown. They just need to stick with the product labeling,” Charles White, the head of the University of Connecticut’s Pharmacy Practice department, said in an email. “The government felt that BI was not adhering to the letter of this rule and was trying to promote uses and doses that had not been approved.”
The allegations indicated the drugs were promoted by unsubstantiated claims, such as the efficacy of Micardis in preventing strokes and heart attacks as well as treating metabolic syndrome, according to the claim filed against BI.
These unsubstantiated claims include Aggrenox’s promotion as superior to rival drug Plavix and effective in treatment of congestive heart failure and heart attacks without sufficient evidence. Additionally, BI allegedly marketed Combivent as a first line treatment for certain symptoms caused by COPD, and both Combivent and Atrovent were marketed for usage at higher doses than the label indicated. (http://www.ct.gov/ag/lib/ag/press_releases/2017/20171220_boehringeringelheim_complaintandsettlement.pdf)
"When companies misrepresent their products to consumers, not only are they acting irresponsibly, but they betray the public's trust," Seagull said in the press release. "This becomes much more serious when it affects health care products and medication.”
Additionally, the lawsuit requires BI to revise its marketing practices so as to comply with the law concerning the promotion of drugs. Allegations suggested BI was offering financial incentives for the sale of their drugs for off-label, or not explicitly labeled, uses.
“A pharmacist, nurse or doctor can let another health professional know about using the drug for off-labeled indications but the drug company representatives cannot be the ones to initiate that conversation,” White said in the email. “For instance, a doctor can call a (company’s) drug information department and ask about studies that support an off-labeled use of a drug, but the drug representatives cannot ask them to do it or alert them this information exists and suggest they check it out.”
BI said they chose to settle in order to move beyond the alleged conduct, which they say occurred in 2008, and continue the company’s mission.
“We have agreed to the settlement to avoid the costs associated with a further prolonged legal process related to these allegations,” the company said in a statement. “Resolving this matter allows us to focus our energy and resources on researching and developing innovative products to improve patients’ lives.”
Shelby Haydu is a campus correspondent for The Daily Campus. She can be reached via email at firstname.lastname@example.org.