The latest settlement involves a practice known as ‘off-label marketing’ in which drugmakers push medicines for uses beyond those approved by the regulator.
Connecticut and 43 other states have joined in a settlement with the British pharmaceutical firm GlaxoSmithKline (GSK) to resolve allegations of unlawful promotion of the asthma drug, Advair, and antidepressants Paxil and Wellbutrin.
State Attorney General George Jepsen alleged that GSK violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. He said the settlement will ultimately benefit consumers and bring changes to sales tactics used to motivate and compensate pharmaceutical sales teams.
GSK has agreed to pay the states $105 million to resolve the allegations. Connecticut’s share will be about $1.6 million, of which $200,000 will be split equally between the Department of Consumer Protection’s Prescription Drug Monitoring Program and the Office of Attorney General’s Consumer Fund. The remaining amount will be allocated to the state’s General Fund.
“False or misleading claims about prescription drugs can put consumers at a critical risk,” said Jepsen. “We take allegations of deceptive marketing and misrepresentation very seriously, and this sort of conduct simply will not be tolerated. Once in place, reforms included in this settlement will protect consumers from potentially deceptive practices.”
This is the second major enforcement action involving GSK in recent years. In 2012, the company was slapped with a $3 billion fine by the U.S. Justice Department after failing to report safety data on some of the company’s most popular drugs. The payment — with $1 billion going to settle criminal wrongdoing, and $2 billion to cover civil liabilities — was described as the largest fraud settlement in U.S. history, and the largest payment ever by a drug company
The latest settlement involves a practice known as “off-label marketing” in which drugmakers push medicines for uses beyond those approved by the regulator. In GSK’s case, this allegedly included promoting Advair for use by all asthma patients rather than only by the acute patients for which it was licensed. The company’s antidepressants, meanwhile, were promoted for conditions ranging from obesity to sexual dysfunction, the states said.
The consent judgment will require GSK to reform its marketing and promotional practices. Specific terms prohibit GSK from making false claims about any products and from making promotional claims that are not approved or permitted by the federal Food and Drug Administration. The agreement also prohibits GSK from disseminating information describing any off-label uses of their products, unless consistent with FDA regulations.
In addition, the settlement requires scientifically trained personnel to be responsible for developing approved responses to healthcare provider questions to ensure that such responses that are neither biased nor promotional.
Lastly, the settlement requires GSK to continue its Patient First Program through March of 2019. The mission of the Patient First Program is to reduce financial incentives for sales representatives to engage in deceptive marketing that can harm patients and consumers.
Assistant Attorneys General Thomas Saadi and Phillip Rosario, head of the Consumer Protection Department, assisted the attorney general with this matter.