The state has ramped up efforts to crack down on pharmaceutical companies for promoting their drugs for uses not approved by the U.S. Food and Drug Administration, resulting in at least four major settlements this year.
The most recent case announced Wednesday resulted in a $42.9 million multistate settlement with drug maker Pfizer Inc. involving Hawaii and 31 other states and Washington, D.C. Hawaii’s share of the settlement was $688,105, according to the state Department of Commerce & Consumer Affairs Office of Consumer Protection.
|
CASES SETTLED
2012 Office of Consumer Protection settlements with drug manufacturers:
>> Pfizer Inc. settlement: $42.9 million (Hawaii, 31 other states and Washington, D.C.) Hawaii share: $688,105
>> Janssen Pharmaceuticals Inc. settlement: $180 million (Hawaii, 35 other states and Washington, D.C.) Hawaii share: $2.7 million
>> GlaxoSmithKline LLC settlement: $90 million (Hawaii, 36 other states and Washington, D.C.) Hawaii share: $1.3 million
>> Abbott Laboratories settlement: $100 million (Hawaii, 45 other states and Washington, D.C.) Hawaii share: $1.2 million
|
Earlier this year, Hawaii was part of multistate settlements totaling $370 million involving pharmaceutical giants Janssen Pharmaceuticals Inc., GlaxoSmithKline LLC and Abbott Laboratories for similar alleged deceptive marketing practices. Hawaii’s share of those settlements totaled $5.2 million.
"The potential for risk is so high when you’re dealing with medication and people using medication not approved by the FDA," said Bruce Kim, executive director of the state Office of Consumer Protection. "That’s why these cases are important. We’re being as vigilant as we can, given the resources we have, to try and protect Hawaii consumers from this type of conduct."
Physicians are allowed to prescribe medication for uses not approved by the FDA — or so-called off-label uses — but pharmaceutical companies are prohibited by law from promoting drugs for off-label uses, Kim said.
In the most recent case, states alleged that Pfizer made misleading and unsubstantiated claims to broaden the use of Zyvox, an antibacterial agent approved to treat certain types of infections.
The drug is approved to treat a type of pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) and related skin infections. Pfizer allegedly promoted the drug for other uses.
In addition, Pfizer allegedly used unfair and deceptive practices in promoting Lyrica, which is FDA-approved to manage pain associated with spinal cord injury.
As part of the settlement, the drug company agreed to cease promoting any Pfizer product for off-label uses.
"The real benefits of this litigation is not necessarily the monetary recovery," Kim said. "It’s the injunctive relief companies agree to in each of these settlements, prohibiting them from this conduct in the future."
