Consumers Beware: Incomplete Generic-Drug Warnings OK

Consumers Beware: Incomplete Generic-Drug Warnings OK

Lauren Hepler
The Columbus Dispatch
June 25, 2011

Natural SocietyExperts are warning the 75 percent of Americans who take generic prescription medication to carefully review usage and risks with pharmacists following a Supreme Court ruling this week that limits the liability of generic drugmakers.

The court ruled Thursday that since generics are copies of name-brand drugs, generic drugmakers can’t be sued for not listing risks if those risks are not on brand-name labels.

“The point here is to be critical in your questions to pharmacists and physicians prescribing the drugs,” said Ernest Boyd, executive director of the Ohio Pharmacists Association.

The case involved two Minnesota women who developed severe neurological disorders after taking the generic version of a digestive drug called Raglan. They sued the generic-drug company.

Despite evidence that the drug could cause neurological disorders if taken for longer than 12 weeks, warning labels were not changed until later on either name-brand or generic versions.

Federal law requires generic-drug manufacturers to carry the same Food and Drug Administration warnings as those on name-brand versions.

The court overruled some state laws that say generic-drug companies must update warnings if they have information about other risks.

Boyd said that, because about 50 percent of complications with prescription drugs arise from improper usage, it’s important to talk to a pharmacist about whether name-brand labels have added warnings that generics haven’t caught up with yet.

Health-care advocates say the ruling is bad news.

“This is a terrible decision for consumers,” said Cathy Levine, executive director of nonprofit advocacy group Universal Health Care Action Network of Ohio.

“Taking away the right of (generic-medication users) to sue creates a two-tier system of health care.”

She said that until this week’s decision, consumers had little incentive to purchase more expensive name-brand drugs if there was a generic version available.

“If a patient wants to switch, they’re probably going to be paying out of pocket,” said Bill Winsley, executive director of the Ohio State Board of Pharmacy.

The Generic Pharmaceutical Association says the ruling merely levels the playing field.

Before the ruling, generic drugmakers were put in the “impossible position” of defending labels made by name-brand companies, said Bob Billings, the association’s executive director.

More than 2.6 billion prescriptions were written in 2008, according to the most recent statistics from the Centers for Disease Control and Prevention.

“The Supreme Court handed a windfall to one of the most powerful and wealthy industries in the country,” Levine said.

She said consumers also should be aware of a second ruling Thursday that allows pharmaceutical companies to enhance marketing efforts by purchasing lists of the medications prescribed by individual doctors.

Winsley said rules for “data-mining” still protect the privacy of patients but reveal what drugs doctors are prescribing.

“The decision on data-mining is an even worse blow for consumers,” Levine said.

She said the new rule could present a conflict of interest for doctors who must weigh the best interest of patients against financial pressure from drugmakers.