Generic Drugs off the Hook for Up-To-Date Labeling

More than 70 percent of the drugs prescribed in the U.S. today are generic versions of brand-name medicines. These drugs are cheaper and considered identical to the original except for one critical component: their warning labels may be years behind reports of problems.

How is that again? According to the Food and Drug Administration, and acknowledged recently in a U.S. Supreme court ruling, generic drug makers are prohibited from updating dosing and side-effect information on labels even if they become aware of problems.

They must wait until the brand-name drug maker – who is filling fewer prescriptions and presumably seeing fewer side-effect complaints – updates its labeling information, according to FDA regulations. For some people, this might mean the difference between life, severe complications or even death.

Such was the case for two women whose lawsuits against generic drug manufacturers ended up in the U.S. Supreme Court.

The lawsuits involved the drug metoclopramide, brand-name Reglan. In one suit, Julie Demahy, claimed generic manufacturer Actavis should have warned her of the risks of developing a neurological movement disorder from the drug, prescribed for heartburn, nausea and vomiting.

In another case, Gladys Mensing sued the three generic drug makers in federal court after she developed the same disorder after taking generic versions of Reglan.

The FDA ordered that specific warnings about the disorder be added to both Reglan and metroclopramide labels in 2009, but this was years after both women began taking metroclopramide, the lawsuits claimed.

After hearing the arguments, the Supreme Court ruled that generic drug manufacturers cannot be sued for inadequate or false warning information because the FDA prohibits them from updating labeling information even if they were aware the information was inadequate. Obviously, the ruling was a big win for generic drug manufacturers, who don’t have to foot the bill for tracking adverse interactions.

This ruling in effect lets most of the drugs being prescribed these days off the hook legally for carrying the latest drug safety information.

This presents individual consumers with a damning dilemma: spring for the higher-priced brand name drugs which are under a legal obligation to report adverse effect claims to the FDA, which can then prompt alerts and updates to labeling information, or go for the generic and cross their fingers.

At the public policy level, the FDA regulation and Supreme Court ruling denies consumer access to the only system set up in this country to hold wrong-doers accountable: the judicial system.

Threat of legal action for ignoring, delaying or obscuring the results of safety tests for medical drugs motivates drug companies to provide consumers with accurate, up-to-date drug information. Take away that obligation for one major group of drug manufacturers and you eliminate a major level of accountability.

Fighting back, the national consumer group Public Citizen has petitioned the FDA to change its regulations to allow generic drug makers to update prescription labels as soon as information becomes available, and to report to the FDA when any adverse effects from their drugs comes to their attention.

Consumers have a right to be outraged that most of their prescribed drugs lack basic protections.