Know Your Rights: Generic Drugs

If you take a prescription drug, chances are it’s generic brand. In fact, 80% of all prescriptions in the country are generic versions. The good news is that usually these versions are cheaper than the name brand. The bad news is that patients who choose generic versions give up their right to justice.

The FDA relies on drug companies to test the safety of their drug. (The FDA does not test drugs itself.) However, if the drug company after its tests failed to warn the public about harmful or fatal side effects, patients or their families could take their case to court. Unfortunately, that is not the case if the drugs you take are generic.

In Pliva v. Mensing in 2011, a 5-4 majority of the U.S. Supreme Court ruled that generic manufacturers cannot be held accountable in court for failing to warn consumers about side effects, even if the manufacturer knew the drugs were dangerous. The company only has to label its drug with a duplicate of the brand-name equivalent’s warnings.

The Alliance for Justice described the repercussion of this situation clearly:

Here’s the problem. If the manufacturer of a brand name drug discovers new side effects after it’s on the market, the manufacturer has the right, indeed the obligation, to change the label. But generic drug manufacturers can’t change their labels until the brand name manufacturer acts. And once a drug is manufactured generically, the brand name manufacturer often leaves the market – and so is not looking for potential new side effects…

A generic drug manufacturer [can] maintain a label even if it knows that label to be inaccurate and out-of-date. In addition to raising serious safety concerns, the current regulations have had severe legal consequences for patients harmed as a result of unsafe generic drug labels…[T]he U.S. Supreme Court immunized the generic drug industry for marketing drugs with labels they know to be inaccurate and out-of-date because current regulations prevent generic companies from independently changing drug labels.

For more information, you can read the decision: [U.S. Supreme Court]

Before you choose generics, know your rights. Contact your Congressperson about supporting legislation to hold generic drug companies accountable.

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One thought on “Know Your Rights: Generic Drugs

  1. Pingback: Revisiting Generic Drugs | Fighting for Justice

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