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May 24, 2012

Generic drug makers not being held accountable

by: Carmen S. Scott

In this light of the financial climate, savvy consumers must do a lot to ensure optimum bang for their buck—clip coupons, buy items when they go on sale and use the generic option when filling prescriptions. All these shopping traits are great for saving money in the short term. After all, every little bit helps. Or does it?

Last year, the U.S. Supreme Court ruled that a generic drug manufacturer cannot be held liable if a consumer has a negative reaction to its generic medication. This means that the medicine a patient takes must be purchased as a name brand in order for that patient’s rights to be protected. In other words, if a patient fills a generic prescription, thinking that doing so will save money, that patient gives up the right to file a suit and the right to a trial by jury if he/she experiences a serious negative reaction.

As shocking as this ruling is, the reality is that some insurance companies will not cover the cost of name brand drugs if a generic version is available. The out-of-pocket expenses for name brand drugs can be so costly that financially strapped people may choose not to take the medication or may ration out the medication rather than take it at the prescribed dosage.  Gambling with one’s health is not a choice anyone should have to make.

In April 2012, The Patient Safety and Generic Labeling Improvement Act was introduced in the Senate by Senator Patrick Leahy, with companion legislation introduced in the House of Representatives, which would address this problem. If this act passes in Congress, generic and name brand drug manufactures will be held to the same labeling standards. The Supreme Court’s original ruling was generally based on the idea that generic drug manufacturers could not control their warning label and could, therefore, not be held liable if a patient had a negative reaction. The Patient Safety and Generic Labeling Improvement Act attempts to correct this problem by permitting generic drug manufacturers the ability to change and update labels, especially as they learn of new side effects or risks. By allowing generic drug manufacturers to modify their products’ labels, the rights that currently only name brand drug users enjoy should also protect generic drug consumers.

Do you support The Patient Safety and Generic Labeling Improvement Act? Contact your Senator and ask them to push for its passing.