FDA tightens regulations on generic drugs

The United States Food and Drug Administration (FDA) tightened regulations on generic drugs, mandating that drug-manufacturing companies inform consumers of every known health risk involved with every drug product that they sell.

The new regulations were implemented in order to close legal loopholes created by the Supreme Court involving an important distinction between brand-name and generic drugs.

In 2009, the Supreme Court ruled that if drug-manufacturing companies producing brand-name drugs didn't inform customers of all associated risks with taking the particular drug, they could be sued. However, the ruling did not include generic drugs.

Generic drugs are usually made with the same active ingredient, strength and dosage form as the brand-name drugs, and must have the same route of administration, but they don't necessarily contain all of the inactive ingredients found in the brand-name versions.

The court ruled that generic-producing drug companies are protected from lawsuits because they are not allowed to revise or update their warning labels, but since they can have the same side effects as brand-name drugs, the FDA agreed the loophole needed to be fixed.

President of the Generic Pharmaceutical Association Ralph G. Neas, like other drug company representatives, is fighting this new regulation.

"Our aim is to get the facts out there... I don't believe this [proposed] rule benefits anyone in the healthcare system," he told the Los Angeles Times.

This past November, the FDA proposed new regulations requiring generic drug makers to update their warning labels when new issues regarding the drug arise. As a result, generic drug companies will be liable for any uninformed side effects that consumers might experience. This is important because, according to the FDA, "approximately 80 percent of drugs dispensed are generic drugs."

This regulation will not be officially finalized until March. In the mean time, the FDA plans on responding to the complaints from the drug-manufacturing companies.