Smiley & Smiley, LLP

Trying to level the drug safety playing field

The U.S. Food and Drug Administration (FDA) requires manufacturers of name-brand pharmaceuticals to thoroughly outfit their products with warnings of every possible serious side effect that may result from use of these prescription products. However, even in the face of these strict requirements, drugs can prove to be more dangerous than they were originally thought to be. Drugs like Fosamax have had to have their warning labels updated after devastating side effects have been discovered in patients.

Astonishingly, manufacturers of generic drugs are held to different standards than manufacturers of name-brand pharmaceuticals are. In an effort to ensure that patients who use generics remain just as informed as patients who use name-brand drugs, the FDA has proposed a rule that would place responsibility on generic drug makers to inform patients about all known health risks associated with their products.

According to the Los Angeles Times, the Generic Pharmaceutical Association is resisting this proposed regulation on the grounds that it would create confusion in the marketplace and raise consumer costs due to increased risk of product liability claims. According to a health economist employed at the University of California Riverside, the generic drug industry will “fight anything that could add to their costs. (But) that's why we have an FDA — to make sure consumers have enough information to make informed decisions about drugs."

However, it seems that the generic industry could simply protect itself from consumer liability claims by posting necessary warnings on its products. This effort would also likely improve patient safety by leaps and bounds. Hopefully the FDA will stand firm against the generic pharmaceutical industry’s resistance to this important proposed regulation.

Source: Los Angeles Times, “Generic drug industry needs to stand up for patient safety,” David Lazarus, Feb 27, 2014

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