FDA Reaches Disappointing Decision Regarding Generic Drugs
Instead of making a ruling that could have clarified a confusing situation regarding consumer rights and generic medications, the U.S. Food and Drug Administration chose to table the issue until at least 2017. As a result, people who use generics will remain unable to sue the manufacturer if they suffer complications due to taking the drugs.
Pushing it Down the Road
The FDA could have provided some clarity on this issue, possibly giving people who use generics the same right to sue as those who take name brand drugs. However, by refusing to act, the agency is simply pushing a decision farther down the road. Generic manufacturers will continue to enjoy legal protections not afforded to their name-brand counterparts. In addition, they will continue to avoid responsibility for properly warning patients about the potential risks of taking those medications.
An Odd Ruling
The confusion dates back to 2011, when the Supreme Court decided that manufacturers of generic drugs could not be held liable for failing to provide warnings to patients of potential complications. The odd reason given was that generic manufacturers have no control of the verbiage used on warning labels. There are only two ways that a generic manufacturer can alter the wording on a warning label; the original manufacturer makes changes first, or the generic manufacturer gets permission from the FDA.
Although the FDA announced in 2013 that there needed to be a level playing field when it comes to the ability to sue name brand and generic manufacturers, lobbyists acting on behalf of drug makers convinced the agency to pull back.
It simply does not make sense that people harmed by a generic version of a drug cannot sue the manufacturer, while people harmed by the name brand version of the same drug can. An estimated 80 percent of people who take prescription medications take generic versions of their drugs. As a result of the FDA’s lack of action, thousands – if not millions – of people will continue to suffer without having legal recourse.