TODAY   |  November 08, 2013

Loophole could put users of generic drugs at risk

Eighty percent of the prescriptions filled in America are for generic drugs. But in the latest edition of Rossen Reports, Jeff Rossen investigates what some call a dangerous gap in the law that could put users of those generic drugs at risk.

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This content comes from Closed Captioning that was broadcast along with this program.

>> and to a story of what some are calling a safety loophole when it comes to prescription drugs . jeff rossen is here with details on this. good morning.

>> good morning. this effects all of us. a lot of us take prescription drugs and most of the time your insurance company gives you the generic. more than 80% of the time we're taking generic drugs . they're cheaper than the name brand and the fda says just as safe. what if the drug has terrible side effects and hurts you? this morning they say there's a major grap in the law putting us as risk. she has trouble eating and drinking and breathing. she twitches uncontrol bli. it all started after taking this generic drug for acid reflux.

>> i was a happy person and i liked to smile and i can't smile now. there's no smile in there.

>> reporter: she took the prescription drug for more than five years thinking it was safe.

>> the doctor told me, he said, this is going to make you better. but it didn't. it only got worse.

>> reporter: she stopped taking the drug in 2009 when the fda issued a warning that long-term use can cause the neurological disorder she has. so she tried to sue the drug makers saying the warning label for her pills was misleading and inadequate but the court dismissed her case. why? under fda rules only name brand drug makers are responsible for safety warnings. generics have to copy them. they have no control over the label. so they can't be sued.

>> if you take a brand name drug you still have your rights to go to court and hold them accountable. if you take a generic drug you have no rights and most people don't realize that.

>> reporter: not only that, some experts say it's dangerous. 84% of prescriptions are for generics. he is with the watchdog group public citizen .

>> the generic drug companies have no incentive to be vigilant to monitor for safety risk with their products.

>> because they can't be sued.

>> that's correct.

>> reporter: he says that puts us at risk and his group petitioned the fda to change the rules.

>> ultimately, we believe that generic companies need to be the ones primarily responsible for insuring the safety of their product.

>> who is it now?

>> no one is doing it adequately.

>> they told us patient safety is the foremost concern and their products are just as safe and if the rules were changed it would create unnecessary confusion and could drive up costs. in her case, the drug maker said it provided a detailed washings about the possible risk of her disorder t. same warning as the name brand . but she says that wasn't enough to protect her. her condition is irreversible and she is still unable to have her day in court.

>> i don't want anybody else to have to go through this.

>> reporter: this morning, a potentially big development in the story. the fda now says it is getting ready to change the rules to improve safety allowing generic drug makers to update their warning makers and that means open them up to liability in case patients get sick. ask your doctor questions. am i getting the name brand or the generic and ask those questions at the pharmacy as well so you know.

>> pharmacists can be a good resource as well. thank you