In the U.S., generic drugs dominate our medicine cabinets. Indeed, 80% all prescriptions written are filled with generic versions of the brand name drugs prescribed, which saves Americans more than $200 billion annually. But there are no guaranties that generics are as safe or effective as their name brand counterparts.
By law, generics are required to have the same active ingredients as name brands; they are not, however, required to have the same inactive ingredients as name brands. Although the FDA takes the position that generics are as safe and effective as name brands because they have the same active ingredients, a recent story by ABC’s Nightline illustrates how a generic drug’s different inactive ingredients can negatively impact patient health. In the story, reporters interviewed a woman whose prescription for the anti-depressant Wellbutrin XL was filled with the generic drug Budeprion XL 300. Budeprion’s different inactive ingredients caused the active ingredients to be delivered all at once rather than over an extended period of time, which made the drug both less effective and more dangerous. Ultimately, the FDA was forced to recall Budeprion XL 300 because of excessive consumer complaints.
Presently, the FDA does not require generic manufacturers to provide studies evaluating the impact of the different inactive ingredients, which is particularly troubling given that victims of defectively designed generics (unlike the victims of defectively designed name brands) cannot currently sue manufacturers for design defects or inadequate warnings following the U.S. Supreme Court’s decision in PLIVA, Inc. v. Mensing (this will hopefully change when the FDA adopts a pending administrative rule change that would correct what the Supreme Court acknowledged was the non-sensical result in the Mensing case.)
In the absence of greater FDA action and oversight, patients should ask doctors how prescriptions will be filled, and what, if any, experiences they have had with particular generics. Whenever doctors have concerns about a generic drug’s safety or efficacy, they can write “fill as prescribed” on prescriptions to require that name brands are used. However, if a physician requires a name brand when a generic is available, there is a risk that the patient’s health insurance company will refuse to cover the cost of the drug. So, until the FDA is able to ensure that generics truly are equivalent to name brands, patients will have to balance their concerns about safety with issues of cost.
Every day, we at Terrell Hogan, represent victims of personal injury and wrongful death as they seek justice, and lawsuits we have pursued have prompted safety changes. However, that came after the incidents, accidents and injuries happened. We believe it is important to try to help prevent injuries and wrongful deaths. One way is to publish information about recalls of defective and dangerous products.