Who is Responsible for Generic Drug Safety?
In June, the US Supreme Court ruled that patients injured by generic drugs cannot successfully sue the manufacturer due to inadequate warning labels; however, the patient does have the ability to sue brand name drug makers. The Food and Drug Administration (FDA) currently does not allow generic producers to revise their product warning labels as new safety concerns are discovered. Generics are required to copy the brand-name manufacturer’s equivalent drug warning label verbatim, even if they are aware of additional risks not listed.
Public Citizen, a national nonprofit advocacy organization, has petitioned The FDA to revise regulations, allowing generic manufacturers to update their product warning labels. In 2010, over 90% of all prescriptions filled were the generic version of the desired drug. With the rise of generic use, Public Citizen believes that these manufacturers should have the ability to revise their labels to warn their consumers of all dangers, no matter when they were discovered. “The action we are requesting would bring FDA regulation in line with the realities of the pharmaceutical market and help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing,” said Allison Zieve, director of Public Citizen’s Litigation Group.
The FDA is underfunded and short staffed, previously relying on brand name drug makers to identify any potential risks. Associate Justice of the U.S. Supreme Court, Samuel Alito, stated that he believes the regulation “may significantly increase the costs for generic drug manufacturers, and therefore counteract one of the objectives of the statute, which was to provide generic drugs at a low cost.” If the petition succeeds, the FDA’s limited resources and the added responsibility of monitoring the thousands of drugs on the market will cause some serious changes in the pharmaceutical market. The Public Citizen petition asks the question, who is responsible for generic drug safety?