Pharmaceutical

FDA new rule would make generic drug companies accountable for safety of their drugs

fda logo FDA new rule would make generic drug companies accountable for safety of their drugsThe Food and Drug Administration (FDA) is seeking a new rule to close a loophole that prevents manufacturers of generic drugs from adequately warning patients of potentially harmful side effects, and the public is encouraged to weigh in on the plan.

About 80 percent of all prescription drugs sold today are generic versions of brand-name drugs. Generics are required to bear the same safety labels as their branded counterparts. However, manufacturers of generic drugs cannot by law independently update their labels if the company becomes aware of new information about the drug, nor can they be held accountable if their medications injure or kill Americans if they use the same exact warnings as the brand-name drug.

The new rule would give generic drug makers the same power as brand-name manufacturers to update their drug’s label with new information. If the rule passes, both brand name and generic manufacturers would be accountable for the safety of their products. If no one is accountable, no one is safe.

The Food and Drug Administration (FDA) will take comments on the new rule for the next two months, which means all Americans can weigh in and urge the FDA to act quickly.

Take Justice Back, a website operated by the American Association for Justice in order to inform the public about civil justice issues, is urging people to let the FDA know they support these new rules for generic drug-makers by signing a petition. The petition is hosted by the website Change.org and directed to Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug Administration. Visit change.org to read and sign the petition.

Source: PharmPro