Generic Drugs Lack Regulation

What’s the Latest Development?

“In its recent decision on drug labeling, the U.S. Supreme Court prescribed a judgment that looks like bad medicine,” says Stacey Lee, a professor at the Johns Hopkins Business School. “The court ruled in Pliva v. Mensing that the Food and Drug Administration’s regulatory system pre-empts any claim in a state court that the maker of a generic drug did not adequately warn consumers of potential risks from the product.” The court ruled that “generic manufacturers cannot independently alter their warning labels without violating federal regulations.”

What’s the Big Idea?

What might a changed regulatory scheme look like? “A new framework would provide generic manufacturers direct access to the data necessary to craft adequate labeling changes. Generic makers are currently denied direct access to the clinical-trial and post-approval data that brand-name makers use in crafting product warnings. In addition, generic manufacturers have access only to adverse-event reports related to a specific generic drug. Increasing the transparency of the process could foster open communication among generic manufacturers, their branded counterparts, and the F.D.A….”