Generic drug mfrs should have same safety warning duty as brand name patentees - New England Journal of Medicine

On Access and Accountability - Two Supreme Court Rulings on Generic Drugs
by Marcia Boumil, J.D., LL, and Gregory Curfman, MD
New England Journal of Medicine, August 7, 2013

Generic drug manufacturers are not free to add safety warnings without FDA permission, the United States Supreme Court held in Mutual Pharmaceutical v. Bartlett. In a 5-4 decision over Sonia Sotomayor's vigorous dissent the Court dismissed the judgment in favor of a woman blinded by a drug which now carries a warning about the danger.

Tufts medical school professor Marcia Boumil and Dr. Gregory Curfman, executive editor of the New England Journal of Medicine criticize the Bartlett ruling but report that the FDA has announced a proposed rule that would "create parity" between brand-name drug patent holders and generic manufacturers.  That is the FDA plans to change its regulations to impose on generics the same duty to upgrade warnings as do new drug manufacturers still protected by patent. They write:

The Bartlett ruling, however, leaves generics  companies unaccountable to consumers — but it has apparently  prompted the FDA to consider  revising its own labeling rule.  Days after the Court’s decision,  the agency released a proposed  revision that would “create parity” in the ability of brand-name  and generic drug companies to  control their labels’ contents. If  the proposed rule is adopted, it  may increase the cost of generic  drugs, since companies will be  accountable for their labels’  contents and so will have to invest more heavily in their own  safety studies. If the Bartlett ruling stands, the cost of generic  drugs may be reduced, since  companies won’t be liable for  most of the harm caused by  their products. Since nearly four  of five prescriptions are now  filled with generic drugs, the  impact of these decisions on this  already large and growing industry can be expected to be substantial.