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.
No comments:
Post a Comment