FDA is proposing to amend its regulations to permit generic drug companies to add or strengthen safety warnings in labeling of their products on the basis of newly acquired safety information, even before the Agency has approved this safety information in the labeling of corresponding brand name drugs.
Under current rules, a generic drug must have the "same labeling" as its reference listed drug. This prevented an ANDA holder from inserting or altering a safety communication unless and until FDA has approved this information in the labeling of the brand name drug.
The purpose of the amendment is to "level the playing" field for generics, which arises from two conflicting Supreme Court decisions involving Federal preemption of safety warnings in prescription drug labeling. In Wyeth v. Levine, the Court held that a failure to warn claim in a Vermont personal injury action was not preempted by FDA labeling regulations, because the brand name drug company could have voluntarily amended its labeling to include a stronger safety warning even if FDA had not approved it. In contrast, the Court subsequently held in Pliva v. Mensing that a state failure to warn claim was preempted by FDA-approved labeling, since the generic company could not unilaterally add or strengthen its warning due to the same labeling requirement.
The proposed proposal would now allow a generic drug company to implement a new safety warning on a temporary basis, while FDA is reviewing the change for both brand name and generic drug products. The generic company would be required to notify FDA of the new warning and submit supporting data and information via a changes-being-effected ("CBE-0") supplement to its ANDA. The generic company would also have to notify the brand name company at the same time. The proposed change would be available on FDA's website. Comments may be filed by January 13, 2014.