Drug Safety Unscrambling Post - Approval Drug Safety Monitoring

Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between use of the drug and a safety hazard. Generic manufacturers holding Abbreviated New Drug Applications must conform their labels strictly to the pioneer label for the drug they are imitating. Pressure for the proposed change largely comes from plaintiffs’ product liability counsel and public interest groups who are concerned that the current regulatory regime permits generic manufacturers to avoid failure to warn product liability suits by invoking federal preemption so long as their labels are, as required by FDA, the same as the predicate pioneer labels. Since 90 percent by volume of drugs consumed in the United States are generic, proponents of the proposal argue that it is necessary to close a gap in compensatory relief for injured patients and enhance post-approval surveillance of adverse events. There are, however, significant reasons not to adopt the proposed rule. First, its legal validity is questionable since the Food, Drug and Cosmetic Act expressly requires generic labels to be the ‘‘same’’ as pioneer labels. Second, in a multi-seller market, enormous confusion could result if manufacturers of identical drugs had differing warnings on their labels. Thus, any introduction of a change by one generic manufacturer would require a mechanism to force all other manufacturers, including the pioneer, to conform whether or not they agreed. Third, and perhaps most important, generic manufacturers are not staffed to monitor safety and rarely are notified of adverse events because identifying which generic manufacturer’s product was dispensed by substitution to a patient whose prescription is generally for the pioneer product is difficult. Thus, without some requirement that generic manufacturers substantially, expensively and duplicatively expand their safetymonitoring capability, opening label change to them, whatever its effect on tort compensation, is unlikely to enhance drug safety. These conflicting considerations and the powerful interests behind each side of the rulemaking proposal have led, not surprisingly, to delay and inaction. But inaction is not exclusively attributable to controversy. The more fundamental problem is the absence of any clear Congressional or Agency determination about where the responsibility for ensuring post-approval drug safety should rest. The status quo, somewhat haphazBert W. Rein is a founding partner of Wiley Rein LLP. He is widely recognized as a leading food and drug, antitrust, and commercial litigator. He can be reached at brein@ wileyrein.com.