Letters: Making generic drug labels safer

Re “The labels on generic drugs,” Editorial, March 12

The Times objects to a Food and Drug Administration proposal to allow generic drug manufacturers to update safety labeling to warn of newly discovered risks, as brand-name manufacturers have long been permitted to do. The editorial is based on the misperception that the law requires branded and generic labeling to be identical.

In fact, FDA regulations allow generic labeling to “include differences in expiration date, formulation, bioavailability, or pharmacokinetics,” among other things. Currently, generic labeling also differs from brand-name labeling for months after brand-name labeling is updated. These long-standing variations have been uncontroversial, as the FDA, Congress, manufacturers and patient advocates have long accepted that “sameness” is not to be taken literally, but functionally, as a way to implement the law’s concern that generic and brand-name drugs be equivalent.

An additional exception that applies temporarily as a means of expediting the provision of updated safety information is thus not only wise, but lawful.

Michael Carome, MD

Allison Zieve

Washington

Carome is the director of the Public Citizen Health Research Group; Zieve is the director of the Public Citizen Litigation Group.

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