US FDA professional Rx drug labels redesign "must consider the consumer"

Public Citizen's Health Research Group has presented its comments on theUS Food and Drug Administration's proposed rule to revise the format and content of professional product labeling, or package inserts, for new and recently-approved prescription drugs (Marketletters passim).

In general, the HRG says, it strongly supports the proosal, noting that for years, these labels have been difficult to read, often obscuring important information, and particularly risk information, in "a sea of black ink." However, it adds, professional labeling also needs to be improved because patients "are starved for accurate information on prescription drugs." In 1981, the drug industry, the Congress and trade groups representing pharmacists and physicians "succeeded in killing the Patient Package Insert Program," it says and, as a result, there is no consistent source of information for patients.

The FDA's Medguide program would apply to particular drugs only, it says, "if the industries do not thwart this initiative as well," while studies provided by the industry voluntarily have been shown in FDA and Public Citizen studies to lack essential safety information. Therefore, says the HRG, it is critical that the FDA consider the consumer in designing and drafting professional labeling. Many patients request the labeling from pharmacists, and more should, so it is crucial that the labeling's language is comprehensible to them.