GOVERNMENT and LAW

Pharmacy opposes proposal to require FDA number on labels

Pharmacy groups are resisting a Congressional effort to require a toll-free number for the Food & Drug Administration on every prescription label. The number would be for patients to report adverse drug events (ADEs).

Five pharmacy associations maintained in a letter to Congressional leaders that prescription labels already are too crowded with information required by state practice regulations. In addition, they said that the proposal represented a federal intrusion into the state regulation of pharmacy practice.

The groups also expressed concern that important auxiliary labels might not get on Rx vials because of a lack of space. "We believe that these auxiliary labels, which help to complement face-to-face counseling provided to the consumer by the pharmacist, are frankly more important to quality patient outcomes than a toll-free FDA number," the associations said.

"Pharmacists should not be put in a position of questioning their professional judgment in deciding which labels to affix in order to accommodate a mandated FDA number on the label," the groups continued. "The first goal of any prescription packaging is to assure that the consumer understands how to take [the drug] appropriately to avoid these ADE reactions."

The number on the label might lead patients to call the FDA instead of their healthcare provider, the associations said. Patients who have ADEs "should immediately call their health professional for advice and counseling, not the FDA," they stated. "We strongly believe that including this toll-free FDA number on the label will result in patient confusion, and leave the FDA bogged down with calls each day from patients about various types of issues relating to pharmaceuticals, not just ADEs."

The groups signing the letter last month were the American Pharmaceutical Association, American Society of Consultant Pharmacists, National Association of Boards of Pharmacy, National Association of Chain Drug Stores, and National Community Pharmacists Association.

Michael F. Conlan

Mike Conlan. Pharmacy opposes proposal to require FDA number on labels.

Drug Topics

2001;22:34.