FDA'S OTC LABELING PROPOSAL IS WELCOMED

Several pharmacy organizations expressed their strong support for the Food and Drug Administration's proposals to make over-the-counter medicine labels easier to read and more inclusive of pharmacists.Among other things, the FDA wants the phrase "ask your doctor or pharmacist" to appear on OTC labels, instead of the current phrasing, which is "ask your doctor."The National Community Pharmacists Association,

Several pharmacy organizations expressed their strong support for the Food and Drug Administration's proposals to make over-the-counter medicine labels easier to read and more inclusive of pharmacists.

Among other things, the FDA wants the phrase "ask your doctor or pharmacist" to appear on OTC labels, instead of the current phrasing, which is "ask your doctor."

The National Community Pharmacists Association, based in Alexandria, Va., announced its strong support for explicit recognition of the pharmacist on the proposed labeling.

"We're pleased that the FDA is signaling its recognition of the importance of the pharmacist in ensuring proper over-the-counter medicine use by consumers," said Calvin Anthony, executive vice president of the NCPA. "It has been long-standing association policy that it is in the consumer's best interest to be directed to consult their pharmacist on the labeling of OTC products."

In its proposed rule, the FDA explained that it "recognizes that a large percentage of OTC drug products are purchased at retail stores where a pharmacist is present. Although the agency is not proposing the terms 'doctor' and 'pharmacist' as interchangeable, the agency believes the phrase 'doctor or pharmacist,' as in 'ask your doctor or pharmacist,' may be appropriate guidance on OTC drug product labeling for certain products."

The FDA's proposed rule, published last month in the Federal Register, would also include standardized labeling formats for all nonprescription drugs marketed in the United States. Essential information would be placed in the same order on all OTC medicines, with a more readable format and more understandable language.

For example, drug manufacturers would be able to use the words "throw away" instead of "discard" and "lung" instead of "pulmonary."

"We are very pleased with the thrust of the proposal and look forward to working with the agency to conclude this process with a final rule that makes OTC labels even more consumer-friendly," said James D. Cope, president of the Nonprescription Drug Manufacturers Association, Washington.

The agency will allow 120 days for public comment on the proposed rules before they go into effect. Anthony said he would encourage pharmacists and pharmacy organizations to write to the FDA during the 120-day comment period in support of adopting the "ask your doctor or pharmacist" language on all OTC product labeling.