OTC Makers View FDA Label Plans

The US Nonprescription Drug Manufacturers' Association has applauded theFood and Drug Administration's proposed rule to standardize, reformat and simplify all over-the-counter drugs, but it adds that the proposed 6-point type requirement would make the rule "unworkable for a substantial number of products."

The NDMA also recommends: - a more cost-effective three-year implementation period for manufacturers, rather than the proposed two years, as there is no public health crisis with OTC drug labels requiring immediate action; - maintaining the FDA's current policy not to require the phrase "or pharmacist" to appear in OTC drug label warnings. A broader reference to any "health professional" would be more appropriate and practical than listing many different health professionals; and - a small package size exemption for OTC drug and cosmetic drug products, and exemption for cosmetic-drugs that do not bear a dosage limitation, eg sunscreens.