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THIRD CLASS OF DRUGS CITED IN NDMA BRIEFING BOOK AS A "SPECIAL PROBLEM"

This article was originally published in The Tan Sheet

Executive Summary

THIRD CLASS OF DRUGS CITED IN NDMA BRIEFING BOOK AS A "SPECIAL PROBLEM" facing the OTC drug industry. The briefing book, entitled "Self-Medication's Role in U.S. Health Care," was prepared by the Nonprescription Drug Manufacturers Association for members of the incoming Clinton Administration. The document also is being disseminated to members of the Senate Labor and Human Resources Committee and the House Energy and Commerce Committee, as well as to trade associations and health policy groups in the public and private sectors. Between 700-800 copies of the document already have been distributed, NDMA said. National uniformity in OTC drug regulation also was mentioned by the trade group as an industry problem. The briefing book criticizes the concept of a "third class of drugs" sold only by pharmacists without a prescription, reasoning that "if a drug is not safe for consumer use or if clear instructions for use cannot be written, the drug should be placed in prescription status." The book further contends that consumers "would lose a basic right to government-approved medications for self-care conveniently available at competitive prices" if the third class of drugs concept were ever adopted. Since 1915, 514 bills or regs have been introduced in the states and two in Congress to create a third class of drugs, according to NDMA. "They were all rejected," the book says, with FDA turning down a pharmacy class of OTC drugs "at least six times since 1974." Among congressional supporters of a new drug class is Rep. Ron Wyden (D-Ore.), who in the past has pushed for a third class of drugs for the OTC diet aid ingredient phenylpropanolamine. In addition, Rep. John Dingell (D-Mich.) has requested that the Office of Technology Assessment conduct a study on the feasibility and advisability of the concept. NDMA also addresses the potential role of OTCs in the current health care reform debate, noting that "self-care/self-medication is the single most cost-effective segment of the health care system." Citing a 1988 Kline & Co. study, NDMA maintained that OTCs in 1987 "saved the nation $ 10.5 bil. in health care costs -- taking into account prescription costs, doctor visits, lost time from work, insurance costs and travel." NDMA predicted that "health care cost savings from OTCs" could increase to over $ 34 bil. by the year 2000. Rx-to-OTC switches also will contribute to health care savings, the booklet says. For example, NDMA said "Americans saved more than $ 1 bil. during the first three years that one-half percent hydrocortisone" was available in OTC medications. After hydrocortisone was cleared for OTC marketing in concentrations up to 1%, NDMA noted that "savings . . . were predicted to reach $ 150 mil. during its first year of OTC sale." Switches "will increase OTC sales from $ 12 bil. today to $ 28 bil. by the year 2010," NDMA continued, with Rx-to-OTC switches having "the potential to alter drastically the competitive balance in several OTC markets" such as allergy/sinus/cold products, analgesics, antacids and antifungals.

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