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Executive Summary

The Proprietary Assn.'s natural allies in opposition to a pharmacy-supported third class of drugs include the general merchandisers, unions and other consumer segments, President James Cope said May 13 during the assn.'s annual meeting at the Greenbrier. Characterizing the third class of drugs concept as "pharmacy monopoly," Cope asserted that "there is an awful lot of opposition to this which, if it becomes the problem it was a generation ago, today's pharmacist will find. Fifty-three thousand drug stores are hardly a match for three-quarters of a million non-drug general merchants who sell proprietary medicines. Those are the hard facts. And that doesn't even count labor unions, farm bureaus, and all the other people who have the right and who will speak up against this." Cope's comments reflect the position and rhetoric of the P-A staff on the third class of drugs issue. The subject has been getting attention among pharmacy leaders because of the Rx-to-OTC switch trend. At its annual meeting May 5-10, the American Pharmaceutical Assn. (APhA) adopted a policy position supporting the development of legislation at both the federal and state level to establish a modified third class of drugs system ("The Pink Sheet" May 14, p. 16). Under the APhA policy, "suitable legend drug products" designated for eventual non-Rx status by FDA would be available only from pharmacists for a period of five years before moving into general retail sales channels. "Refined" Third Drug Class Advocated By APhA Is Still Anticompetitive And Has Little Chance Of Success -- Cope APhA Academy of Pharmacy Practice President Dennis Smith, who explained the policy to the pharmacy group's membership, maintained that the system would "help the proprietary industry" with a "safe and effective transition." Smith claimed that the policy would "satisfy the P-A concerns" that the proposal is "another rehash of the third-class-of-drugs issue." Cope, however, declared that the third class of drugs concept "although it is refined and may be called something different, still files in the face of competitive, economic, antitrust perhaps, consumer demands, other retailers' desires, and doesn't stand much of a chance of success." While he supported the "desire on the part of our good friends the pharmacists for professional recognition," the assn.'s head declared: "Where we part company with our friends is where they would require people, by compulsion, to go to a pharmacy when they don't need to go to a pharmacist to buy something [for a problem] they can take care of themselves." P-A Chairman Charles Pergola, in his address to a general session on May 16, toned down the rhetoric of the OTC industry's opposition to a third class of drugs. Pergola looked at the issue from pharmacy's point of view and suggested that pharmacy leaders will continue to press for a third class of drugs as the Rx-to-OTC movement gains momentum. The Norcliff Thayer president, himself a pharmacist, noted that a seminar sponsored by Project Hope last March on the topic of pharmacy in the next century "one of thhe most important predictions of those in attendance . . . was that by the year 2010, almost half of all medicines used would be OTCs. The attendees also considered the perennial idea of another class of drugs, especially for newly considered Rx-to-OTC switch drugs. The majority felt that there would indeed be an additional class or classes of drugs much before the year 2010." The consensus among the pharmacy participants at the meeting, Pergola added, was that the profession "has an increasingly important role to play in the advising and dispensing of OTC medicines, and the pharmacist alone should be the dispenser of certain OTCs. The majority in this group predicted increasing pressure to continue in every possible arena -- including FDA and legislative halls, both federal and state -- to accomplish their goals." Pergola's comments came during a part of his speech on relations between the OTC industry and the pharmacy profession. "When I became chairman last May," he said, "I pledged that one of my major goals was to help pharmacy and the OTC industry get closer and to concentrate on the many areas of mutual interest instead of the minor differences. I didn't mean to imply that I can do this alone, but we have made some progress." Cope contended that the current Rx-OTC distinction among drug products "is a very hard system to try to change because it works so well." Secondly, he added, "the public has a desire and will insist upon competitive prices and convenient locations. They are not about to drive 25 miles to find an open pharmacy to buy something to take care of their headache or other health problem that they can and should and will insist upon being allowed to take care of themselves." The technical problems raised by the third class of drugs idea, Cope continued, also minimize the chances of its implementation. He asked rhetorically: Would the pharmacist be required to read the label to a purchaser of a pharmacist-legend drug at the time of sale? "Would he add something? If so, what? The label has to contain full information that the consumer needs. If he doesn't read the whole label, what does he leave off without liability?" Another problem would be monitoring "53,000 pharmacists to make sure that they are doing what the law might require, and three quarters of a million other stores to make sure they are not selling these drugs." Also, Cope maintained, the average price of a third class drug would be "about $2.50," and he asked: "How profitable is that, and would the public put up with a charge for counselling for a product which is for a condition that the public can treat themselves?" Pharmacist consulting time on Rx drugs would also be reduced, Cope said, as well as time for administration and management responsibilities.

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