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Executive Summary

FDA's next consumer education project will be prescription drug information. Primarily a public relations effort, with no regulatory requirements planned, the effort will be designed to encourage pharmacists to provide patients with counseling at the time of dispensing and computer-generated, personalized patient information sheets. FDA Deputy Commissioner for External Affairs Carol Scheman announced the new public relations initiative in a Dec. 9 speech to the American Society of Hospital Pharmacists' mid-year clinical meeting in New Orleans. "The goal of the initiative," Scheman explained, "is to make every patient not only thoroughly familiar with the way to take the medicine, but also to make him or her aware of its risks and benefits." Scheman assured the hospital pharmacists that the program will not entail new regulations. Referring to FDA's political troubles with the mandatory Patient Package Insert program proposed during the Carter Administration, Scheman stressed: "We shall not repeat the attempt, made by the agency 12 years ago, to require pharmacists to provide patients with printed leaflets about their prescription drugs." The agency is counting on the advances in computerization and pharmacy terminals during the 1980s to make the voluntary adoption of patient information services feasible for pharmacy. Scheman pointed out that about 90% of pharmacies are "equipped with computers and printers" and that many firms have prepared software packages with drug information in lay language. FDA's interest in the new computer systems may help explain why ASHP was the forum for the initiative's announcement. While ASHP does not primarily represent retail pharmacy, it has been one of the most active groups in the field of drug information products and computerized drug information. ASHP has had a computer disk product with shortened information designed for the patient for several years. The Carter Administration's mandatory PPI program would have created an unacceptable paperwork and logistic burden for the drug distribution system, Scheman indicated. The pre-printed leaflets that would have been the heart of the program would have "required considerable storage space," Scheman observed,and would have been difficult to keep up-to-date. FDA still believes that some form of printed information on drug use and potential side effects is the most effective way to communicate with the patient. The agency describes the delivery of Rx patient information as part of its overall campaign to improve public information on FDA- regulated products. Scheman linked the patient information publicity effort to FDA's food labeling seizures, the actions against Bristol-Myers Squibb for oncology promotions and the corrective advertising agreement with Syntex on Naprosyn ads. She stated the agency's interest in patient labeling in strong language: "We at the FDA find it incomprehensible that the public's right to know should include the amount of saturated and unsaturated fat in a coffee cake -- but next to no explanation of the risks and benefits of prescription drugs." The decision to push a public relations program for patient information instead of a regulation allows FDA to maintain its general image of consumer activism without picking another fight with regulated industry. The Kessler FDA management group can maintain its consumer interest image and not add to the impression of regulatory overkill that it is creating within the regulated industries. Patient labeling is becoming a more common regulatory solution to special product problems. Upjohn, for example, recently has issued patient labeling for Halcion and is planning to add 10-day blister packaging in February or March as part of its response to the recent questions about doses and side effects from use of the benzodiazepine. FDA is asking other benzodiazepine sedative manufacturers to add the same features to their products (see related item, T&G-1). At a press briefing after Scheman's presentation, FDA pharmacy affairs chief Tom McGinnis noted that FDA will be urging companies to expand their Information for Patients section of standard labeling. "We will be working very closely with applicants that have new drugs pending," McGinnis said, "to beef up that section."

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