OTCS 2000: Achievements and Challenges
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0092-8615/2oo0 Copyright 0 2000 Drug Information Association Inc.
OTCS 2000: ACHIEVEMENTS AND CHALLENGES R. WILLIAMSOLLER,PHD Senior Vice President and Director of Science & Technology, Consumer Healthcare Products Association, Washington, District of Columbia
The last 30 years has brought significant changes to self care through responsible self medication. From being essentially unregulated in the 1960s, over-the-counter (OTC) medicines have been transformed by the evolving statutory and regulatory initiatives into a mature market with a high level of consumer confidence in their safety and expected benefts. This paper reviews the legislativehegulatory achievements that have modernized self care with OTCs, including the statutory and regulatory basis for OTCness, the criteria and studies used as a basis for permitting OTC availability, and the paradigm for interaction between regulators and sponsors, as well as the challenges still facing the industry. Key Words: Over-the-counter medicines; Self care
THE FOUNDATION OF OTCNESS THE LAST HALF OF this century has seen a remarkable evolution of social activism and consumer enlightenment. In the health care sector, empowering patients and consumers by educating them about health conditions and possible treatments has been driven as much by changes in technology and the positive patientkonsumer feedback on those technological improvements, as it has been on the social conscience about societal risks and the government’s response to protect the public. Indeed, American consumers have come to expect that the Food and Drug Administration (FDA) will not just protect the public health by keeping unsafe drugs off the market, but facilitate the availability of safe and effective drugs, improve the health of
Reprint address: R. William Soller, PhD, Senior Vice President and Director of Science & Technology, Consumer Healthcare Products Association, 1150 Connecticut Ave. NW, Washington, DC 20006. E-mail: wsoller @chpa-info.org.
Americans, and provide clear, easily understandable drug information for safe and effective use of prescription and OTC medicines. For OTC medicines, today’s age of self care enlightenment started with the amendments to the drug law enacted in 1962, which require that drugs be effective prior to marketing (Prior to 1962, drugs had to be proven safe, but proof of their effectiveness was not required by law). As a result, FDA was then obliged to reexamine all prescription and OTC drugs that had been approved solely on the basis of safety. For OTC drugs, the endeavor involved the review of about 730 active ingredients used in more than 3ooOOO United States drug products by 17 expert advisory panels; these panels made recommendations about their safety, effectiveness, and labeling for their intended uses. In the process, the scientifichegulatory foundation for responsible self care with OTC medicines was created and documented in the extensive public regulatory library known as the Federal Register. Today, OTCness means “ . . . the widespread availabilit
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