An Early Historical Perspective on the FDA's Regulation of OTC DrugsAuthor(s): Mary K. Bruch and Elaine LarsonSource: Infection Control and Hospital Epidemiology, Vol. 10, No. 11 (Nov., 1989), pp. 527-528Published by: The University of Chicago Press on behalf of The Society for Healthcare Epidemiologyof AmericaStable URL: http://www.jstor.org/stable/30144226 .
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Readet Forum
An Early Historical Perspective on the FDA's Regulation of OTC Drugs Mary K. Bruch, MS; Elaine Larson, PhD, RN, FAAN
From a variety of contacts with hospital infection control personnel, it has become clear to us that the historical perspective about and internal workings of the Food and Drug Administration (FDA) are con- fusing and deserve clarification. The accompanying article in this issue ("Regulation of Topical Anti- microbials: History, Current Status and Future Per- spective," pp. 505-508) details the regulation of top- ical antimicrobial drugs administered by the FDA. We believe it is necessary to provide a special context for this article.
The FDA is comprised of a complicated mix of medical, technical and scientific personnel function- ing in a politically charged atmosphere. Perhaps this look back will not only provide a setting for the article, but also may change the way the actions and decisions the FDA must make are judged.
Healthcare practitioners using any product must have assurance that the product is safe and effective for its intended use, and that mechanisms for monitoring its quality are in place. This is particularly true for critical products such as drugs that are injected or ingested and devices that invade the body. Even topically applied products such as creams, lotions, cosmetics and soaps can be associated with serious toxicity. It is the mandate of the FDA to regu- late these products. To the clinician and practitioner, the structure and functions of the FDA may seem confusing, complex and either inflexibly rigid or
From Dexide, Inc., Fort Worth, Texas (Ms. Bruch) and the Johns Hopkins University School of Nursing, Baltimore, Maryland (Dr. Lar- son).
Address reprint requests to Mary K. Bruch, MS, Vice President, Dexide, Inc., P.O. Box 185789, Fort Worth, TX 76181-5789.
Bruch MK, Larson E. An early historical perspective on the FDA's regulation of OTC drugs. Infect Control Hosp Epidemiol. 1989; 10(11):527-528.
unnecessarily lax. This article reviews the history of the FDA regulation of topical antimicrobials, describes the FDA structure and operation and makes recommendations for its future direction.
HISTORY Public concern about the safety of food and drugs
can be traced to the early 1600s and to colonial English history. Society has long recognized and sought to remedy the misrepresentation of food and drug products to the consumer.' It was the fear cre- ated from contamination and adulteration of foods that finally stimulated the beginning of legislative efforts to eliminate dangerous drugs and additives to foods in the United States with the Food, Drug and Cosmetic Act (FD&C), originally passed in 1906 as the Pure Food Act. The primary legislative concern regarding foods, drugs and chemicals is to enact rules and procedures with enough interpretive leeway to assure their safety. A second concern is to also ensure that products are effective for their intended use.
At the turn of the century, conditions in the man- ufacture and distribution of food products were com- pletely unregulated and often appalling. For years there had been attempts by outside interests and leg- islators to introduce corrective legislation in Con- gress, but it took a long-delayed emotional response from the public, stimulated by Upton Sinclair's novel The Jungle, describing the excesses of the slaughter houses before the climate was conducive to passage of the 1906 law. One of the chief protagonists for pas- sage of the bill, Harvey Wiley, was assigned the imple- mentation and enforcement of the 1906 Pure Food Act. Wiley had come to Washington in 1883 and headed the Bureau of Chemistry in the Department of Agriculture, and eventually was to become the founding father of the FDA. His tenacity in pursuing the implementation of the original act was of heroic
INFECT CONTROL HOSP EPIDEMIOL 19891 Vol. 10, No. 11 527
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proportions. There was resistance to regulation by many com-
panies who were accustomed to a laissez-faire environment. Some items in the law were ahead of their time and were considered extreme by many manufacturers, while others were simply too expen- sive to implement. The 1906 Act was amended several times, often as cases were litigated. In 1927, the Bureau of Chemistry was renamed the Food, Drug and Insecticide Administration, and then shortened in 1930 to the FDA.
In the 1930s, revisions to the FD&C were intro- duced into Congress to expand the enforcement authority of the FDA and provide seizure power for dangerous drugs. Interest in this legislation was mini- mal and deliberations were lagging until a dramatic incident refocused attention on the need for a stronger enforcement authority. In 1938, about 100 persons, including many children, died after ingest- ing a new oral preparation of sulfanilimide (a so- called elixir) containing diethylene glycol (used as antifreeze) as its vehicle. This tragedy and the FDA's lack of seizure authority caught the attention of the FDA, Congress and the public, and the stalled pend- ing legislation was finally passed. This 1938 law is still the basic legal code under which the FDA functions.
In 1941 the FDA moved into the Federal Security Administration and in 1952 it -became part of the Department of Health, Education and Welfare. Today, the FDA is part of the Department of Health and Human Services with the same administrative status as the Centers for Disease Control (CDC) and the National Institutes of Health (NI H). The FDA acts under its enabling legislation, the Food, Drug and Cosmetic Act, plus others (i.e., the Radiation Control for Health and Safety Act, 1968, PL90-602). The power to make rules for the "efficient" enforcement of the Act is vested in Congress. Interpretive regula- tions originate with the FDA. The FDA has continued to influence the implementation of the 1938 Act by interpreting its provisions as a broadly-based mecha- nism permitting the promulgation of new regulations and rulemaking. In fact, the OTC regulations are an example of rulemaking raised to a fine art.
In 1958, Congress began a series of pharmaceutical industry hearings stimulated by increasing concerns and publicity about monopolistic activities, price fix- ing, lack of competition, excessive profits and the failure of generic brands of drugs to achieve a signifi- cant market share. Hearings continued for several years and many changes, in the form of amendments, were suggested and debated. In a dramatic repetition of history, the pending legislation was about to die when the thalidomide tragedy was brought to public attention in the early 1960s. Babies were born without limbs or with other severe malformations after their mothers took one of the most popular sedatives in Europe, thalidomide, during their pregnancies.
Thalidomide was then marketed by 14 firms in Europe. There were approximately 12,000 seriously deformed infants born as a result of the teratogenic
effects of thalidomide; 10,000 cases in West Germany alone. When these effects were recognized, thalidomide had been submitted to the FDA for approval, but had not been marketed in the United States because the medical reviewer within the agency, Dr. Frances Kelsey, had been suspicious about possi- ble toxicity. It is estimated that there would have been 10,000 more cases if thalidomide had been marketed in the United States. Dr. Kelsey, a physician and a toxicologist, was honored with the Presidential Medal by President Robert F. Kennedy for her work in recog- nizing the toxicity of this drug.
As a result of this incident, a pending languishing bill was revised quickly within congressional commit- tees and passed by both houses unanimously. The changes in the FD&C included in that bill are known as the Kefauver-Harris Amendments (also the 1962 Amendments). One of the major changes resulting from this legislation was the requirement that new drugs be proven to be effective as well as judged safe prior to marketing, and that substantiating data be submitted to and reviewed by the FDA prior to mar- keting. In addition, several requirements that subse- quently improved the quality of drugs and their eval- uation were included in the Kefauver-Harris Amendments: - Registration of manufacturers as drug establish-
ments; - The institution of a codified Good Manufacturing
Practice (GMP) in all drug producing plants; and - A requirement for adequate records concerning an
individual company's drug, and the right of access by FDA inspectors to obtain and examine the rec- ords of that company. The requirement for effectiveness created a prob-
lem for the FDA because numerous drugs had been approved between 1938 and 1962 without evidence of effectiveness. Because the FDA lacked the personnel to rectify this gap, it enlisted help outside the agency and authorized the National Academy of Sciences and the National Research Council (NAS/NRC) to perform an expeditious and comprehensive effec- tiveness review encompassing all these already approved, primarily prescription drugs. This evalua- tion of drugs marketed between 1938 and 1962 was called the Drug Efficacy Implementation Study (DESI), and involved 30 panels of experts. Approx- imately 4000 drugs were reviewed under DESI. When the NAS/NRC panel reviews were completed, the FDA began its active implementation of DESI. The DESI review was not completed until 1980 and the FDA made extensive attempts to eliminate ineffective drugs. The DESI review became long and complex and encumbered with continued submissions to establish effectiveness. The basic concept of the DESI review, with the use of expert review panels was used as a model for the over-the-counter (OTC) drug review of non-prescription drugs. REFERENCES 1. Janssen R. America's first food and drug laws. Food and Drug Cosmetics Law
Journal. 1975; 30:665-666.
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