Part III
1962 Drug Amendments
Mass spectrometer used in an FDA laboratory Table of Contents
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Part III
1962 Drug Amendments
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Mass spectrometer used in an FDA laboratory Table of Contents
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1962 Drug Amendments
The trend toward preventive lawmaking continued. A drug tragedy in Europe, the births of thousands of deformed infants whose mothers had taken the new sedative thalidomide, focused public attention on pending U.S. legislation to further strengthen the Federal Food, Drug, and Cosmetic Act. The Drug Amendments of 1962, passed unanimously by the Congress, tightened control over prescription drugs, new drugs, and investigational drugs. It was recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established prior to marketing -- a milestone advance in medical history. Drug firms were required to send adverse reaction reports to FDA, and drug advertising in medical journals was required to provide complete information to the doctor -- the risks as well as the benefits. In the years since 1962 literally thousands of prescription drug items have been taken off the U.S. market because they lacked evidence of safety and/or effectiveness, or they have had their labeling changed to reflect the known medical facts.
Preventing harm again was the goal of amendments passed in 1976, to insure safety and effectiveness of medical devices. Federal authority to regulate therapeutic devices was first provided in the FDC Act of 1938. As a result, hundreds of quack machines and gadgets were taken off the market. The growth of medical technology, however, soon made the 1938 act obsolete in regard to legitimate devices. Spectacular growth also occurred in the related field of medical diagnostic aids. Anticipating the need for better regulation in both areas, and FDA Bureau of Medical Devices and Diagnostic Products was officially created in February 1974. Years of study and many drafts of proposed laws developed by FDA and Congressional staff workers and industry experts culminated in the Medical Device Amendments of 1976, signed by President Gerald Ford on May 28. To avoid excess regulation the new law provides for classification of devices for controls appropriate for each class. Critically important devices, such as heart pacemakers or surgical implants, must be proved safe and effective before they can be marketed.
Preventing harm is again the purpose of the newest amendment of the basic Food, Drug, and Cosmetic Act, the Infant Formula Act of 1980, drafted by Congress to insure minimum amounts of essential nutrients in commercially prepared baby foods, and to establish safety and quality standards for such foods. The Congressional action followed reports during 1979 that over 100 infants had been made seriously ill because of the lack of chlorides in two soy-based formulas. The new law authorizes FDA to adjust nutritional standards for such foods to conform with the best available scientific knowledge. Manufacturers are required to periodically test their products and report promptly to FDA when they do not meet the official specifications.
Major Trends and Developments
At the start of the 1950's the resources of FDA were seriously deficient. Appropriations and staff, never adequate, remained at approximately the levels prevailing in 1938 when Congress passed the present basic Federal Food, Drug, and Cosmetic Act, greatly increasing the Agency's responsibilities. In 1954, Commissioner Charles W. Crawford won approval by Nelson Rockefeller, undersecretary of the department, for the appointment of a representative Citizens Advisory Committee on the FDA, to study the adequacy of enforcement. The committee, adopting recommendations drafted by a distinguished industry lawyer, Charles Wesley Dunn, recommended a three-to fourfold increase in funds, to be accomplished in 5 to 10 years. The budget makers and the Congress were impressed by the committee's report, and a spectacular increase in FDA appropriations has since occurred -- from a $5 million budget in 1955 to over $320 million in 1980, with a staff increase from less than 1,000 to over 7,000.
Equally striking in the last quarter century has been the increase in FDA's scientific capability to detect and measure substances in foods, drugs, and cosmetics. FDA scientists, always outstanding for their skill in analytical chemistry, developed a new arsenal of spectrographic and chromatographic techniques, whereby contaminants can be measured in parts per billion or even per trillion. Today automated instruments can even print out the results of sample analyses in minutes, a procedure which once would have required weeks of laboratory benchwork. The increase in sensitivity of methods, by roughly one million times, revolutionized food and drug regulation. It is in this context that scientists must now decide such questions as where to draw the dividing line between consumer risk and benefits.
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Visual spectrophotometer, developed in the early 1930's by FDA chemist Paul A. Clifford and physicist Brooks Brice, was the forerunner of equipment which has increased the sensitivity of FDA analytical methods approximately a million fold -- the difference between 10 parts in a million in the 1940's and less than one part per billion today. |
| The continuing revolution in analytical techniques is typified by this high-resolution, double-focusing mass spectrometer in the FDA Washington headquarters laboratories. This advanced unit is used to identify food toxicants ranging down to one part per billion. |
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Programs Transferred
From its beginning, FDA's mission has been consumer protection. As a consequence the Agency has initiated several major consumer protection programs now administered by other agencies, and today includes consumer programs transferred to FDA from other agencies.
A great chapter in FDA history came to an end in 1968 when the FDA Bureau of Drug Abuse Control was merged with Federal narcotic law enforcement in the Department of Justice. On it own initiative FDA has pioneered in the 1940's the Federal effort to curb abuse of nonnarcotic drugs, by prosecuting dealers who sold barbiturates and amphetamines without prescriptions. The advent of the dangerous hallucinogenic drug LSD in the 1960's magnified the problem. Working with inadequate law, unarmed, and with little experience in criminal investigation, FDA inspectors went undercover as drug peddlers and secured the conviction of hundreds of racketeers and pushers. When stronger drug abuse control amendments were passed in 1965, a new FDA Bureau of Drug Abuse Control was established, with a nationwide field service and over 300 trained agents. Anticipating ultimate consolidation with the Federal Bureau of Narcotics, FDA Commissioner George Larrick planned the new bureau as a separate establishment. With the transfer, FDA lost many experienced employees, and criminal investigation became a relatively minor field of activity.
Safety of household chemical products, appliances, toys, and other consumer goods is another area of consumer protection pioneered by FDA. The Caustic Poison Act, lobbied through Congress in 1927 by Dr. Chevalier Jackson and the American Medical Association, required labels to warn parents and protect children from accidental injury and death caused by lye and 10 other caustic chemicals. In 1960 thousands of other chemical products for home use came under FDA control when the Hazardous Substances Labeling Act was passed with strong industry support. To administer this law and subsequent amendments which expanded it, FDA developed an effective consumer safety program. With the passage of the Consumer Product Safety Act, in 1972, the FDA Bureau of Product Safety became the operating organization of a new independent Consumer Product Safety Commission.
Programs Added
Important health programs were merged with FDA as a result of a 1968 departmental reorganization. By transfer from the Publish Health Service, FDA became responsible for activities to:
The health hazards of radiation have been known since the discovery of radium and the x-ray. Before World War I, FDA was taking action against quack drugs and devices claimed to be radioactive -- some of them highly dangerous. About 1913 the Public Health Services became concerned with workers who contracted cancer from luminous paint they applied to watch dials. Overdosage with diagnostic x-rays increased greatly, becoming a major public health problem. Following World War II both PHS and FDA were involved in monitoring contamination of food, milk, and public water supplies due to radioactive fallout from open testing of atomic weapons. Meanwhile, electronic technology developed a host of new products -- television, microwave ovens, lasers, etc., which could emit harmful radiation. In 1968 a comprehensive Radiation Health and Safety Act was passed, and in 1971 the product-related activities of the PHS Bureau of Radiological Health were transferred to FDA, while its environmental activities were shifted to a new Environmental Protection Administration.
One more important health program was assigned to FDA in July 1972, from the National Institutes of Health -- the regulation of biological drugs. This, the oldest continuing Federal drug control program, was begun in 1902 to insure the safety and effectiveness of vaccines, serums, antitoxins, etc., by setting standards and licensing both the producers and their products. The transfer immediately strengthened control by applying provisions of the Federal Food, Drug, and Cosmetic Act as well as the licensing controls previously in effect. More effective regulation of blood banks has been a major accomplishment of FDA's new Bureau of Biologics.
From its beginning, the law defined food and drugs as products "for man and other animals." But livestock feed and veterinary drugs were left largely to State regulation until World War I made it important to increase food production. One way was to crack down on quack veterinary medicines, especially the numerous "cures" for hog cholera. For years the Bureau of Chemistry and FDA waged war against such products, saving farmers uncounted millions in livestock losses as well as the cost of worthless drugs. Today the law for animal products closely parallels the regulation of products for humans, and FDA's Bureau of Veterinary Medicine is as much involved with the health of human consumers of animal products as it is with the animals which produce them.
The Trend Toward Prevention
There are many ways to write FDA's history. It can be a story of the laws which Congress enacted, a story of famous cases to enforce those laws, a story of the organization and the people who built it, or a story about the changing technology and the scientific controversies, some settled, others still unsolved. And it can be all of these, but not in a few pages.
If there is one dominating theme it is the change from a law that was primarily a criminal statute, protecting consumers through the deterrent effect of court proceedings to a law that is now dominantly preventive through informative regulations and premarket controls.
The premarket approval laws made important changes in FDA's methods of control. They specifically required the Agency to issue regulations explaining the requirements and procedures. The 1962 Drug Amendments called for Current Good Manufacturing Practice Regulations to set standards for plant facilities, maintenance, laboratory controls, etc., to prevent errors or accidents which could harm consumers. The idea was too good to be restricted to drugs, and in 1969 the first GMP's for food establishments were issued. All such regulations are based on actual industry practices. Today FDA inspectors especially look for GMP violations, as well as product violations.
The American public has little knowledge of the routine work of FDA, important as it is to every consumer. Much better known are its efforts to deal with newsmaking scientific problems. A succession of these, beginning with the cranberry recall of 1959, has greatly affected the Agency's work as well as its public image.
Those who read the papers or watch TV know FDA in terms of such topics as cyclamate in soft drinks, the food color Red No. 2, saccharin, nitrite, and caffeine. Chemicals and cancer are the great public health concerns of today. Much more is known about such matters than just 20 years ago, yet uncertainty about the risk of borderline carcinogens continues to hamper decisions. Generally a great deal of money is involved -- both for the users and the regulators who must seek scientifically valid answers. At the same time an inflexible law (the Delaney Clause) leaves little room for the exercise of judgment.
Fortunately, the regular business of consumer protection goes on as usual. Millions of times a day people in factories, warehouses, drugstores, and hospitals do things to comply with the food and drug law -- yet never give it a thought! Consumer protection happens because so many people do things the right way.
See also The Long Struggle for the 1906 Law.