Kefauver Harris Amendment
Encyclopedia
The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act
.
It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval
, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.
tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by U.S. Senator Estes Kefauver
, of Tennessee
, and U.S. Representative
Oren Harris
, of Arkansas
, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.
It introduced a "proof-of-efficacy" requirement, that was not present before. In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as new "breakthrough" medications, as they were prior to the amendment.
The law was signed by President John F. Kennedy
on October 10, 1962.
and changed the way new drugs
are approved and regulated. Before the Thalidomide scandal in Europe, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application
(NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent
was required of patients participating in clinical trials, and adverse drug reaction
s were required to be reported to the FDA.
The Drug Efficacy Study Implementation
was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
Estes Kefauver
considered the Amendment his "finest achievement" in consumer protection.
Louis Lasagna
, then a prominent clinical pharmacologist at the University of Rochester
, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
The law also exempted from the "Delaney clause
" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
.
It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval
, required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.
Background
The amendment was a response to the ThalidomideThalidomide
Thalidomide was introduced as a sedative drug in the late 1950s that was typically used to cure morning sickness. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used...
tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by U.S. Senator Estes Kefauver
Estes Kefauver
Carey Estes Kefauver July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S...
, of Tennessee
Tennessee
Tennessee is a U.S. state located in the Southeastern United States. It has a population of 6,346,105, making it the nation's 17th-largest state by population, and covers , making it the 36th-largest by total land area...
, and U.S. Representative
United States House of Representatives
The United States House of Representatives is one of the two Houses of the United States Congress, the bicameral legislature which also includes the Senate.The composition and powers of the House are established in Article One of the Constitution...
Oren Harris
Oren Harris
Oren Harris was a U.S. Representative and United States District Court Judge from Arkansas.-Background:Born in Belton, Arkansas, Harris attended public schools in Prescott, Arkansas....
, of Arkansas
Arkansas
Arkansas is a state located in the southern region of the United States. Its name is an Algonquian name of the Quapaw Indians. Arkansas shares borders with six states , and its eastern border is largely defined by the Mississippi River...
, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.
It introduced a "proof-of-efficacy" requirement, that was not present before. In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as new "breakthrough" medications, as they were prior to the amendment.
The law was signed by President John F. Kennedy
John F. Kennedy
John Fitzgerald "Jack" Kennedy , often referred to by his initials JFK, was the 35th President of the United States, serving from 1961 until his assassination in 1963....
on October 10, 1962.
Effect
The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humansHuman experimentation
Human subject research includes experiments and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, nursing, psychology, and all other social sciences. Humans have been participants in research since the earliest studies...
and changed the way new drugs
DRUGS
Destroy Rebuild Until God Shows are an American post-hardcore band formed in 2010. They released their debut self-titled album on February 22, 2011.- Formation :...
are approved and regulated. Before the Thalidomide scandal in Europe, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA) would have to show that a new drug was both safe and effective (previously the 1938 Food, Drug and Cosmetic Act was the main law that regulated drug safety). Informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
was required of patients participating in clinical trials, and adverse drug reaction
Adverse drug reaction
An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
s were required to be reported to the FDA.
The Drug Efficacy Study Implementation
Drug Efficacy Study Implementation
Drug Efficacy Study Implementation was a program begun by the Food and Drug Administration in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective,...
was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.
Estes Kefauver
Estes Kefauver
Carey Estes Kefauver July 26, 1903 – August 10, 1963) was an American politician from Tennessee. A member of the Democratic Party, he served in the U.S...
considered the Amendment his "finest achievement" in consumer protection.
Louis Lasagna
Louis Lasagna
Louis Lasagna was an American physician and professor of medicine, known for his revision of the Hippocratic Oath.-Early life and education:...
, then a prominent clinical pharmacologist at the University of Rochester
University of Rochester
The University of Rochester is a private, nonsectarian, research university in Rochester, New York, United States. The university grants undergraduate and graduate degrees, including doctoral and professional degrees. The university has six schools and various interdisciplinary programs.The...
, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
The law also exempted from the "Delaney clause
Delaney clause
The Delaney Clause is a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938, named after Congressman James Delaney of New York.It said:...
" (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.
See also
- Frances Oldham KelseyFrances Oldham KelseyFrances Kathleen Oldham Kelsey, Ph.D., M.D., is a pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that...
- Regulation of therapeutic goodsRegulation of therapeutic goodsThe regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...
- Federal Food, Drug, and Cosmetic ActFederal Food, Drug, and Cosmetic ActThe United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
- Drug Efficacy Study ImplementationDrug Efficacy Study ImplementationDrug Efficacy Study Implementation was a program begun by the Food and Drug Administration in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective,...
- Criticism of the FDA
- Directive 65/65/EEC1Directive 65/65/EEC1Directive 65/65/EEC1 was the first European pharmaceutical directive. -Intention:The directive was a reaction to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking the drug during pregnancy...
(Europe)