Kefauver–Harris Amendment

The U.S. Kefauver–Harris Amendment, "Drug Efficacy Amendment," or Drug Amendments of 1962 is an amendment to the Federal Food, Drug, and Cosmetic Act.

Drug Amendments of 1962

Long title	An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes.
Nicknames	Drug Efficacy Amendment Kefauver–Harris Amendment
Enacted by	the 87th United States Congress
Effective	October 10, 1962
Citations
Public law	87-781
Statutes at Large	76 Stat. 780
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301 et seq.
Legislative history
Introduced in the Senate as S. 1552 by Estes Kefauver (D–TN) on July 19, 1962 Committee consideration by Senate Judiciary Committee Passed the Senate on August 23, 1962 (78–22) Passed the House on August 23, 1962 (passed) Reported by the joint conference committee on October 4, 1962; agreed to by the House on October 4, 1962 (347–88) and by the Senate on October 4, 1962 (passed) Signed into law by President John F. Kennedy on October 10, 1962

Background

The amendment was a response to the thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy.^[1] 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. The majority of the tragic birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States. However, samples were distributed to physicians in the US and 17 birth defects were attributed to its use.^[2] Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use.

It introduced a "proof-of-efficacy" requirement for the first time.^[3] 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.

Kefauver first gained interest in this legislation and had background knowledge in the issues in the pharmaceutical industry because he once was a member on the U.S. Senate and Antitrust Subcommittee, where his role was to oversee companies to ensure they weren't taking advantage of their consumers, for example, such as by overcharging them. During his time in the U.S. Senate and Antitrust Subcommittee, it was known that pharmaceutical companies were overpricing their drugs, produced false advertisements, and the drug industry didn't have enough regulations.

Provisions

It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,^[3][4] 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.

Previously, legislation in the Federal Food, Drug, and Cosmetic Act required the drug industry to be safe. With the Drug Amendments of 1962, a major provision was drugs had to be proven both safe and now effective before marketed for consumers.

Antibiotics required batch-by-batch testing to ensure quality and safety.^[5]

Required advertisements of drugs to include any side effects and contradictions with other drugs, and for the generic name of the drug to be included along with at least half the size of the trade name to prevent companies from overpricing their drugs.^[5]

Legislative History

Kefauver had been working for more than two years to get stronger drug regulations, but Congress had shown no interest. The major push for this legislation was the thalidomide tragedy, which major concern rose in July 1962.^[6]

These amendments were controversial where many opposed and support. For instance, some Senators opposed, such as Senator James O. Eastland because he believed that the amendments were restricting the drug industry and preventing drug manufacturers from helping Americans.^[6] Additionally, few doctors supported the amendments and hundreds of physicians had opposed the proposals of the amendments.^[7] Those who supported the bill included the public who was concerned about their safety and health, especially due to the thalidomide tragedy.

The law was signed by President John F. Kennedy on October 10, 1962.

President John F. Kennedy signs the Drug Amendments of 1962 on October 10, 1962 at the Oval Office in the White House. Those present in observing President Kennedy include Senator Thomas J. Dodd (Connecticut), Dr. Frances Oldham Kelsey, George P. Larrick, Senator Philip A. Hart (Michigan); Senator Hubert H. Humphrey (Minnesota), Senator Kefauver; Ivan A. Nestingen, Senator Olin D. Johnston (South Carolina), Representative Leo W. O'Brien (New York), and Representative Kenneth A. Roberts (Alabama).

After President John F. Kennedy signs the Drug Amendments of 1962 on October 10, 1962, he hands the pen to Senator Estes Kefauver (Tennessee).

After President John F. Kennedy signs the Drug Amendments of 1962 on October 10, 1962, he hands a pen to those observing, like Dr. Frances O. Kelsey of the Food and Drug Administration (FDA) as shown in the image.

Legislative Timeline

1. 87 H.R. 1235 Introduced in House on 1/3/1961
2. Debated in Senate on 8/22/1962
3. Debated, Amended, Passed in Senate on 8/23/1962
4. Amended, Passed House (in lieu of H.R. 11581) on 9/27/1962
5. Conference Report on 10/3/1962
6. Senate Agreed to Conference Report on 10/3/1962
7. House agreed to Conference Report on 10/4/ 1962
8. Became law on 10/10/1962^[5]

Effect

The Kefauver–Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, and Canada,^[8] 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 reactions 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.^{[citation needed]}

Louis Lasagna, then a prominent clinical pharmacologist at the Johns Hopkins School of Medicine, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment. These hearings prompted a recognition of good manufacturing practices as covering the quality of both the process and product, rather than solely the latter.^[9]

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.

See also

• Criticism of the FDA
• Directive 65/65/EEC1 (Europe)
• Drug Efficacy Study Implementation
• Durham-Humphrey Amendment
• Federal Food, Drug, and Cosmetic Act
• Frances Oldham Kelsey
• Regulation of therapeutic goods