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U.S. Department of Health and Human Services

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Volume IV - 3.2 Historical Background and Law

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-03
VERSION NO.: 1.7

Section 3 - Drug Analysis

EFFECTIVE DATE: 10-01-03REVISED:
02-14-13

A. Introduction

The Food and Drug Act of June 30, 1906, prohibited adulteration and misbranding of drugs in interstate commerce. Following an adverse ruling (United States v. Johnson) by the Supreme Court of the United States in 1911, Congress passed the Sherley Amendment the same year, which added to the Act a prohibition against claims of curative or therapeutic effects being placed on the package label with intent to defraud the purchaser. The burden of proof of adequacy of claims, however, was on the government. Prior testing of drugs for safety was not addressed. 

In early 1938, the Wheeler-Lea Amendment to the Federal Trade Commission (FTC) Act  clarified the jurisdiction of advertising between the FTC and the FDA. The FTC reserved control of drug advertising.  The weakening of FDA authority, in conjunction with the “Elixir of Sulfanilamide” drug-related disaster, paved the way for the passage of a completely new law.

The "Elixir of Sulfanilamide" tragedy of 1937 killed 107 people due to the use of the solvent diethylene glycol in the product. Since the law did not require prior testing of drugs for safety, there was no way to anticipate, or prevent, the marketing of this lethal mixture.

The FD&C Act was passed on June 25, 1938. The new law prohibited the marketing of "new drugs," (a term  defined in the FD&C Act), unless the new drug had been tested and found to be safe for use under the prescribed conditions. The new law also required the active drug ingredient names and amounts be declared, and defined labeling be found on habit forming drugs. For false or fraudulent drug claims, the requirement that intent be demonstrated was dropped.

The Durham-Humphrey Amendment of 1951 defined the term "prescription drug"; these drugs could only be dispensed with a legal prescription. Over-the-counter (OTC) drugs were to bear labeling that contained directions for use, and warnings against misuse.

In 1962, the Thalidomide drug disaster, which demonstrated the danger of incomplete drug testing prior to clinical trials, ensured the passage of sweeping drug control legislation. Thalidomide, a sedative, taken during pregnancy, was found to cause the deformity known as phocomelia in children. The drug had never been approved for commercial sale in the United States. The use of this drug during pregnancy caused nine children in the United States to be born with this deformity.  The tragedy had much greater proportions in Europe where thalidomide had been widely distributed. 

Congress passed the Kefauver-Harris Drug Amendments on October 10, 1962, which answered the need for tighter controls over drugs. These amendments included the following changes:

  • FDA was authorized to establish current good manufacturing practices (cGMPs) for drugs.
  • Drug manufacturers were required to register annually.
  • A drug is proven to be safe and effective by the manufacturer. A new drug could no longer be marketed prior to FDA approval based on convincing evidence of the drug's safety and effectiveness.
  • Reasons were listed for which a previously approved drug could be removed from the market.
  • New controls were placed on experimental and investigational drugs.
  • Regulation of advertising of prescription drugs was returned to FDA. 

In 1972, Congress passed the Drug Listing Act, which gave FDA the means to determine readily which drugs were actually being manufactured and commercially distributed.

B.  Suggested Readings

  1. "Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration" (See Section 3.5 References 4), pp. 38-46
  2. Chapter V of the FD&C Act   (See Section 3.5 References 3)
  3. Title 21 of the Code of Federal Regulations, Parts 201, 300, 314, and 369 (See Section 3.5 References 2) Found on the Gold Disk Web CD under Regulations.
  4. Read the pertinent sections of "A Brief Legislative History of the Food, Drug, and Cosmetic Act" (See Section 3.5 References 1)
  5. Chapter 1 of Bane's "Principles of Regulatory Drug Analysis" (See Section 3.5 References 12) and Part 1 of "A Chemist's Guide to Regulatory Drug Analysis" (See Section 3.5 References 13).
  6. Compliance Policy Guidance Manual, Chapter 4, Subsection 400, Human Drugs (See Section 3.5 References 6).
  7. Official Methods of Analysis of AOAC International (current ed.). AOAC International, Gaithersburg, MD.  (See Section 3.5 Reference 10).  This is specified in Code of Federal Regulations, 21 CFR Part 2.19)