**A History of the FDA and Drug Regulation in the United States**

**For a more detailed history, please visit the FDA centennial website
at <http://www.fda.gov/centennial/history/history.html>**

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**[1820]{.underline}**

> Eleven doctors set up the U.S. Pharmacopeia and record the first list
> of standard drugs.

**[1848]{.underline}**

> **Drug Importation Act** passed by Congress requires U.S. Customs
> Service inspection to stop entry of tainted, low quality drugs from
> overseas.

**[1883]{.underline}**

> Dr. Harvey W. Wiley becomes the chief chemist at the Bureau of
> Chemistry's food adulteration studies.

**[1905]{.underline}**

> The American Medical Association (AMA) begins a voluntary program of
> drug approval that would last until 1955. In order to advertise in the
> AMA and related journals, drug companies must show proof that the drug
> will treat what they claim.

**[1906]{.underline}**

> The original Food and Drug Act is passed by Congress on June 30 and
> signed by President Theodore Roosevelt. The Act outlaws states from
> buying and selling food, drinks, and drugs that have been mislabeled
> and tainted.

**[1911]{.underline}**

> In **U.S. v. Johnson**, the Supreme Court rules that the 1906 Food and
> Drugs Act does not outlaw false medical claims but only false and
> misleading statements about the ingredients or identity of a drug.

**[1912]{.underline}**

> Congress passes the **Sherley Amendment** to overcome the ruling in
> U.S. v. Johnson. The Act outlaws labeling medicines with fake medical
> claims that is meant to trick the buyer.

**[1930]{.underline}**

> The name of the Food, Drug, and Insecticide Administration is
> shortened to **Food and Drug Administration (FDA)** under an
> agricultural appropriations act.

**[1933]{.underline}**

> FDA recommends a total rewrite of the out-of-date 1906 Food and Drugs
> Act.

**[1937]{.underline}**

> **Elixir Sulfanilamide**, contain the poisonous liquid, diethylene
> glycol, kills 107 persons, many of whom are children, dramatizing the
> need to establish drug safety before marketing and to pass the pending
> food and drug law.

**[1938]{.underline}**

> Congress passes **The Federal Food, Drug, and Cosmetic (FDC) Act** of
> 1938, which requires that new drugs show safety before selling. This
> starts a new system of drug regulation. The Act also requires that
> safe limits be set for unavoidable poisonous matter and allows for
> factory inspections.
>
> The Federal Trade Commission is given power to oversee advertising for
> all FDA- regulated products except prescription drugs.
>
> FDA states that sulfanilamide and other dangerous drugs must be given
> under the direction of a medical expert. This begins the **requirement
> for prescription only (non-narcotic) drugs** (see 1951 Durham-Humphrey
> amendment).

**[1941]{.underline}**

> Nearly 300 deaths and injuries result from the use of sulfathiazole
> tablets, an antibiotic, tainted with the sedative, phenobarbital. In
> response, FDA drastically changes manufacturing and quality controls.
> These changes lead to the development of **good manufacturing
> practices (GMPs).**

**[1948]{.underline}**

> The Supreme Court rules in **U.S. v. Sullivan** that FDA jurisdiction
> extends to retail stores, thereby allowing FDA to stop illegal sales
> of drugs by pharmacies including barbiturates and amphetamines.

**[1950]{.underline}**

> In **Alberty Food Products Co. v. U.S.**, a U.S. Court of Appeals
> rules that the directions for use on a drug label must include the
> drug's purpose.

**[1951]{.underline}**

> Congress passes the **Durham-Humphrey Amendment**, which defines the
> kinds of drugs that cannot be used safely without medical supervision.
> The amendment limits sale of these drugs to prescription only by a
> medical professional. All other drugs are to be available without a
> prescription.

**[1952]{.underline}**

> A nationwide investigation by FDA reveals that chloramphenicol, an
> antibiotic, caused nearly 180 cases of often deadly blood diseases.
> Two years later FDA engages the American Society of Hospital
> Pharmacists, the American Association of Medical Record Librarians,
> and later the American Medical Association in a **voluntary program of
> drug reaction reporting**.

**[1953]{.underline}**

> The **Factory Inspection Amendment** clarifies previous law and
> requires FDA to give manufacturers written reports of conditions seen
> during inspections and results of factory samples.

**[1962]{.underline}**

> **Thalidomide**, a new sleeping pill, causes severe birth defects of
> the arms and legs in thousands of babies born in Western Europe. The
> U.S. media reports on how Dr. Frances Kelsey, a FDA medical officer,
> helped prevent approval and marketing of Thalidomide in the United
> States. These reports stirred up public support for stronger drug
> laws.
>
> Congress passes the **Kefauver-Harris Drug Amendments**. For the first
> time, these laws require drug makers to prove their drug works before
> FDA can approve them for sale.
>
> The Advisory Committee on Investigational Drugs meets for the first
> time. This was the **first meeting of a committee to advise FDA** on
> product approval and policy on an ongoing basis.

**[1966]{.underline}**

> FDA contracts with the National Academy of Sciences/National Research
> Council to measure the **effectiveness of 4,000 marketed drugs**
> approved on the basis of safety alone between 1938 and 1962.
>
> The **Fair Packaging and Labeling Act** requires all consumer
> products, in interstate commerce, to be honestly and informatively
> labeled.

**[1968]{.underline}**

> FDA forms the **Drug Efficacy Study Implementation (DESI)** to carry
> out recommendations of the National Academy of Sciences Investigation
> of the effectiveness of drugs first sold between 1938 and 1962.

**[1970]{.underline}**

> FDA requires the first **patient package insert**, medicines must come
> with information for the patient about risks and benefits.

**[1972]{.underline}**

> **Over-the-Counter Drug Review** begins to enhance the safety,
> effectiveness and appropriate labeling of drugs sold without
> prescription.

**[1973]{.underline}**

> **The U.S. Supreme Court** upholds the 1962 drug effectiveness law and
> approves FDA's action to control entire classes of products.

**[1982]{.underline}**

> **FDA issues Tamper-resistant Packaging Regulations** to prevent
> poisonings such as deaths from cyanide placed in Tylenol capsules.
> Congress passes the Federal Anti-Tampering Act in 1983, making it a
> crime to tamper with packaged consumer products.

**[1984]{.underline}**

> **Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman
> Act)** increases the availability of less costly generic drugs by
> allowing FDA to approve applications for generic versions of
> brand-name drugs without repeating the research that proved the safety
> and effectiveness of the brand-name drugs. The Act also allowed
> brand-name companies to apply for up to five years additional patent
> protection for the new medicines they developed to make up for time
> lost while their products were going through FDA\'s approval process.

**[1989]{.underline}**

> The FDA issued guidelines asking drug makers to decide if a drug is
> likely to have **usefulness in elderly people** and to include elderly
> people in studies when applicable.

**[1991]{.underline}**

> In 1981, the FDA and the Department of Health and Human Services
> published a ~~policy~~ on protecting people in research. In 1991, this
> policy is adopted by more than a dozen federal agencies involved in
> human subject research and becomes known as the **Common Rule**.

**[1993]{.underline}**

> FDA launches **MedWatch**, a system designed to collect reports from
> health professionals on problems with drugs and other medical
> products.
>
> FDA issues guidelines for measuring **gender differences in responses
> to** **medication**. Drug companies are encouraged to include patients
> of both sexes in their research of drugs and to study any
> gender-specific effects.

**[1995]{.underline}**

> FDA declares **cigarettes** to be \"drug delivery devices.\" Limits
> are issued on marketing and sales to reduce smoking by young people.

**[1998]{.underline}**

> FDA introduces the **Adverse Event Reporting System (AERS),** a
> computerized database designed to store and study safety reports on
> already marketed drugs.
>
> The **Demographic Rule** requires that a marketing application review
> data on safety and effectiveness by age, gender, and race.
>
> The **Pediatric Rule** requires drug makers of selected new and
> existing drugs to conduct studies on drug safety and effectiveness in
> children.

**[1999]{.underline}**

> Creation of the **Drug Facts Label** for OTC drug products. The law
> requires all over-the-counter drug labels to have information in a
> standard format. These ***drug facts*** labels are designed to give
> the user easy-to-find information.

**[2000]{.underline}**

> The U. S. Supreme Court, upholds an earlier decision from Food and
> Drug Administration v. Brown & Williamson Tobacco Corp. et al. and
> rules 5-4 that **FDA does not have authority to regulate tobacco as a
> drug**.

**[2002]{.underline}**

> **The Best Pharmaceuticals for Children Act,** in exchange for
> studying the drug in children, the drug maker gets six months of
> selling their product without competition.

**[2003]{.underline}**

> The Pediatric Research Equity Act gives FDA the right to ask drug
> companies to study the effectiveness of new drugs in children.

**[2004]{.underline}**

> FDA advises medical professionals to limit the use of a pain reliever
> called Cox-2, a nonsteroidal anti-inflammatory drug (NSAIDs). Studies
> had shown that long-term use raised chances of heart attacks and
> strokes. The warning is also added to the over-the-counter NSAIDs'
> *Drug Facts* label.
>
> Medicines used in hospitals must have a bar code to prevent patients
> from receiving the wrong medicine.

**[2005]{.underline}**

> The **Drug Safety Board** is formed, consisting of FDA staff and
> representatives from the National Institutes of Health and the
> Veterans Administration. The Board advises the Director, Center for
> Drug Evaluation and Research, FDA, on drug safety issues and works
> with the agency in sharing safety information to health professionals
> and patients.
>
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> height="1.538888888888889in"}