Term
| The Drug Importation Act of 1848 |
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Definition
Signed by President James K. Polk, it was the first federal statute to protect citizens from harmful drugs, and it prohibited the importation of adulterated drugs.
The law addressed only those medicines that were imported. There was no provision for substandard domestic products. |
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Term
| Pure Food and Drug Act of 1906 (Wiley-Heyburn Act) |
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Definition
Prohibited interstate commerce of misbranded and adulterated food, drinks, and drugs.
It established a number of important points in the regulation of medicines, including the definition of drugs and misbranding and the establishment of standards by which medicines were to be judged for both purity and accuracy of labeling.
It did not require manufacturers to list ingredients or directions for use on the label, and it did not refer to false health claims. |
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Term
| Sherley Amendment (1912)(to the Pure Food and Drug Act) |
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Definition
Prohibited false and "fraudulent" label claims of therapeutic effectiveness.
This amendment was meant to address the primary weakness of the 1906 law, which was to prohibit false therapeutic claims. |
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Term
| The Sulfanilamide Tragedy (1937) |
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Definition
"Taste of Raspberries, taste of death"
Elixir preparation used Diethylene Glycol (DEG) as a solvent. Since DEG is poisonous, the preparation led to more than 100 deaths (mostly children). |
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Term
| Food, Drug, and Cosmetic Act of 1938 |
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Definition
The act prohibited marketing of a new drug until proven safe for use under conditions described on the label and approved by the FDA.
Marks the beginning of the "approval process" for drugs in the U.S. |
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Term
| Durham-Humphrey Amendment of 1951 |
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Definition
The amendment established two classes of drugs: Prescription Legend Drugs and "over the counter or nonprescription drugs"
Required that drugs that cannot be safely used without medical supervision be dispensed only by prescription of a licensed practitioner; Prescription drugs (legend drugs). The law also prohibited refills of prescriptions without express consent of the prescriber. |
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Term
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Definition
Drug marketed for its anti-nauseant properties in pregnancy.
Resulted in deformed babies: Phocomelia - characterized by defective, shortened limbs resulting in flipper hands and feet)
Since 1962, all drugs required to perform tests to determine teratogenic properties - for FDA approval. |
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Term
| Kefauver-Harris Amendment of 1962 |
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Definition
This amendment strengthened the drug approval process by requiring that drugs be proved not only safe but also effective. So anyone who wished to market a drug product had to demonstrate its efficacy (in addition to safety) to the FDA before it could be sold. - this requirement was also extended to products that had been approved between 1938 and 1962.
The amendment transferred the authority for regulating drug advertising from the Federal Trade Commission to the FDA.
It added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions. |
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Term
| Orphan Drug Act (ODA) of 1983 |
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Definition
| This act was passed to provide tax (50% of cost of human trials) and exclusive licensing incentives (seven-year marketing exclusivity) for manufacturers to develop and market drugs or biologicals for the treatment of rare diseases (diseases that affect fewer than 200,000 individuals). |
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Term
| Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) |
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Definition
Enacted to streamline the generic drug approval process while given patent extensions, in certain cases, to innovator drugs.
Eased the requirement for marketing generic drugs
Allowed for the extension of patents or periods of marketing exclusivity for pioneer drugs under certain conditions.
Generic drug companies did not have to perform clinical trials, but rather perform bioequivalence studies. |
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Term
| The Omnibus Budget Reconciliation Act of 1990 (OBRA) |
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Definition
1. Pharmaceutical manufacturers required to provide rebates to Medicaid
2. Government sponsored demonstration projects relating to the provision of pharmaceutical services
3. Mandatory DUR (prospective and retrospective including patient counseling) for Medicaid recipients. |
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Term
| Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003 |
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Definition
Led to the creation of Medicare Part D
- Eligible Medicare beneficiaries can choose and receive prescription drug benefits from different private plans approved by the CMS. |
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Term
| Food and Drug Administration (FDA) |
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Definition
Has the primary responsibility of enforcing the Food, Drug and Cosmetic Act (and its amendments)
Prescription drugs need to be approved by this before being marketed. |
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Term
| Federal Trade Commission (FTC) |
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Definition
| Responsible for regulating advertising claims for OTC drugs. |
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Term
| Center for Medicare and Medicaid Services (CMS) |
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Definition
| Has responsibility for administering the Medicare program and works in collaboration with the state governments to administer Medicaid, State's Children's Health Insurance Program (SCHIP) |
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Term
| Consumer Product Safety Commission (CPSC) |
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Definition
| enforces the Poison Prevention Packaging Act of 1970, which requires that oral prescription drugs and many other products be packaged (or dispensed in the case of Rx drugs) in "child-resistant" containers unless otherwise requested by the patient or prescriber. |
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Term
| Drug Enforcement Administration (DEA) |
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Definition
the federal agency responsible for enforcement of the Federal Controlled Substances Act of 1970.
- controls the manufacture and distribution of controlled substances, such as narcotics, stimulants, and depressants. It has widespread influence over how controlled substances are inventoried, ordered and dispensed in a pharmacy. |
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