Drugs that generate more than $1 billion of revenue each year.
Center for Drug Evaluation and Research (CDER):
The division of the FDA responsible for assuring the safety and effectiveness of drugs for American consumers.
A factor that makes it inadvisable to administer a drug or carry out a medical procedure or treatment.
Representatives of pharmaceutical companies visiting physicians' offices to persuade them to prescribe their products. The representatives often give the physicians perks, such as free drug samples to give to patients.
Division of Drug Marketing, Advertising, and Communications (DDMACC):
A division under the FDA's Center for Drug Evaluation and Research that is responsible for reviewing prescription drug advertising to assure that prescription drug information is not misleading or false, but rather is accurately communicated and balanced.
After the patent protection of a brand-name drug expires, a generic version of the drug can be made available, pending approval from the FDA. Generally, generic drugs are less expensive than brand-name drugs.
Federal Food, Drug and Cosmetic Act (FFDCA):
Passed in 1938, the FFDCA gives authority to the FDA to oversee the safety of food, drugs, and cosmetics. One of the provisions of this act requires that new drugs be shown to be safe before marketing. This act sets the general standards for FDA's regulation of prescription drug advertising directed to consumers and physicians.
Government Accountability Office (GAO):
The investigative arm of Congress charged with auditing and evaluating government programs and activities.
Medications that are not medically necessary but are designed to improve the patient's quality of life. These drugs address conditions such as impotence, baldness and wrinkles.
When normal or nonmedical problems, such as acne and hair loss, become defined and treated as medical problems.
Pharmaceutical Research and Manufacturers of America (PhRMA):
Advocacy group representing pharmaceutical and biotechnology companies in the United States.