Pill Politics: Drugs and the FDA

Pill Politics: Drugs and the FDA

Pill Politics: Drugs and the FDA

Pill Politics: Drugs and the FDA


"The FDA's initial mandate to protect health grew out of pharmaceutical-related disasters in the early 1900s. Later criticisms that the agency's approach impeded industry competitiveness and failed to meet public need, however, led to a political compromise on its mission. The new FDA has cut its review time nearly in half and allows direct-to-consumer advertising, off-label promotion of drugs, and the "fast-tracking" of treatments. Ceccoli convincingly shows that this approval process, while redressing valid complaints, is also creating a new complex of problems that must be resolved." Title Summary field provided by Blackwell North America, Inc. All Rights Reserved


Doctors pour drugs of which they know little,/To cure diseases
of which they know less,/Into human beings of whom they
know nothing.


The United States is the most highly medicated society in the world. According to the National Association of Chain Drug Stores, more than 3 billion prescriptions were dispensed in the United States in 2002. Americans depend on prescription drugs in many ways and for a variety of reasons. For curative purposes, prescription medicines are dispensed to heal wounds, cure infections, and eradicate diseases. Other medicines are prescribed to enhance the quality of life of individuals suffering from conditions for which a medical cure has yet to be found. For cancer, diabetes, mental health, or AIDS patients, prescription medicines can not only prolong but also greatly improve life. For physically and mentally healthy individuals, so-called lifestyle drugs are being increasingly prescribed to enhance the quality of life in a much different context. In this case, prescription medicines can be used for purposes ranging from the treatment of male pattern baldness to the enhancement of sexual performance.

The increasing medication of Americans is an important component of the nation's overall health profile. Spending on prescription drugs now accounts for approximately 9.4 percent of all health care expenditures in the United States. In monetary terms, spending on outpatient prescription drugs in retail outlets in the United States exceeded $154 billion in 2001 (NIHCM, 2002). Such medicines enable Americans to lead happier, healthier, and ultimately longer lives. This latter point is . . .

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