Summary
A cornerstone of American medicine is physicians' ability to prescribe drugs for not-yet-approved uses, based on findings in the medical literature and their own clinical judgment.
This "practice of medicine" by physicians traditionally has not been constrained by federal drug regulators; and with the exception of certain "controlled substances," such as narcotics, generally drugs have been freely prescribed and advertised.See the full content of this document
Extract
A Worsening Condition
During the last several years, however, the increasingly risk- averse Congress and the FDA have been gradually moving toward "conditional," or limited, approvals of new drugs that place various restrictions on prescribing, distribution, sale and advertising.
At the same time, legislators and regulators have imposed additional requirements for the...See the full content of this document
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