There have been considerable charges and counter-charges the United States Food and Drug Administration's role in protecting the consumer, at least as far as the medical profession is concerned. The FDA has absolutely no intention nor desire to assume the role of the physician or to interfere with the bona fide practice of medicine. Why the complaints by some the FDA's actions on drugs, including drug labelling, drug recall and the withdrawal of certain drugs from the market, constitute attempts to interfere with the practice of medicine? It is possible that one of the reasons, and perhaps the principal one, for this misunderstanding is the FDA's failure to communicate adequately its responsibility under the law to protect the patient and inform the doctor.
Herbert L. Ley Jr.,
The Doctor, the Patient, and the FDA,
19 Clev. St. L. Rev.
available at https://engagedscholarship.csuohio.edu/clevstlrev/vol19/iss1/6
Proceedings of American College of Legal Medicine