Drugs and the public safety.

PIP: The basic Food, Drug, and Cosmetic Act of 1938, together with its accompanying amendments through 1965, now gives the Food and Drug Administration (FDA) sweeping authority to monitor and control the development, production, and use of drugs. The law provides the U.S. public with a degree of efficacy and safety of drugs which is unsurpassed in the world. The FDA insures the efficacy, as well as the safety, of a drug before it is put on the market. The FDA also oversees: 1) drug research; 2) manufacturing production; 3) records on experience with drugs; and 4) prescription drug advertising. It is important that the government perform these functions in a scientific but flexible manner and arrive at decisions through a consensus of medical experts rather than respond to pressure groups. The government's responsibility to the physician is one of 1) providing data on the efficacy and safety of drugs, but not directing which drug should be used; 2) not overemphasizing adverse animal-testing data without clinical confirmation; and 3) not stressing adverse drug experiences without a fair amount of certainty that a cause-effect relationship exists between the drug and the alleged reaction.^ieng