Guest Editorial: FDA Censorship

Abstract

This Journal [Clinical Pharmacology and Therapeutics] has avoided criticizing the FDA for its weaknesses and its failings because we have felt that it is charged with a virtually impossible job. Certain recent actions of the FDA, however, violate basic principles of science and education, and here the Editor feels that in the interest of the public and of medicine he must speak.

The FDA has now taken the stand that in this country it is the sole arbiter of drug dosage and that its pronouncements on this subject in drug package staffers are inviolate. In this vein it has already acted to prevent authors from publishing articles citing dosages which do not coincide with those appearing in current FDA-approved package staffers. Mr. William Goodrich of the Legal Department of the FDA has stated that publishers, authors, and editors who have written, approved, and published drug dosages which deviate from those recommended by the FDA are liable for damages to the patient and to the pharmaceutical manufacturer as well (because of damage to the good name of the manufacturer).