Statement by the President Upon Authorizing an Agreement for a Worldwide Drug Reaction Monitoring System.
A WORLDWIDE early warning system for drugs will be a vital health protection measure for people everywhere. Increasingly powerful and sophisticated drugs emerge from laboratories as boons to the struggle against man's bodily afflictions. In actual use, however, some drugs have had unexpected and tragic consequences before medical communities could become aware of unpredictable side effects. This worldwide early warning system is a big step forward in protecting all people from these unforeseen hazards. We are glad to make this grant to assist in its establishment.
Note: The statement was made public as part of a White House release which announced that the President had authorized an agreement with the World Health Organization to establish an international system to monitor and report adverse drug reactions, and had delegated authority to Secretary of Health, Education, and Welfare John W. Gardner to implement the project (see Item 215). The cost for the first year of operation was estimated to be $180,000.
The release stated that computer and office facilities of the Food and Drug Administration in Washington, D.C., would be utilized to provide a worldwide monitoring center for the collection of information on reactions to drugs. Data on hazardous reactions could then be disseminated throughout the world.
The release further noted that interest in the development of an international reporting system was stimulated by the tragic births of thousands of deformed babies in Europe. The deformities were attributed to use of the sedative drug thalidomide by women during pregnancy (3 Weekly Comp. Pres. Docs, p. 724).
Lyndon B. Johnson, Statement by the President Upon Authorizing an Agreement for a Worldwide Drug Reaction Monitoring System. Online by Gerhard Peters and John T. Woolley, The American Presidency Project https://www.presidency.ucsb.edu/node/238673