Exchange of Letters Between Governor Nelson Rockefeller and Secretary of HEW Elliot Richardson

April 19, 1972

Dear Mr. Secretary:

It has come to my attention that a great many published reports, written over a thirty-year period by physicians and other scientists, have indicated that the substance phenytoin has a broad range of beneficial uses. Further, it is my understanding that physicians are prescribing phenytoin for many purposes other than its original indicated use, in 1938, as an anti-convulsant. In spite of the evidence of phenytoin's broad usefulness, I understand that today, in 1972, its only listed indication is that of an anticonvulsant. I realize that the Food and Drug Administration is set up essentially to rectify errors of commission. This certainly does not fall into that category. However, I believe a public clarification of the status of phenytoin by the FDA would be most valuable, and timely. I enclose with this letter a publication, The Broad Range of Use of Phenytoin-Bibliography and Review, that extensively deals with this subject. I hope you will give this your consideration. With warm regard.

Sincerely,

/s/ Nelson A. Rockefeller s

June 22, 1972

Dear Governor Rockefeller:

Please forgive the delay of this response to your April 19 letter concerning the current status of the drug, phenytoin. Conversations with health officials within the Department have revealed that phenytoin (PHT) was introduced in 1938 as the first essentially nonsedating anticonvulsant drug. The dramatic effect of PHT and its widespread acceptance in the treatment of convulsive disorders may have tended to obscure a broader range of therapeutic uses. A review of the literature reveals that phenytoin has been reported to be useful in a wide range of disorders. Among its reported therapeutic actions are its stabilizing effect on the nervous system, its antiarrhythmic effect on certain cardiac disorders, and its therapeutic effect on emotional disorders. The fact that such broad therapeutic effects have been reported by many independent scientists and physicians over a long period of time would seem to indicate that the therapeutic effects of phenytoin are more than that of an anticonvulsant. The FDA encourages the submission of formal applications, which, of course, would include the necessary supporting evidence for the consideration of approval for a wider range of therapeutic uses. Your interest in encouraging the Department to provide a public clarification of the status of phenytoin is very welcome and I hope that this information is responsive to your concerns.

With warm regard, sincerely,

/s/ Elliot L. Richardson

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