Present (all from FDA)
Dr. Charles C. Edwards, Commissioner of Food and Drugs
Dr. John J. Jennings, Associate Commissioner for Medical Affairs
Mr. Peter B. Hutt, General Counsel
Mr. Gary Yingling, General Counsel
Mr. Sam Fine, Associate Commissioner for Compliance
Dr. Philip Walters, Director, OTC Staff, OSE
Wirth Baker, M.D.
American Institute of Homeopathy.
Maesimond Panos, M.D.
Harris Coulter, M.D.
Mr. Roger Ehrhart
President, Ehrhart and Karl
Chicago, Illinois –
William G. Onlhausen
The homeopathic representatives came in to discuss what place homeopathic preparations may have in the OTC drug review.
There was a general discussion relating to the background of homeopathy, the size of the market for homeopathic preparations ($1.5 M/year with 800-1000 homeopathic remedies being utilized), and the scope of homeopathic practice in the U.S. (approximately 2000 doctors who use homeopathic medications).
The question was then posed by the visitors as to whether or not homeopathic drugs are to be included in the OTC review and, if so, would these drugs be given any special consideration. Mr. Hutt replied that the question of homeopathic drugs really hasn’t been considered at this point.
Mr. Hutt then raised the question as to what types of data are presently available to support the safety and efficacy of currently marketed homeopathic drug products. They then ensued a description by the visitors as to how and by whom homeopathic drugs have been tested. It was pointed out that the vast majority of testing was done in the 19th century and has not since been repeated; recent documented research reports would not be available except in very limited numbers. The visitors stated that homeopathic “proving” is quite different from pharmacologic testing in that the basis of homeopathy is the utilization of a drug with a particular pathogenicity which matches the symptoms of the particular patient being treated; the medications used are matched to the “totality” of the individual being treated without a statistical determination of efficacy being attempted.
The visitors stated that approximately one-third of the homeopathic remedies used are truly OTC in that they are not dispensed by a homeopathic physician.
In conclusion, Mr. Hutt recommended that official comments should be provided to the agency in response to the January 5, 1972 FEDERAL REGISTER OTC review proposal. After receipt of these comments the agency will consider how best to deal with this particular situation.
Philip G. Walters, M.D.
PG Walters: sgp 3/13/72
This page was posted on August 23, 2009