A Las Vegas drug manufacturer has begun production of Gerovital, a controversial anti-depressant that has not been approved by the U.S. Food and Drug Administration.
But Rom-Amer Pharmaceuticals Ltd. Is going ahead with production anyway because the drug has been approved for intrastate use by the state of Nevada, and unless the FDA can prove there is interstate congress involved in the sale and production of Gerovital, Rom-Amer is home free.
Under the leadership of Marvin Kratter, a feisty former real estate mogul, Rom-Amer angrily withdrew its request for FDA approval last year, years after the drug first began testing toward approval.
At the same time, however, Kratter succeeded in efforts to get the Nevada state legislature to tack Gerovital on a bill to legalize Laetrile within state borders.
Last week, Rom-Amer received final permission from the Nevada State Commissioner of Food and Drugs to manufacture Gerovital, and production began this week.
The drug, which has been billed in Europe as a "fountain-of-youth" drug for older people, will be sold through drugstores and by doctors on a prescription-only basis, company officials said.
The FDA, however, is expected to scrutinize the operation carefully. FDA regional officials have said that if any aspect of the operation involves interstate commerce -- including such things as the production of labels for the bottles. or other raw materials -- they will close the entire operation down.