FDA Approves Use of Experimental AIDS Drug : Newport Beach Firm, Which Has Not Agreed to Plan, Could Sell It at Cost

WASHINGTON — The Food and Drug Administration said Friday it will allow a California pharmaceutical company to provide an experimental drug to any AIDS victims whose doctors ask for it, but company officials said they have not agreed to such a plan.

The FDA, in an internal advisory, said it had agreed to let Newport Pharmaceuticals of Newport Beach conduct a “compassionate-use protocol” that would allow the drug Isoprinosine to be distributed, at the request of a doctor, to individual AIDS patients.

Sales would have to be at cost; no profit could be made.

Treatment Not Perfected

An FDA spokesman compared the drug to an experimental cancer treatment, explaining: “The fact that they’re not perfected becomes immaterial if your life expectancy is a week or a month.”

But company officials, advised of the FDA announcement by a reporter, said they were unaware of the action, had not agreed to broad distribution of the drug under the requirements stipulated by the FDA and doubted they could handle such a task.

Isoprinosine is not a cure for AIDS, or acquired immune deficiency syndrome, the FDA said. It is, however, one of about half a dozen drugs about to begin clinical trials and the FDA said it does not doubt the drug’s safety.

The drug reportedly is available legally in some 70 countries, including Mexico, where it is sold by a Newport licensee, Laboratories Sanfer Co.