Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

409Mr. Wiggins. Dr. Jennings, does statutory authority exist to})ermit you to require the manufactiu'e of methadone in a noninjectableform?Dr. Jennings. I am not sure that I understand your question.Certainly we have the authority to approve drugs for safety andefficacy and that approval includes the formulation of the drug, thatis, the physical state in which it is marketed, as well as the labelingfor it, and we have requested the principal manufacturer to developthe dosage form that we were speaking about for this particularinvestigational use. But we haven't extended that particular requirementto the currently marketed forms of methadone for its otherindications, that is, as an ordinary analgesic or antitussive.It may very well be that its hazards or its usefulness in the maintenanceprogram would eventually be considered so great that itwould be in the interest of the public welfare to eliminate the dosageforms.That is something that certainly could be considered, and becausewe do have the authority to make an estimation of the benefit-to-riskratio, we could probably require a single nonabusable dosage form ifone could be developed.Mr. Wiggins. Have you answered my question; yes or no?Dr. Jennings. I think it is yes; but I think we would have to consultour legal people about it.Mr. Wiggins. Would you provide a fuller answer if, after consultation,you believe the answer to be no, and even if you believe theanswer to be yes, would you communicate with the committee andclear that matter up?Dr. Jennings. Yes; of course.(The following, in reference to the above request, was received fromM. J. Ryan, Director, Office of Legislative Services, FDA:)QUESTIONDoes statutory authority exist to permit FDA to require the manufacture ofmethadone in a noninjectable form?ANSWERYes. Under the terms of the Federal Food, Drug, and Cosmetic Act, a new drugmay not be marketed unless it has been approved as safe and effective by theFood and Drug Administration. If there is the possibility of safety problems(which could include problems related to drug abuse) using a particular dosageform of the drug, approval could be restricted to those dosage forms where thisproblem does not exist, or exists to a lesser degree.Mr. Steiger. Will my colleague yield?Mr. Wiggins. I will yield if you have a question.Mr. Steiger. I thank you. I wondered, assuming that we find alegal basis for this requirement, that methadone only be dispensed in anonabusable form, what criteria would you require to arrive at thatdecision?Dr. Jennings. In order to make such a decision we would, first ofall, have to make two decisions. One, that methadone is safe andeffective for the long-term maintenance treatment of heroin, and, two.that this use was so important vis-a-vis its other uses, that it wouldbe considered overriding and we would, therefore, eliminate, or at