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

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

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408Dr. Edwards. No; I wouldn't know what that $17.3 million figureis. I would have to see how it was broken down.Mr. Brasco. Well, could you tell us what portion of this money,if any, is being used to develop new drugs?Dr. Edwards. Well, of course, I can't speak concerning the developmentof new drugs by the National Institute of Mental Health.None of our money is going directly into the development of newdrugs.Mr. Brasco. So you don't have a research budget, as such?Dr. Edwards. We have a research budget, but not for the developmentof new drugs in this area.Mr. Brasco. What would that money be for? What would you beresearching?Dr. Edwards. Oh, we are doing a lot of things. We are dohig a lot oftoxicological research in the heavy metals. We are doing research workin the pharmaceutical field.Mr. Brasco. But not hi the area of drugs that could be used in theproblem of drug addiction.Dr. Edwards. No. Our role is not in new drug development.Mr. Brasco. I don't want to take all of the time, and I don't,gentlemen, want it to be understood that I want to appear to beunfriendly, but I iliink part of the problem that we have here reallyis that most of the ]3eople that we have heard from have said that wedon't have adequate statistics as to how many drug addicts we have.We don't have adecpiote r.tatistics as to how many people are involvedin what programs, and how they are making out. We are talking aboutminuscule amounts of moneys used for research development of newdrugs in th^s particular area. We are talking about our mability toconvince the Government of South Vietnam, where we have expendedmone}^ and men, to help us in this problem.France is a great friend of ours and I think owes us approximately$7 billion and we can't convince them they ought to do somethingabout breaking down the laboratories that make heroin.I think that unless we are all ready, and this is not looking for afall guy in anjT- partisan way because I think the only people that arefalling are the American pubhc as a result of this problem, unless weput together a concentrated effort of research and want to crush anddestroy the sources of this, we are just going to be going around incircles.And with that, Ithank you, Mr. Chairman.Chairman Pepper. Thank you.Mr. Wiggins?Mr. Wiggins. Yes, Mr. Chairman.Dr. Edwards. Mr. Chairman, may I make just one comment?I certainly agree with what you have said. I think that for the fii'sttime, at least since I have been here, this coordinated effort on thepart of all of the Federal agencies, particularly those that are involvedin tliis program, is just beginning to take on a head of steam, and itcame about first with the passage of our new regulations, and I feel,for the first time, a great deal more optimistic about the total Governmenteffort than I have been in the past.Chairman Pepper. Mr. Wiggins.

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

408Dr. Edwards. No; I wouldn't know what that $17.3 million figureis. I would have to see how it was broken down.Mr. Brasco. Well, could you tell us what portion of this money,if any, is being used to develop new drugs?Dr. Edwards. Well, of course, I can't speak concerning the developmentof new drugs by the National Institute of Mental Health.None of our money is going directly into the development of newdrugs.Mr. Brasco. So you don't have a <strong>research</strong> budget, as such?Dr. Edwards. We have a <strong>research</strong> budget, but not for the developmentof new drugs in this area.Mr. Brasco. What would that money be for? What would you be<strong>research</strong>ing?Dr. Edwards. Oh, we are doing a lot of things. We are dohig a lot oftoxicological <strong>research</strong> in the heavy metals. We are doing <strong>research</strong> workin the pharmaceutical field.Mr. Brasco. But not hi the area of drugs that could be used in theproblem of drug addiction.Dr. Edwards. No. Our role is not in new drug development.Mr. Brasco. I don't want to take all of the time, <strong>and</strong> I don't,gentlemen, want it to be understood that I want to appear to beunfriendly, but I iliink part of the problem that we have here reallyis that most of the ]3eople that we have heard from have said that wedon't have adequate statistics as to how many drug addicts we have.We don't have adecpiote r.tatistics as to how many people are involvedin what programs, <strong>and</strong> how they are making out. We are talking aboutminuscule amounts of moneys used for <strong>research</strong> development of newdrugs in th^s particular area. We are talking about our mability toconvince the Government of South Vietnam, where we have expendedmone}^ <strong>and</strong> men, to help us in this problem.France is a great friend of ours <strong>and</strong> I think owes us approximately$7 billion <strong>and</strong> we can't convince them they ought to do somethingabout breaking down the laboratories that make heroin.I think that unless we are all ready, <strong>and</strong> this is not looking for afall guy in anjT- partisan way because I think the only people that arefalling are the American pubhc as a result of this problem, unless weput together a concentrated effort of <strong>research</strong> <strong>and</strong> want to crush <strong>and</strong>destroy the sources of this, we are just going to be going around incircles.And with that, Ithank you, Mr. Chairman.Chairman Pepper. Thank you.Mr. Wiggins?Mr. Wiggins. Yes, Mr. Chairman.Dr. Edwards. Mr. Chairman, may I make just one comment?I certainly agree with what you have said. I think that for the fii'sttime, at least since I have been here, this coordinated effort on thepart of all of the Federal agencies, particularly those that are involvedin tliis program, is just beginning to take on a head of steam, <strong>and</strong> itcame about first with the passage of our new regulations, <strong>and</strong> I feel,for the first time, a great deal more optimistic about the total Governmenteffort than I have been in the past.Chairman Pepper. Mr. Wiggins.

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