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

414sible for someone to conceal from us certain facts that might haveresulted in his not having been granted a number. So I can't really tellyou the answer to that question. We can check it out and respond to it.As it stands now, before anybody is approved, he will be checked outby the Bureau of Narcotics and Dangerous Drugs for just this sort ofthing as well as b}^ the Food and Drug Administration for the scientificmerits of the protocol that he submits.(^J^hc following information, subsequently received from. M. J.Ryan, Director, Office of Legislative Services, FDA, was receivedfor the record :)QUESTIONIs it true the FDA has authorized or given IND numbers to physicians who havebeen convicted of violating the Harrison Act?ANSWERWe have no knowledge of having given an IND number to a physician convictedof violating the Harrison Act. We have checked with the Bureau of Narcoticsand Dangerous Drugs, Department of Justice, and they do not know of anyphysicians who have been convicted of violations. Investigations have been doneon IND sponsors and adverse findings have subsequently come to light concerningphysicians with IND's for methadone maintenance, flowever, we know of noHarrison Act convictions. With the new methadone regulations now in effect, theBureau of Narcotics and Dangerous Drugs does a background check on each newapplicant, which would prevent this possibility.Mr. Rangel. But, it is safe to sa}^, notwithstanding the statutorysanction that your Agency possesses, that any unscrupulous doctorcan feel free to dispense this drug, which you have authorized to be onthe market, without fear of an^^ sanction from your particular Agency.Dr. Jennings. We have no direct authority over that; tliat istrue.Mr. Rangel. Has there been any other drug that has been beforethe FDA that has been allowed, agreeing that you have not reachedany conclusions as to its safety, to be on the market to be used thiswidely for a 7-year period without being certified?Dr. Edwards. Probably not.Mr. Rangel. Are there political implications to why you \\'ill notreach a decision as to whether methadone is safe or not?Dr. Edwards. There are no political reasons as far as we areconcerned.Mr. Rangel. I am not talking about Democrat or Republican. Iam talking about the American Medical Association and the pharmaceuticalindustry.Dr. Edwards. No. I am referring only to the decisions we havemade on the drug.Mr. Rangel. Is it true that your statistical data would indicatethat this drug has been used mainly in treatment of low economicgroups in this Nation?Dr. Jennings. No. I don't think that is true, sir.Dr. Gardner. No; that is not true. Certainly it has been used intreatment of low economic groups, but by no means limited to that.Mr. Rangel. I don't mean restricted, but isn't it true that theoverwhelming number of addicts being treated by methadone are inthe low-income brackets?