- Email: [email protected]
Legal Blotter
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,Legal Blotter
III'" --------
by Robert F. Steeves, director of APhA's legal division
the barb in barbiturate-amphetamine control proposals For more than a decade, Congress has been examining abuse of stimulant and depressant drugs and holding hearings on various proposals designed to correct the problem, The record established now constitutes numerous volumes. Early proposals revolved around bringing barbiturates and, later, amphetamines under the narcotic laws but this approach was abandoned when the Treasury Department stated that the constitutionality of the entire narcotic law might be jeopardized. Current proposals and those of recent years have attempted to establish a type of semi-continuous record under the provisions of the federal Food, Drug and Cosmetic Act similar, in many respects, to that provided under the Harrison Narcotic Act for narcotics. And this is where the profession of pharmacy becomes enmeshed in the proposals which ostensibly seek to place curbs on the illicit trafficking in stimulant and depressant drugs. That there is a problem with illicit distribution of stimulant and depressan t drugs is agreed by unanimous consent. Differences do exist as to the cause of the problem and the scope of a law needed to correct the abuses. Pharmacists are covered by the current proposals-the most prominent being HR 2 by Congressman Harris and S 438 by Senator Dodd-because the proponents of this legislation believe that pharmacists represent a group with a long record of illegal sales of amphetamines and barbiturates. This is false. All reasonable explanations have been offered. APHA. presented the profession's case before the House interstate and foreign commerce committee last month and the comments were favorably received. The profession'S dilemma stems from a bare statistic reported by FDA and given added weight by inclusion in the report of the President's Advisory Commission on Narcotic and Drug Abuse released in the fall of 1963In the ten-year period ending December 31,1962, there were 1,658 firms and individuals convicted under the federal Food, Drug and Cosmetic Act for the illegal sale of amphetamine
and/or barbiturates. Of these convictions 1,298, or 78 percent of the total, involved retail drug firms, pharmacists or their employees. This figure is unfortunate, for these offending pharmacies and pharmacists represent only a small fraction of the nation's total and indict the rest of the profession by these acts.
Since that time, pharmacists have been categorized as representing 78 percent of the illicit distributors of amphetamine and barbiturates and this is a serious charge to overcome. First, it should be noted that FDA Commissioner Larrick told the House interstate and foreign commerce committee last month that there were 1,100 pharmacist-violations in the ten-year figure. But, most important, is that the Durham-Humphrey Amendment became effective around 1952 and the record would undoubtedly show that FDA obtained a number of pharmacistviolations in the first years of implementation of that new law for unauthorized renewals. The number of pharmacistviolators has decreased from the 110 per year the ten-year total would suggest. During 1964, the FDA Enforcement and Compliance Reports lists 45 pharmacist-violations for illegal sales of stimulant and depressant drugs. Of this total, 12 cases involved unauthorized renewals only and seven others involved unauthorized renewals plus illegal sales, leaving 26 violations involving only illegal sales of prescription drugs. This is a substantial reduction from the 62 charges against ((drugstores or licensed pharmacists" FDA reported for fiscal 1961. These last two categories are not precise and perhaps more of these convictions are based on unauthorized renewals. Senator Dodd has been scoring the pharmacists for this record of representing 78 percent of the convictions for illegal sales of amphetamine and barbiturates. FDA has been content to let the figure linger in this most unfavorable connotation without explaining the details of it-and quite naturally since FDA wants pharmacists included. Furthermore, APHA is the only group to cite more recent figures placing the role of pharmacists in proper perspective.
Phase two in examining this statistic is to compare the amounts involved in the pharmacist-violations. An unauthorized renewal conviction may represent 12, 24 or 100 capsules, but it has no relation to the hundreds of thousands involved in bootlegging. FDA has not cited amounts involved and probably for the same reason that the percentage figure is left unexplained. Yet FDA estimates that about half of the amphetamine and barbiturates produced in this country each yeararound 4.5 billion doses-end up in the illicit market. The statistic cited by FDA and parroted by the Advisory Commission and others means only one thing-that FDA can and is enforcing the current law covering amphetamine and barbiturates where pharmacists are concerned but is doing a poor job with the illicit distributors. It also points out that FDA can adequately police the distribution of amphetamines and barbiturates within professional channels which is APHA's chief contention. Under the present law, a pharmacist who violates the Durham-Humphrey Amendment is subject to criminal action and FDA reports these actions regUlarly. More importantly, a pharmacist can lose his license to practice his profession which is certainly a stronger deterrent than the criminal conviction in most cases. HR 2 would add regUlatory tools to make apprehension of illicit peddlers easier and while some people in Washington question the need for this additional authority, FDA has not coped or been able to cope with the problem to date. The President's Advisory Commission reported that "this is partially due to a grossly inadequate staff of properly trained and equipped enforcement agents." The record of the practitioners of pharmacy does not warrant their inclusion in the class of illicit distributors. Present law has not proved to be inadequate in the regulation of prescription drug distribution in legitimate channels. Finally, provisions of HR 2 would add nothing to FDA's enforcement efficiency over pharmacists. Vol. NS5 , No.3, March 1965
171
I
~ ..........-
,Legal Blotter
III'" --------
by Robert F. Steeves, director of APhA's legal division
the barb in barbiturate-amphetamine control proposals For more than a decade, Congress has been examining abuse of stimulant and depressant drugs and holding hearings on various proposals designed to correct the problem, The record established now constitutes numerous volumes. Early proposals revolved around bringing barbiturates and, later, amphetamines under the narcotic laws but this approach was abandoned when the Treasury Department stated that the constitutionality of the entire narcotic law might be jeopardized. Current proposals and those of recent years have attempted to establish a type of semi-continuous record under the provisions of the federal Food, Drug and Cosmetic Act similar, in many respects, to that provided under the Harrison Narcotic Act for narcotics. And this is where the profession of pharmacy becomes enmeshed in the proposals which ostensibly seek to place curbs on the illicit trafficking in stimulant and depressant drugs. That there is a problem with illicit distribution of stimulant and depressan t drugs is agreed by unanimous consent. Differences do exist as to the cause of the problem and the scope of a law needed to correct the abuses. Pharmacists are covered by the current proposals-the most prominent being HR 2 by Congressman Harris and S 438 by Senator Dodd-because the proponents of this legislation believe that pharmacists represent a group with a long record of illegal sales of amphetamines and barbiturates. This is false. All reasonable explanations have been offered. APHA. presented the profession's case before the House interstate and foreign commerce committee last month and the comments were favorably received. The profession'S dilemma stems from a bare statistic reported by FDA and given added weight by inclusion in the report of the President's Advisory Commission on Narcotic and Drug Abuse released in the fall of 1963In the ten-year period ending December 31,1962, there were 1,658 firms and individuals convicted under the federal Food, Drug and Cosmetic Act for the illegal sale of amphetamine
and/or barbiturates. Of these convictions 1,298, or 78 percent of the total, involved retail drug firms, pharmacists or their employees. This figure is unfortunate, for these offending pharmacies and pharmacists represent only a small fraction of the nation's total and indict the rest of the profession by these acts.
Since that time, pharmacists have been categorized as representing 78 percent of the illicit distributors of amphetamine and barbiturates and this is a serious charge to overcome. First, it should be noted that FDA Commissioner Larrick told the House interstate and foreign commerce committee last month that there were 1,100 pharmacist-violations in the ten-year figure. But, most important, is that the Durham-Humphrey Amendment became effective around 1952 and the record would undoubtedly show that FDA obtained a number of pharmacistviolations in the first years of implementation of that new law for unauthorized renewals. The number of pharmacistviolators has decreased from the 110 per year the ten-year total would suggest. During 1964, the FDA Enforcement and Compliance Reports lists 45 pharmacist-violations for illegal sales of stimulant and depressant drugs. Of this total, 12 cases involved unauthorized renewals only and seven others involved unauthorized renewals plus illegal sales, leaving 26 violations involving only illegal sales of prescription drugs. This is a substantial reduction from the 62 charges against ((drugstores or licensed pharmacists" FDA reported for fiscal 1961. These last two categories are not precise and perhaps more of these convictions are based on unauthorized renewals. Senator Dodd has been scoring the pharmacists for this record of representing 78 percent of the convictions for illegal sales of amphetamine and barbiturates. FDA has been content to let the figure linger in this most unfavorable connotation without explaining the details of it-and quite naturally since FDA wants pharmacists included. Furthermore, APHA is the only group to cite more recent figures placing the role of pharmacists in proper perspective.
Phase two in examining this statistic is to compare the amounts involved in the pharmacist-violations. An unauthorized renewal conviction may represent 12, 24 or 100 capsules, but it has no relation to the hundreds of thousands involved in bootlegging. FDA has not cited amounts involved and probably for the same reason that the percentage figure is left unexplained. Yet FDA estimates that about half of the amphetamine and barbiturates produced in this country each yeararound 4.5 billion doses-end up in the illicit market. The statistic cited by FDA and parroted by the Advisory Commission and others means only one thing-that FDA can and is enforcing the current law covering amphetamine and barbiturates where pharmacists are concerned but is doing a poor job with the illicit distributors. It also points out that FDA can adequately police the distribution of amphetamines and barbiturates within professional channels which is APHA's chief contention. Under the present law, a pharmacist who violates the Durham-Humphrey Amendment is subject to criminal action and FDA reports these actions regUlarly. More importantly, a pharmacist can lose his license to practice his profession which is certainly a stronger deterrent than the criminal conviction in most cases. HR 2 would add regUlatory tools to make apprehension of illicit peddlers easier and while some people in Washington question the need for this additional authority, FDA has not coped or been able to cope with the problem to date. The President's Advisory Commission reported that "this is partially due to a grossly inadequate staff of properly trained and equipped enforcement agents." The record of the practitioners of pharmacy does not warrant their inclusion in the class of illicit distributors. Present law has not proved to be inadequate in the regulation of prescription drug distribution in legitimate channels. Finally, provisions of HR 2 would add nothing to FDA's enforcement efficiency over pharmacists. Vol. NS5 , No.3, March 1965
171