Date: July 8, 1998



To: Subcommittee on the Constitution

Committee on the Judiciary

U.S. House of Representatives

H2-362 Ford House Office Building

Washington, DC 20515



From: Douglas J. Pisano, R.Ph., Ph.D.

Associate Professor of Pharmacy Administration

Division of Pharmaceutical Sciences

Massachusetts College of Pharmacy

and Allied Health Sciences

179 Longwood Avenue

Boston, MA 02115



RE: Lethal Drug Abuse and Prevention Act of 1998 (H.R. 4006)





Mr. Hyde and Members of the Committee,



I'm here today to speak in favor of the "Lethal Drug Abuse and Prevention Act of 1998" (H.R. 4006). I have had a chance to review the content and purpose of the legislation and in my opinion, feel that it would not hinder the efforts of any healthcare worker who is trying to provide appropriate pain control to patients who are terminally ill.



My comments today center on various aspects of the Controlled Substances Act of 1970 (CSA). As I'm sure you are aware, the CSA sets uniform federal standards for control of potentially dangerous drugs, in conformity with international covenants on drug control and in recognition of the extent to which traffic in legal and illegal drugs involves interstate commerce.(1)



One of these standards applies to the registration of practitioners who prescribe federally controlled substances to treat patients. This registration, issued by the Drug Enforcement Administration (DEA), allows these practitioners to prescribe federally controlled substances for "legitimate medical purpose." It is this concept of "legitimate medical purpose" that I wish to address.



"The phrase "legitimate medical purpose" implies that there must be a corresponding "illegitimate medical purpose." The phrase illegitimate medical purpose" lacks meaning, however, because medicine is by definition legitimate."(2)



Therefore, the notion that a law or statute or ruling that permits a registrant to write prescriptions for an "illegitimate medical purpose " is moot. My point is, DEA registrants, would in my opinion be practicing outside the boundaries of their prescriptive authority -illegitimately- when and if they prescribed medications not deemed by the medical community as being legitimate.



Clearly, DEA regulations state,



" A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate or authorized research is not a prescription under the meaning and intent of the Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances."(3)



The November 5th interpretation by Mr. Constantine of the DEA in response to an inquiry from Representative Hyde and Senator Hatch, Chairmen of the House and Senate Judiciary Committees, is both sensible and proper. The federal Controlled Substances Act supports the notion that physicians are forbidden from prescribing controlled substances for other than legitimate medical purpose. To my knowledge, assisted suicide, is not considered to be a legitimate medical purpose for prescription in the vast majority of our states or by the medical community.



Further, each state has the authority or "right" to enact laws and regulations as a counterpart to the federal for the purpose of controlling the manufacture, distribution and sale of drugs within the state and the regulation of the practice of healthcare professionals. Since one state's drug control laws may vary greatly from the federal, certain basic principles must be followed by health professionals in order to comply.



For example:(4)

1) Health professionals are responsible to the same degree for compliance with both federal and state laws and regulations that govern their practice.

2) A state drug control law or regulation may be more stringent than its federal counterpart.

3) Health professionals must comply with a state drug control law or regulation when it is more strict or when there is no similar prohibition or requirement under federal law.

4) If a federal drug control law or regulation is more stringent than the comparable state law or regulation, the federal regulation must be followed.



These points suggest that while "states rights" regarding DEA registrants are important, the CSA provides for a stricter, uniform national standard for behavior to control dangerous drugs and enforce regulations independent of state law.



In deference to the Attorney General's statement on Oregon's "Death with Dignity Act" of June 5th, 1998, the Attorney General states,



"The CSA is essentially silent with regard to regulating the practice of medicine that involves legally available drugs except for certain specific regulations dealing with the treatment of addicts."



My view is diametrically opposed. As I have explained, the CSA speaks to the regulation of medical practice with regard to legally available drugs when it refers to "legitimate medical purpose." States are also within their statutory purview when regulating medical practice with regard to legally available drugs so long as they consider the national concept of "legitimate medical purpose."



I therefore support the "Lethal Drug Abuse and Prevention Act of 1998" (H.R. 4006). I am in agreement that the Act would serve to strengthen and clarify the CSA. Its longstanding limits on the prescribing and dispensing of controlled substances benefit those in the American medical and scientific community who are in the service of their patients.

Judiciary Homepage




1. 21 USC 801(a)

2. Abood, RA, Brushwood, DB, "Pharmacy Practice and the Law", Aspen Publishers, Gaithersburg, Md, 1994, pp.130

3. 21CFR1306.04 (a) Purpose of issue of prescriptions.

4. Fink, JL, Marquardt, KW, Simonsmeir, LM, PHARMACY LAW DIGEST, 26th, Facts and Comparisons, Inc, St. Louis, MO, Nov.1995, pp. CS-4 p.CS-4