STATEMENT OF THE NATIONAL ASSOCIATION OF RETAIL DRUGGISTS THE DESIGNER DRUG ENFORCEMENT ACT OF 1985 September 18, 1985 Mr. Chairman, Members of the Committee: I am John W. White of Tallahassee, Florida. I serve as President of the National Association of Retail Druggists. With me today is John Rector, our Director of Government Affairs. The National Association of Retail Druggists (NARD) represents owners of more than 30,000 independent pharmacies, where over 75,000 pharmacists dispense more than 70 percent of the nation's prescription drugs. Together, they serve 18 million persons daily.1 NARD has long been acknowledged as the sole advocate for this vital component of the free-enterprise system. NARD members are primarily family businesses. They have roots in America's communites. The neighborhood independent druggist typifies the reliability, stability, yet adventuresomeness, has made our country great. that We are especially pleased to present our views to the Committee on proposed amendments to the Controlled Substances Act, which will create new penalties for the manufacturing with intent to distribute, the possession with intent to distribute, or the distribution of "designer drugs", and for other purposes. We would like to express our special appreciation to the Committee, its Chairman, and Staff for their thorough but expeditious consideration of this important legislation. In 1982, independents filled 1,039,893,000 and chains filled 421,989,000 prescriptions of the total prescriptions (1,461,822,000) filled in the U.S. The average prescription price in 1982 for independents was $8.22 and for chains $8.29. Of the 210,493,000 prescriptions filled under the Medicaid program, chains filled 34,849,000 and independents filled 175,644,000. See American Druggist prescription survey May 1983. 2Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, P.L. 91-513, 84 Stat 1736, enacted 10/27/70, effective 5/1/71, is known as the Controlled Substances Act (21 USC 801 et.seq.). When the proposals, which eventually became the CSA, were before the Congress, NARD supported this landmark reform. It was a major step forward in bringing together into a single statute the scattered and fragmented laws relating to controlled drugs. In the intervening years, we have worked closely with federal agencies responsible for its implementation to help assure that the law and its regulations were understood by pharmacists and that our communities were protected from drug diversion and abuse. We appreciate the opportunity to continue this effort on behalf of independent retail pharmacy today. The National Association of Retail Druggists has monitored the emergence of so-called designer drugs with an ever-increasing degree of alarm. In the 98th Congress, we strongly supported the enactment of the Drug Diversion Control Act of 1984. As relates to the subject of today's hearing, we strongly supported provisions which authorized the Drug Enforcement Administration to exercise emergency scheduling authority when necessary to address the public health hazards and complex law enforcement issues presented by the manufacture, distribution, and abuse of designer drugs.d We were concerned that the emergency scheduling authority, as originally drafted, was far too broad, and we were pleased when the Chairman and his colleagues agreed to a modification so that only drugs not approved for medical use could be the subject of the new emergency scheduling authority. The recent exercise of the new authority by DEA in the instances of 1-methyl-4-phenylpropionoxypiperidine (MPPP) and 1(2-phenylethyl)-4-phenylacetyloxypiperdine (PEPAP) demonstrates the efficacy of the modified appropach, which could in no way deny due process to the retail pharmacists we represent, who have numerous controlled substances with approved medical usefulness in their inventory. We have supported a number of bills addressing the serious problems posed by designer drugs. We had strongly supported Senator Chiles' legislation, S.746, which would require the National Drug Enforcement Policy Board to provide a comprehensive assessment of the Designer Drug Program and make recommendations to Congress for additional legislation, and its counterpart in the House, H.R. 2014, introduced by Congressman Charles B. Rangel, Chairman of the House Select Committee on Narcotics Abuse and Control. Today, we are pleased to indicate our strong support for S.1437, the Designer Drug Enforcement Act of 1985. By providing penalties up to $250,000 or imprisonment of not more than fifteen years, or both sanctions, S.1437 will, in our view, provide an important deterrent for any person who knowingly, or intentionally manufactures with intent to distribute, possesses with intent to 45 CT: 45 may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with § 46.116 of Subpart A. (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by § 46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §§ 46.404 or 46.405. Where research is covered by §§ 46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. (c) In addition to the provisions for waiver contained in § 46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition. (d) Permission by parents or guardians shall be documented in accordance with and to the extent required by § 46.117 of Subpart A. (e) When the IRB determines that assent is required, it shall also (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. |