The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
Currently Skimming:
8 State Laws and Regulations
8 State Laws and Regulations
Pages 173-186
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 173... ...
93-28 1 ~ but also under companion state laws. All states and the District of Columbia have regulations that are counterparts to the comprehensive federal regulatory structure for controlled substances (Chapter 7~.
|
From page 174... ...
Any perceived delay in a return on investment to a pharmaceutical company can influence the decision to develop a new antiaddiction medication. Inasmuch as this area is already perceived as a marginal business investment, the additional overlay of the state laws and regulations and the resulting delays can negatively influence manufacturers' decisions to enter the field.
|
From page 175... ...
approval. A consequence of this policy is that the regulatory process at the federal level is prolonged for all newly approved drugs that are controlled substances (Chapter 7~; this regulatory delay can become years when the rescheduling process requires both state and federal action and cannot
|
From page 176... ...
, to revise its policy on determining when a drug has a currently accepted medical use in treatment so that, for new therapeutic drugs that are also controlled substances, the process of scheduling can begin as soon as possible after submission of the NDA. Treatment Each state is responsible for approving narcotic treatment programs and for monitoring those programs for compliance with state regulations.
|
From page 177... ...
Until recently, methadone was the only medication approved for use in narcotic treatment programs, and state regulations were written only for methadone maintenance treatment. Once a new anti-addiction medication receives FDA approval for the treatment of drug dependence, the states must amend their methadone regulations before it is used in a program.
|
From page 178... ...
Patient Registries To prevent illegal diversion of controlled medications, the federal government prohibits treatment programs from administering medications, except in an emergency situation, to "a patient who is known to be currently receiving drugs from another treatment program," and requires that patients always report to the same treatment facility, unless permission is granted otherwise [21 CFR § 291.505(e)
|
From page 179... ...
Approved research programs are subject to inspection by panel members, staff, or hired consultants, and annual progress and final reports must be submitted to the panel (Research Advisory Panel, 1993) New York similarly requires state approval of clinical research involving Schedule I substances, and state licenses are required for anyone engaging in
|
From page 180... ...
Under current regulations, LAAM can be distributed only to clinics and hospitals that operate licensed narcotic treatment programs. Since the federal rescheduling of LAAM, BDC has been working with NIDA, FDA, DEA, Substance Abuse and Mental Health Services Administration (SAMHSA)
|
From page 181... ...
In July 1993, concurrent with FDA's approval of the LAAM NDA, those treatment regulations were amended specifically to include LAAM (Federal Register, 19933. LAAM, like methadone, may be dispensed only by treatment programs approved by FDA, DEA, and designated state authorities (21 CFR § 291.505~.
|
From page 182... ...
As of October 1994, only 24 states had completed the procedures to include LAAM in their narcotic treatment regulations not including California or New York (the states with 36% of the nation's narcotic treatment programs and about 45% of the opiate-dependent patient population~where the inclusion of LAAM requires legislative action that is not expected to be completed before 1995. Clinic Approval Each of the estimated 650 narcotic treatment programs (which can have more than one dispensing site; in 1992 FDA licensed 737 dispensing sites)
|
From page 183... ...
But the regulatory system into which LAAM has been forced takes no account of the fact that the drug was developed, in part, precisely because of specific qualities that make it less of a target for diversion than methadone. The net result is that a drug that would save money for treatment clinics and ultimately for taxpayers, that would benefit opiate-addicted patients, and that would reduce the potential for narcotic treatment products ending up in the street trade, languishes practically unused more than a year after federal approval and rescheduling.
|
From page 184... ...
The committee recommends that ONDCP, in cooperation with FDA, DEA, SAMHSA, and NIDA, take an active role in compiling relevant information about state regulatory processes for antiaddiction medications that are categorized as narcotics and educating state regulators and pharmaceutical company representatives about the processes and their practical consequences. To implement that recommendation, the following steps may be taken: · Conduct a comprehensive study of state laws and regulations pertinent to the development of anti-addiction medications that are controlled substances, and develop a step-by-step manual
|
From page 185... ...
· Modifying state laws and regulations for narcotic treatment programs to remove the need to reopen and amend the laws or regulations to accommodate each new product. Imposing specific deadlines for state regulatory action in response to FDA approval of a new anti-addiction medication that requires state action to be dispensed to patients.
|
From page 186... ...
1992. Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.