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Appendix: The Effect of Controlled Substances Scheduling on Marijuana Research
(Although not discussed at the meeting, this section is provided as
background regarding
research with Schedule I substances.)
In addition to the requirements of the U.S. Food and Drug Administration (FDA)
and sponsoring
organizations such as the National Institutes of Health (NIH) concerning the
conduct of clinical
research, U.S. investigators are subject to specific FDA and Drug Enforcement
Agency (DEA)
regulations concerning research with controlled substances. Under the Controlled
Substances
Act (21 USC 822 (a)(1)) and implementing DEA regulations, persons conducting
clinical
research with any controlled substance must register with the DEA, keep specific
types of
records, and periodically report to the DEA. Marijuana is currently classified
at the highest
(most restrictive) level as a Schedule I drug (no accepted medical use, high
potential for abuse).
Attempts by various petitioners to have marijuana rescheduled have not been
successful.
Therefore, there is at least one extra layer (many States have their own laws
modeled after the
Controlled Substances Act (CSA), which add further complexity) for any
investigator undertaking
clinical trials with controlled substances. In the case of research conducted
under an Investigational
New Drug Application (IND), recordkeeping requirements are exempt from the CSA
but must be
kept in accordance with the Food, Drug and Cosmetic Act (FDCA). Under the FDCA,
a sponsor
or investigator must make its records concerning shipment, delivery, receipt, and
disposition
available for inspection and copying at DEA's request. Additionally, FDA
regulations require
that sponsors and investigators conducting clinical trials take special
precautions to prevent
diversion, including storage in a secure place with limited access. In the case
of some investigator
sites, this may require acquisition of a safe and/or other physical space changes
and/or procedures to
insure security and accountability of the substance.
The CSA also mandates reporting procedures when conducting research with
controlled substances.
A DEA registration for controlled substances also authorizes (within specified
limits) the
manufacture and distribution of the substances. If a researcher engages in
manufacture or
distribution, then he or she is held to the reporting standard of manufacturers
and distributors.
Presumably, the manufacturer/distributor reporting requirements would not apply
in most
studies, as the source of marijuana would be the National Institute on Drug Abuse
(NIDA) and
most studies would not be using the plant material to manufacture other forms or
products.
Where research studies of Schedule I substances are not conducted under an
IND, the DEA
requires a copy of the research protocol be submitted for approval and identify
in the registration
applications the extent to which the research will involve manufacture or
importation. Where
research is conducted under an IND, however, the sponsor need only provide the
DEA with a
copy of the IND and a statement of security precautions. The FDA has ultimate
authority to
decide whether the research may proceed either under its jurisdiction over INDs
(FDCA) or in
the case of non-IND research, under the CSA (21CFR1301.42). Where non-IND
research is
undertaken, the FDA must consult with the DEA concerning the adequacy of the
applicant's
diversion control procedures. If a researcher desires to increase the amount of
Schedule I
material it has previously received permission to use, it must apply to the DEA
for the increase,
and the DEA will forward the request to the FDA for approval/denial, taking into
account DEA
comments on the adequacy of the researcher's security against diversion control.
Some States may have their own registration requirements for Schedule I substances above and beyond the Federal requirements. Each researcher must check his or her own State authorities to see if other regulatory requirements need to be met. Given the small amounts of research material used by researchers in comparison to the additional regulatory burden and time delays, many researchers have been discouraged from pursuing research with these substances. Indeed, one of the recommendations of the Institute of Medicine Report entitled The Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector (National Academy Press, Washington, DC 1995, pp. 168-171) was that the current regulatory system be modified to remove barriers to undertaking clinical research with controlled substances.
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