Pinch
Well-Known Member
Know your opponent..The FDA Press releases -
Other Recent Testimony
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility
FDA Office of Legislation
Web page created by mn
FDA-Hinchey-Rohrabacher Amendment.
Hinchey-Rohrabacher Amendment Squashed in Congress; Yet Another Victory in Drug Policy, Proclaims Drug Free America Foundation
6/29/2006 1100 AM
To: National Desk
Contact: Lana Beck of the Drug Free America Foundation, 727-828-0211 or 727-403-7571
ST. PETERSBURG, Fla., June 29 /U.S. Newswire/ -- The Hinchey- Rohrabacher amendment would have prohibited the U.S. Department of Justice (including the DEA) from allocating funds to enforce federal drug laws in states that have legalized marijuana for so- called medical purposes. This amendment was soundly defeated in Congress by a vote of 259 to 163.
Despite the drug legalizers' dogged efforts to influence Congress, they failed. Although the pro-drug lobby touts biased polls that create an illusion that the majority of people are for marijuana as so-called medicine, the facts show that our legislators listen to their constituents and not the drug pushers. Legislators wisely considered the scientific evidence that dispels claims of marijuana being a legitimate medicine.
"This victory indicates an end to the medical marijuana scam," says Calvina Fay, Executive Director of Drug Free America Foundation, Inc. "Last year in the Raich v. Gonzales Supreme Court Case, the justices ruled in our favor against smoked marijuana as medicine. Then on April 20, 2006, the Food and Drug Administration (FDA) issued a statement concluding that they continue to support marijuana's placement as a Schedule I drug and agree that there is sound evidence that smoked marijuana is harmful. This reaffirms that medicine by popular vote is a dangerous process that bypasses the FDA, reduces consumer protections and jeopardizes sick patients."
Drug Free America Foundation is dedicated to fighting drug use, drug addiction and drug trafficking and to promoting effective, sound drug policies, education and prevention. It is equally committed to exposing and refuting the drug legalization advocates and their deceptive tactics.
If you would like to set up an interview regarding this issue with Calvina Fay or several other drug policy and prevention experts, please contact Lana Beck, Director of Communications, at 727-828-0211 or 727-403-7571.
Content Distribution & Promotion
/© 2006 U.S. Newswire 202-347-2770/
************************************************** ******
FOR IMMEDIATE RELEASE
April 20, 2006
Media Inquiries:
FDA Press Office, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine
Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor's recommendation, even though it is not an approved drug.
Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.
FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.
A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.
RSS Feed for FDA News Releases
Get free weekly updates about FDA press releases, recalls, speeches, testimony and more.
Media Contacts | FDA News Page
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility
FDA Website Management Staff
************************************************** *****
Testimony by
Robert J. Meyer, M.D.
Director
Office of Drug Evaluation II
Center for Drug Evaluation and Research
Food and Drug Administration
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
before the
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Committee on Government Reform
House of Representatives
April 1, 2004
INTRODUCTION
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am Dr. Robert Meyer, Director of the Office of Drug Evaluation II at the Food and Drug Administration’s (FDA or the Agency), Center for Drug Evaluation and Research (CDER). I am pleased to be here today with my colleague, Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA). FDA appreciates the opportunity to discuss the need for a science-based approach to evaluating the merits of marijuana for medicinal purposes.
In my testimony today, I will first describe the FDA drug approval process. Second, I will clarify FDA’s role in facilitating the objective evaluation of the potential merits of cannabinoids for medical uses as well as FDA’s role with respect to enforcement efforts relating to Schedule I Controlled Substances such as marijuana.
... text left out.. https://releases.usnewswire.com/printing.asp?id=68509
FDA has not approved marijuana for medical use in the United States. Despite its status as an unapproved new drug, there has been considerable interest in its use for the treatment of a number of conditions, including glaucoma, AIDS wasting, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and chemotherapy-induced nausea. Under the Controlled Substances Act (CSA) Congress listed marijuana in Schedule I. Schedule I substances have a very high potential for abuse, no accepted medical use in the United States, and lack accepted safety data for use under medical supervision. Schedule I substances can still be the subject of an IND; however, the conditions for its use are more restrictive.
Pursuant to the FD&C Act, FDA is responsible for the approval and marketing of drugs for medical use, including controlled substances. DEA is the lead Federal agency responsible for regulating controlled substances and enforcing the CSA. The CSA separates controlled substances into five schedules, depending upon their approved medical use and abuse potential. Unlike Schedule I controlled substances, Schedule II substances are approved for medical use, although they also have a very high potential for abuse. Schedules III, IV, and V include those controlled substances that have been approved for medical use, but whose potential for abuse is diminished.
FDA’s Office of Criminal Investigations (OCI) is responsible for managing and conducting the Agency’s criminal investigations. As a part of its duties, OCI has worked closely with DEA on a number of criminal investigations involving the illegal sale, use, and diversion of controlled substances including controlled substances sold over the Internet. OCI’s close working relationship with DEA and local law enforcement agencies has led to many successful criminal cases involving controlled substances. FDA cooperates with DEA and other state and Federal agencies. OCI is often requested by these entities to provide assistance. Both OCI and DEA have worked together in the past to utilize the full range of regulatory and administrative tools available to them to pursue cases involving controlled substances. However, the primary responsibility for enforcing the CSA resides with DEA, and, FDA generally defers to DEA on criminal enforcement efforts related to Schedule I controlled substances. The criminal penalties related to Schedule I controlled substances are far greater under the CSA than those available under the FD&C Act for the distribution of an unapproved new drug.
The Department of Health and Human Services (HHS) and FDA support the medical research community who intend to study marijuana in scientifically valid investigations and well-controlled clinical trials, in-line with the FDA’s drug approval process. HHS and FDA recognize the need for objective evaluations of the potential merits of cannabinoids for medical uses. If the scientific community discovers a positive benefit, HHS also recognizes the need to stimulate development of alternative, safer dosage forms. In February 1997, an NIH-sponsored workshop analyzed available scientific information and concluded that “in order to evaluate various hypotheses concerning the potential utility of marijuana in various therapeutic areas, more and better studies would be needed.”
In March 1999, the Institute of Medicine (IOM) issued a detailed report that supports the absolute need for evidence-based research into the effects of marijuana and cannabinoid components of marijuana, for patients with specific disease conditions. The IOM report also emphasized that smoked marijuana is a crude drug delivery system that exposes patients to a significant number of harmful substances and that “if there is any future of marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.” As such, the IOM recommended that clinical trials should be conducted with the goal of developing safe delivery systems.
In May 1999, HHS released “Guidance on Procedures for the Provision of Marijuana for Medical Research,” a document intended to provide the medical research community who intend to study marijuana in scientifically valid investigations and well-controlled clinical trials on HHS procedures for providing research-grade marijuana to sponsors. The HHS guidance is intended to facilitate the research needed to evaluate pending public health questions regarding marijuana by making research-grade marijuana available for well-designed studies on a cost-reimbursable basis. The focus of this HHS program is the support of quality research for the development of clinically meaningful data regarding marijuana. An appropriate scientific study of a drug requires, among other things, that the drug used in the research must have a consistent and predictable potency, must be free of contamination, and must be available in sufficient amounts to support the needs of the study. NIDA allocates resources to cultivate a grade of marijuana that is suitable for research purposes. The HHS Guidance outlines the procedures for obtaining research-grade marijuana including: 1) the researcher must make an inquiry to NIDA to determine the availability and costs of marijuana, and NIDA has to determine that marijuana is available to support the study; 2) researchers who propose to conduct investigations in humans must proceed through the FDA process for filing an IND application: and 3) all researchers must obtain from DEA registration to conduct research using a Schedule I controlled substance.
FDA regulates smoked marijuana, a botanical product, when it is being investigated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as a drug, under the FD&C Act. Botanicals include herbal products made from leaves, as well as products made from roots, stems, seeds, pollen or any other part of a plant. Botanical products pose some issues that are unique to this class of product, including the problem of lot-to-lot consistency. These unpurified products, which may be either from a single plant source or from a combination of different plant substances, often exert their reported effects through mechanisms that are either unknown or undefined. For these reasons, the exact chemical nature of these products may not be known. In addition, issues of strength, potency, shelf life, dosing and toxicity monitoring need to be addressed. If a product varies greatly, as can occur with botanicals, it is critical to obtain lot-to-lot product consistency. Without this it is difficult to determine if the product is causing the change in a patient's condition, or the change is related to some other factor. Because of the problems associated with obtaining lot-to-lot consistency with botanical marijuana, it is not surprising that IOM recommended that clinical trials should be conducted with the goal of developing safe delivery systems.
HHS performed a scientific and medical evaluation of marijuana in 2001 and concluded with a recommendation to DEA that marijuana should remain in Schedule I pursuant to section 201(b) of the CSA. HHS’s scientific and medical evaluation and scheduling recommendation can be found at Volume 66, Federal Register page 20038 (April 18, 2001). After receiving an HHS evaluation and recommendation, DEA is responsible for scheduling substances and as noted previously, has primary responsibility for the regulation and distribution of Schedule I substances.
FDA Approval of Safer Dosage Forms of Cannabinoids
FDA has approved two drugs, Marinol and Cesamet, for therapeutic uses in the U.S., which contain active ingredients that are present in botanical marijuana. On May 31, 1985, FDA approved Marinol Capsules, manufactured by Unimed, for nausea and vomiting associated with cancer chemotherapy inpatients that had failed to respond adequately to conventional antiemetic treatments. Marinol Capsules include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol or THC, which is considered the psychoactive component of marijuana. On December 22, 1992, FDA approved Marinol Capsules for the treatment of anorexia associated with weight loss in patients with AIDS. Although FDA approved Cesamet Capsules for the treatment of nausea and vomiting associated with chemotherapy on December 26, 1985, this product was never marketed in the U.S. Cesamet Capsules contain nabilone as the active ingredient, a synthetic cannabinoid. Nabilone is not naturally occurring and not derived from marijuana, as is THC.
These products have been through FDA’s rigorous approval process and have been determined to be safe and effective for their respective indications. It is only through the FDA drug approval process that solid clinical data can be obtained and a scientifically based assessment of the risks and benefits of an investigational drug is made. Upon FDA approval for marketing, consumers who need the medication can have confidence that the approved medication will be safe and effective.
CONCLUSION
Having access to a drug or medical treatment, without knowing how to use it or even if it is effective, does not benefit anyone. Simply having access, without having safety, efficacy, and adequate use information does not help patients. FDA has and will continue to use its IND and other expanded access programs to provide patients freedom to choose investigational medical treatments while reasonably ensuring safety, informed choice, and systematic data collection that allows us to review drug applications.
FDA will continue to be receptive to sound, scientifically based research into the medicinal uses of botanical marijuana and other cannabinoids. FDA will continue to facilitate the work of manufacturers interested in bringing to the market safe and effective products.
I would like to thank the Subcommittee again for the opportunity to testify today on this important issue. I would be happy, at this time, to answer any questions Members of the Subcommittee may have.
__________________
Other Recent Testimony
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility
FDA Office of Legislation
Web page created by mn
FDA-Hinchey-Rohrabacher Amendment.
Hinchey-Rohrabacher Amendment Squashed in Congress; Yet Another Victory in Drug Policy, Proclaims Drug Free America Foundation
6/29/2006 1100 AM
To: National Desk
Contact: Lana Beck of the Drug Free America Foundation, 727-828-0211 or 727-403-7571
ST. PETERSBURG, Fla., June 29 /U.S. Newswire/ -- The Hinchey- Rohrabacher amendment would have prohibited the U.S. Department of Justice (including the DEA) from allocating funds to enforce federal drug laws in states that have legalized marijuana for so- called medical purposes. This amendment was soundly defeated in Congress by a vote of 259 to 163.
Despite the drug legalizers' dogged efforts to influence Congress, they failed. Although the pro-drug lobby touts biased polls that create an illusion that the majority of people are for marijuana as so-called medicine, the facts show that our legislators listen to their constituents and not the drug pushers. Legislators wisely considered the scientific evidence that dispels claims of marijuana being a legitimate medicine.
"This victory indicates an end to the medical marijuana scam," says Calvina Fay, Executive Director of Drug Free America Foundation, Inc. "Last year in the Raich v. Gonzales Supreme Court Case, the justices ruled in our favor against smoked marijuana as medicine. Then on April 20, 2006, the Food and Drug Administration (FDA) issued a statement concluding that they continue to support marijuana's placement as a Schedule I drug and agree that there is sound evidence that smoked marijuana is harmful. This reaffirms that medicine by popular vote is a dangerous process that bypasses the FDA, reduces consumer protections and jeopardizes sick patients."
Drug Free America Foundation is dedicated to fighting drug use, drug addiction and drug trafficking and to promoting effective, sound drug policies, education and prevention. It is equally committed to exposing and refuting the drug legalization advocates and their deceptive tactics.
If you would like to set up an interview regarding this issue with Calvina Fay or several other drug policy and prevention experts, please contact Lana Beck, Director of Communications, at 727-828-0211 or 727-403-7571.
Content Distribution & Promotion
/© 2006 U.S. Newswire 202-347-2770/
************************************************** ******
FOR IMMEDIATE RELEASE
April 20, 2006
Media Inquiries:
FDA Press Office, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine
Claims have been advanced asserting smoked marijuana has a value in treating various medical conditions. Some have argued that herbal marijuana is a safe and effective medication and that it should be made available to people who suffer from a number of ailments upon a doctor's recommendation, even though it is not an approved drug.
Marijuana is listed in schedule I of the Controlled Substances Act (CSA), the most restrictive schedule. The Drug Enforcement Administration (DEA), which administers the CSA, continues to support that placement and FDA concurred because marijuana met the three criteria for placement in Schedule I under 21 U.S.C. 812(b)(1) (e.g., marijuana has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and has a lack of accepted safety for use under medical supervision). Furthermore, there is currently sound evidence that smoked marijuana is harmful. A past evaluation by several Department of Health and Human Services (HHS) agencies, including the Food and Drug Administration (FDA), Substance Abuse and Mental Health Services Administration (SAMHSA) and National Institute for Drug Abuse (NIDA), concluded that no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use. There are alternative FDA-approved medications in existence for treatment of many of the proposed uses of smoked marijuana.
FDA is the sole Federal agency that approves drug products as safe and effective for intended indications. The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in this country. FDA's drug approval process requires well-controlled clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions. If a drug product is to be marketed, disciplined, systematic, scientifically conducted trials are the best means to obtain data to ensure that drug is safe and effective when used as indicated. Efforts that seek to bypass the FDA drug approval process would not serve the interests of public health because they might expose patients to unsafe and ineffective drug products. FDA has not approved smoked marijuana for any condition or disease indication.
A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor's recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.
RSS Feed for FDA News Releases
Get free weekly updates about FDA press releases, recalls, speeches, testimony and more.
Media Contacts | FDA News Page
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility
FDA Website Management Staff
************************************************** *****
Testimony by
Robert J. Meyer, M.D.
Director
Office of Drug Evaluation II
Center for Drug Evaluation and Research
Food and Drug Administration
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
before the
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
Committee on Government Reform
House of Representatives
April 1, 2004
INTRODUCTION
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am Dr. Robert Meyer, Director of the Office of Drug Evaluation II at the Food and Drug Administration’s (FDA or the Agency), Center for Drug Evaluation and Research (CDER). I am pleased to be here today with my colleague, Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA). FDA appreciates the opportunity to discuss the need for a science-based approach to evaluating the merits of marijuana for medicinal purposes.
In my testimony today, I will first describe the FDA drug approval process. Second, I will clarify FDA’s role in facilitating the objective evaluation of the potential merits of cannabinoids for medical uses as well as FDA’s role with respect to enforcement efforts relating to Schedule I Controlled Substances such as marijuana.
... text left out.. https://releases.usnewswire.com/printing.asp?id=68509
FDA has not approved marijuana for medical use in the United States. Despite its status as an unapproved new drug, there has been considerable interest in its use for the treatment of a number of conditions, including glaucoma, AIDS wasting, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and chemotherapy-induced nausea. Under the Controlled Substances Act (CSA) Congress listed marijuana in Schedule I. Schedule I substances have a very high potential for abuse, no accepted medical use in the United States, and lack accepted safety data for use under medical supervision. Schedule I substances can still be the subject of an IND; however, the conditions for its use are more restrictive.
Pursuant to the FD&C Act, FDA is responsible for the approval and marketing of drugs for medical use, including controlled substances. DEA is the lead Federal agency responsible for regulating controlled substances and enforcing the CSA. The CSA separates controlled substances into five schedules, depending upon their approved medical use and abuse potential. Unlike Schedule I controlled substances, Schedule II substances are approved for medical use, although they also have a very high potential for abuse. Schedules III, IV, and V include those controlled substances that have been approved for medical use, but whose potential for abuse is diminished.
FDA’s Office of Criminal Investigations (OCI) is responsible for managing and conducting the Agency’s criminal investigations. As a part of its duties, OCI has worked closely with DEA on a number of criminal investigations involving the illegal sale, use, and diversion of controlled substances including controlled substances sold over the Internet. OCI’s close working relationship with DEA and local law enforcement agencies has led to many successful criminal cases involving controlled substances. FDA cooperates with DEA and other state and Federal agencies. OCI is often requested by these entities to provide assistance. Both OCI and DEA have worked together in the past to utilize the full range of regulatory and administrative tools available to them to pursue cases involving controlled substances. However, the primary responsibility for enforcing the CSA resides with DEA, and, FDA generally defers to DEA on criminal enforcement efforts related to Schedule I controlled substances. The criminal penalties related to Schedule I controlled substances are far greater under the CSA than those available under the FD&C Act for the distribution of an unapproved new drug.
The Department of Health and Human Services (HHS) and FDA support the medical research community who intend to study marijuana in scientifically valid investigations and well-controlled clinical trials, in-line with the FDA’s drug approval process. HHS and FDA recognize the need for objective evaluations of the potential merits of cannabinoids for medical uses. If the scientific community discovers a positive benefit, HHS also recognizes the need to stimulate development of alternative, safer dosage forms. In February 1997, an NIH-sponsored workshop analyzed available scientific information and concluded that “in order to evaluate various hypotheses concerning the potential utility of marijuana in various therapeutic areas, more and better studies would be needed.”
In March 1999, the Institute of Medicine (IOM) issued a detailed report that supports the absolute need for evidence-based research into the effects of marijuana and cannabinoid components of marijuana, for patients with specific disease conditions. The IOM report also emphasized that smoked marijuana is a crude drug delivery system that exposes patients to a significant number of harmful substances and that “if there is any future of marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.” As such, the IOM recommended that clinical trials should be conducted with the goal of developing safe delivery systems.
In May 1999, HHS released “Guidance on Procedures for the Provision of Marijuana for Medical Research,” a document intended to provide the medical research community who intend to study marijuana in scientifically valid investigations and well-controlled clinical trials on HHS procedures for providing research-grade marijuana to sponsors. The HHS guidance is intended to facilitate the research needed to evaluate pending public health questions regarding marijuana by making research-grade marijuana available for well-designed studies on a cost-reimbursable basis. The focus of this HHS program is the support of quality research for the development of clinically meaningful data regarding marijuana. An appropriate scientific study of a drug requires, among other things, that the drug used in the research must have a consistent and predictable potency, must be free of contamination, and must be available in sufficient amounts to support the needs of the study. NIDA allocates resources to cultivate a grade of marijuana that is suitable for research purposes. The HHS Guidance outlines the procedures for obtaining research-grade marijuana including: 1) the researcher must make an inquiry to NIDA to determine the availability and costs of marijuana, and NIDA has to determine that marijuana is available to support the study; 2) researchers who propose to conduct investigations in humans must proceed through the FDA process for filing an IND application: and 3) all researchers must obtain from DEA registration to conduct research using a Schedule I controlled substance.
FDA regulates smoked marijuana, a botanical product, when it is being investigated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals, as a drug, under the FD&C Act. Botanicals include herbal products made from leaves, as well as products made from roots, stems, seeds, pollen or any other part of a plant. Botanical products pose some issues that are unique to this class of product, including the problem of lot-to-lot consistency. These unpurified products, which may be either from a single plant source or from a combination of different plant substances, often exert their reported effects through mechanisms that are either unknown or undefined. For these reasons, the exact chemical nature of these products may not be known. In addition, issues of strength, potency, shelf life, dosing and toxicity monitoring need to be addressed. If a product varies greatly, as can occur with botanicals, it is critical to obtain lot-to-lot product consistency. Without this it is difficult to determine if the product is causing the change in a patient's condition, or the change is related to some other factor. Because of the problems associated with obtaining lot-to-lot consistency with botanical marijuana, it is not surprising that IOM recommended that clinical trials should be conducted with the goal of developing safe delivery systems.
HHS performed a scientific and medical evaluation of marijuana in 2001 and concluded with a recommendation to DEA that marijuana should remain in Schedule I pursuant to section 201(b) of the CSA. HHS’s scientific and medical evaluation and scheduling recommendation can be found at Volume 66, Federal Register page 20038 (April 18, 2001). After receiving an HHS evaluation and recommendation, DEA is responsible for scheduling substances and as noted previously, has primary responsibility for the regulation and distribution of Schedule I substances.
FDA Approval of Safer Dosage Forms of Cannabinoids
FDA has approved two drugs, Marinol and Cesamet, for therapeutic uses in the U.S., which contain active ingredients that are present in botanical marijuana. On May 31, 1985, FDA approved Marinol Capsules, manufactured by Unimed, for nausea and vomiting associated with cancer chemotherapy inpatients that had failed to respond adequately to conventional antiemetic treatments. Marinol Capsules include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol or THC, which is considered the psychoactive component of marijuana. On December 22, 1992, FDA approved Marinol Capsules for the treatment of anorexia associated with weight loss in patients with AIDS. Although FDA approved Cesamet Capsules for the treatment of nausea and vomiting associated with chemotherapy on December 26, 1985, this product was never marketed in the U.S. Cesamet Capsules contain nabilone as the active ingredient, a synthetic cannabinoid. Nabilone is not naturally occurring and not derived from marijuana, as is THC.
These products have been through FDA’s rigorous approval process and have been determined to be safe and effective for their respective indications. It is only through the FDA drug approval process that solid clinical data can be obtained and a scientifically based assessment of the risks and benefits of an investigational drug is made. Upon FDA approval for marketing, consumers who need the medication can have confidence that the approved medication will be safe and effective.
CONCLUSION
Having access to a drug or medical treatment, without knowing how to use it or even if it is effective, does not benefit anyone. Simply having access, without having safety, efficacy, and adequate use information does not help patients. FDA has and will continue to use its IND and other expanded access programs to provide patients freedom to choose investigational medical treatments while reasonably ensuring safety, informed choice, and systematic data collection that allows us to review drug applications.
FDA will continue to be receptive to sound, scientifically based research into the medicinal uses of botanical marijuana and other cannabinoids. FDA will continue to facilitate the work of manufacturers interested in bringing to the market safe and effective products.
I would like to thank the Subcommittee again for the opportunity to testify today on this important issue. I would be happy, at this time, to answer any questions Members of the Subcommittee may have.
__________________
