Re: What happen to the dog studies?

[Guest guest]

what is this? I don't get it, and I am a dog lover so I am trying

not to be irritated by it?

Jenna

>

> > From: " Lana Transue " <lanadearest@h...>

> > saxony01@y...

> > Subject: What happen to the dog studies?

> > Date: Mon, 28 Nov 2005 00:27:25 -0800

> >

> > After trying to explain to a friend today why

> > marijauna is illeagal, I

> > decided to see what the FDA has to say about it. I

> > found it very interesting

> > that the first step in an approval process is to do

> > a study on dogs. Now I

> > am not saying that they should use dogs for the

> > implant research but it is

> > suppose to be the FIRST STEP of the approval

> > proceedure. What happen to the

> > dog studies on the implants? I know how bad the

> > original dog studies were,

> > but what happen to the studies being done on dogs

> > before th current approval

> > applications were submitted? Lana

> >

> > FDA reviews the IND for assurance that the proposed

> > studies, generally

> > referred to as clinical trials, do not place human

> > subjects at unreasonable

> > risk of harm. FDA also verifies that there are

> > adequate assurances of

> > informed consent and human subject protection. At

> > that point the first of

> > three phases of study in humans can begin.

> >

> > What about the enconclusive tests that have been

> > done on secondary exposure?

> >

> >

> > FDA Home Page | Search FDA Site | FDA A-Z Index |

> > Contact FDA

> >

> >

> >

> > Testimony by

> > 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.

> > 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.

> >

> > FDA APPROVAL PROCESS

> >

> > FDA's primary mission for over 90 years has been to

> > promote and protect the

> > public health, under the authority of the Federal

> > Food, Drug, and Cosmetic

> > (FD & C) Act and the Public Health Service Act. These

> > statutes were enacted

> > and amended, in part, in response to public health

> > tragedies resulting from

> > the sale to, and use by, an unsuspecting public of

> > unsafe and ineffective

> > products sold as medicines and medical devices. The

> > FD & C Act requires that

> > new drugs be shown to be safe and effective before

> > being marketed in this

> > country.

> >

> > The single most important public health provision in

> > these statutes is the

> > requirement that a person wishing to sell to the

> > public a product to

> > prevent, cure or mitigate illness or injury must

> > first prove that such

> > product is safe, and actually does what the vendor

> > claims it does. This

> > statutory provision affords patients the most

> > effective protection against

> > untested and unproven products.

> >

> > A new drug or biologic (referred to in this

> > statement as a drug) may not be

> > distributed in interstate commerce (except for

> > clinical studies under an

> > investigational new drug application) until a

> > sponsor, usually the drug

> > manufacturer, has submitted and FDA has approved a

> > new drug application

> > (NDA) or a biologics license application (BLA) for

> > the product. For

> > approval, an NDA or BLA must contain sufficient

> > scientific evidence

> > demonstrating the safety and effectiveness of the

> > drug for its intended

> > uses.

> >

> > The evidence of safety and effectiveness usually is

> > obtained through

> > controlled clinical trials. The disciplined,

> > systematic, scientific conduct

> > of such trials is the most effective and certain

> > means of obtaining the data

> > that document safety and efficacy of a drug and how

> > to use the new product

> > so that it will have the most beneficial effect.

> >

> > A. INVESTIGATIONAL NEW DRUG APPLICATION PROCESS

> > The first step a sponsor usually must take to obtain

> > approval for a new drug

> > is to test the drug in animals for toxicity. The

> > sponsor then takes that

> > animal testing data, along with additional

> > information about the drug's

> > composition and manufacturing, and develops a plan

> > for testing the drug in

> > humans. The sponsor submits these data, along with

> > proposed studies, the

> > qualifications of the investigators who will conduct

> > the clinical studies,

> > and assurances of informed consent and protection of

> > the rights and safety

> > of the human subjects, to FDA in the form of an

> > investigational new drug

> > application (IND).

> >

> > FDA reviews the IND for assurance that the proposed

> > studies, generally

> > referred to as clinical trials, do not place human

> > subjects at unreasonable

> > risk of harm. FDA also verifies that there are

> > adequate assurances of

> > informed consent and human subject protection. At

> > that point the first of

> > three phases of study in humans can begin. Phase I

> > studies primarily focus

> > on the safety of the drug in humans. Phase I studies

> > carefully assess how to

> > safely administer and dose the drug with an emphasis

> > on evaluation of the

> > toxic manifestations of the therapy, how the body

> > distributes and degrades

> > the drug, and how side effects relate to dose. Phase

> > I studies typically

> > include fewer than 100 healthy volunteers or

> > subjects.

> >

> > Phase II studies are clinical studies to explore the

> > effectiveness of the

> > drug for a particular indication over a range of

> > doses and to determine

> > common short-term side effects. Phase II studies

> > typically involve a few

> > hundred subjects. Once Phase II studies are

> > successfully completed, the

> > drug's sponsor has learned much about the drug's

> > appropriate dosing and its

> > apparent safety and effectiveness. The next step is

> > to conduct Phase III

> > studies involving up to several thousand subjects.

> > These studies establish

> > efficacy for a particular indication, examine

> > additional uses, may provide

> > further safety data including long-term experience,

> > and consider additional

> > population subsets, dose response, etc. FDA strongly

> > encourages sponsors to

> > work closely with the Agency in planning definitive

> > Phase III clinical

> > trials to help assure that the trials are designed

> > to have the greatest

> > likelihood of producing results sufficient to

> > provide adequate data and

> > permit the Agency to make appropriate decisions

> > about the safety and

> > efficacy of the product.

> >

> > Once Phase III trials are completed, the sponsor

> > submits the results of all

> > the relevant testing to FDA in the form of an NDA.

> > FDA's medical officers,

> > chemists, statisticians, and pharmacologists review

> > the application to

> > determine if the sponsor's data in fact show that

> > the drug is both safe and

> > effective. The drug's manufacturing process is

> > evaluated to confirm that the

> > product can be produced consistently with high

> > quality. It is common to

> > allow subjects in Phase II and III studies to

> > continue on a therapy if it

> > seems to be providing benefit. This practice

> > provides long-term safety

> > information at an early stage in this process. At

> > present, there are

> > literally thousands of clinical trials ongoing,

> > involving hundreds of

> > thousands of subjects. There are over 15,000 active

> > INDs for drugs,

> > therapeutic biologics, and biologics filed with the

> > Agency.

> >

> > Results of controlled clinical trials are the basis

> > of evidence-based

> > medicine. These allow physicians and patients to use

> > therapies with a clear

> > understanding of their benefits and risks and, in

> > some cases, a basis for

> > strong public health recommendations for treatments.

> >

> > Clinical trials also have saved us from unwanted

> > public health consequences.

> > For example, when azidothymidine (AZT) was the only

> > approved AIDS treatment,

> > dideoxycytidine (ddC) was made available under

> > treatment-IND for the several

> > years while clinical trials were underway. These

> > trials were to assess

> > whether ddC was superior to AZT or if it was

> > effective for patients

> > intolerant of AZT. Although the product, ddC, could

> > cause permanent,

> > sometimes severe nerve damage, there was great

> > demand for early access to

> > the product. It was even manufactured by sources

> > other than the company

> > (probably by amateur chemists) and this " bathtub "

> > ddC was made available

> > through buyers clubs when the demand exceeded the

> > sponsor's supply. FDA

> > acted with the sponsor, the buyers clubs, patient

> > advocates, and

> > investigators to make more of the drug available and

> > get the illicit, poorly

> > manufactured product off the market.

> >

> > What did the ddC clinical trials show? In a

> > head-to-head comparison versus

> > AZT as initial therapy, an independent data safety

> > monitoring board stopped

> > the trial early because the death rate in the ddC

> > group was at least twice

> > higher than in the AZT group. For patients

> > intolerant to AZT, a clinical

> > trial compared switching to ddC versus

> > dideoxyinosine (ddI). In this study

> > the trend was that ddC had superior survival to ddI.

> > Later studies showed

> > that ddC in combination with AZT had superior

> > survival to AZT alone. Each of

> > these studies involved hundreds of patients and was

> > essential to determining

> > where ddC improved survival and where it did not.

> > Although some of the early

> > access uses were later found to be poor choices,

> > physicians considered it

> > reasonable at the time to provide the drug while the

> > question was still

> > being answered. The important point is that patients

> > are only well served by

> > early access when the controlled clinical trials

> > proceed in parallel with

> > early access.

> >

> > A second example that illustrates the importance of

> > conducting clinical

> > trials is the recently announced results of the

> > Women's Health Initiative

> > (WHI) study of estrogen and progesterone in treating

> > post-menopausal women

> > conducted by the National Institutes of Health. This

> > large (more than 16,000

> > women), scientifically rigorous clinical trial was

> > done to confirm the

> > widely held belief that estrogen/progesterone

> > therapy in post-menopausal

> > women would significantly reduce the risk of

> > cardiovascular events, such as

> > heart attacks and strokes. There was also some hope

> > that this

> > post-menopausal therapy might lessen the onset of

> > Alzheimer's disease. These

> > widely held beliefs were based on scientific

> > evidence that was not from

> > clinical trials, such as epidemiology. On the

> > strengths of these beliefs,

> > post-menopausal hormone therapy was very widely used

> > and growing in

> > popularity.

> >

> > The WHI trial or post-menopausal

> > estrogen/progesterone preceded but was

> > stopped early due to an excess of harm in women

> > taking these drugs compared

> > to placebo. Surprisingly and importantly, women

> > given the active drugs were

> > more likely to suffer heart attacks and strokes and

> > appeared to be more

> > likely to develop dementia. This study not only

> > failed to prove the widely

> > held notion that this therapy was good for

> > preventing these types of

> > occurrences, but actually confirmed harm. These

> > important results have led

> > to significant changes in the use of post-menopausal

> > hormones.

> >

> > FDA sometimes uncovers individuals who do not comply

> > with statutory and

> > regulatory drug approval requirements. This puts

> > patients at risk of using

> > unproven products and also denies to all patients

> > the knowledge of whether

> > the untested therapies may actually work.

> > Distribution of unproven products

> > and subsequent widespread use combined with little

> > accountability or

> > liability reduces the incentive for manufacturers

> > and health care

> > practitioners to conduct studies of safety and

> > effectiveness. We constantly

> > work to find ways to make safe and effective

> > products available to patients

> > as quickly and efficiently as possible, consistent

> > with the protections

> > established in the law. It is essential to preserve

> > the system of controlled

> > clinical trials that provides the information

> > necessary to make the final

> > determination on the safety and effectiveness of

> > unapproved products. The

> > two concepts, the protection of public health and

> > making available

> > treatments for individuals, can and must co-exist.

> >

> > B. HUMAN SUBJECT PROTECTION

> > The FD & C Act and its implementing regulations are

> > one part of a complex

> > system of safeguards designed to protect human

> > subjects. Each participant in

> > a research effort --the company that sponsors the

> > research, the clinical

> > investigator who conducts the research, and the

> > Institutional Review Board

> > (IRB) is obliged to protect the interests of the

> > people who are taking part

> > in the experiments. FDA's responsibility is to see

> > that the safeguards are

> > met. FDA monitors the activities of research

> > sponsors, researchers, IRBs and

> > others involved in the trial. We take very seriously

> > our role to protect

> > people enrolled in clinical trials.

> >

> > The sponsors of research --usually, manufacturers or

> > academic bodies, but

> > sometimes individual physicians --must select

> > well?qualified clinical

> > investigators, design scientifically-sound

> > protocols, make sure that the

> > research is properly conducted, and make certain

> > that the clinical

> > investigators conduct the research in compliance

> > with all pertinent

> > regulations, including requirements for obtaining

> > informed consent and

> > review by an IRB. The primary regulatory obligations

> > of the clinical

> > investigator are to: 1) conduct or supervise the

> > study; 2) conduct the study

> > according to the approved protocol or research plan;

> > 3) ensure that the

> > study is reviewed and approved by an IRB that is

> > constituted and functioning

> > according to FDA and other Federal requirements; 4)

> > obtain informed consent;

> > 5) maintain adequate and accurate records of study

> > observations (including

> > adverse reactions); 6) administer the drug only to

> > subjects under the

> > investigator's personal supervision or under the

> > supervision of a

> > sub-investigator responsible to the investigator; 7)

> > report to the sponsor

> > adverse experiences that occur in the course of the

> > investigation; and 8)

> > promptly report to the IRB all unanticipated

> > problems involving risks to

> > humans or others.

> >

> > The core of FDA's informed consent regulations,

> > Title 21, Code of Federal

> > Regulations (CFR) Part 50, is that the clinical

> > investigator must generally

> > obtain the informed consent of a human subject or

> > his/her legally authorized

> > representative before any FDA?regulated research can

> > be conducted. The

> > researcher has to make sure that, whenever possible,

> > the study participants

> > fully understand the potential risks and benefits of

> > the experiment before

> > the experiment begins. The information provided must

> > be in a language

> > understandable to the subject, and must not require

> > the subject to waive any

> > legal rights, or release those conducting the study

> > from liability for

> > negligence. The clinical investigator must tell the

> > human subjects important

> > information about the study and its potential

> > consequences so that the

> > person can decide whether to be in the experiment.

> > The entire informed

> > consent process involves giving the subject all the

> > information concerning

> > the study that he or she would reasonably want to

> > know, ensuring that the

> > subject has comprehended this information, and

> > obtaining the subject's

> > written consent to participate.

> >

> > An IRB is a group (consisting of experts and lay

> > persons) formally

> > designated to review, approve the initiation of, and

> > periodically review the

> > progress of, research involving human subjects. The

> > primary function of IRBs

> > is to protect the rights and welfare of the people

> > who are in trials. FDA's

> > regulations, 21 CFR Part 56, contain the general

> > standards for the

> > composition, operation, and responsibility of an IRB

> > that reviews clinical

> > investigations submitted to FDA under sections

> > 505(i), and 520(g) of the

> > FD & C Act. IRBs must scrutinize and approve each of

> > the clinical trials that

> > are conducted on FDA-regulated products in this

> > country each year. IRBs must

> > develop and follow procedures for their initial and

> > continuing review of the

> > trials. Among other requirements, IRBs must make

> > sure that the risks to

> > subjects are minimized and do not outweigh the

> > anticipated study benefits,

> > that the selection of participants is equitable,

> > that there are adequate

> > plans to monitor data gathered in the trial and

> > provisions to protect the

> > privacy of subjects and the confidentiality of data.

> > The IRB has the

> > authority to approve, modify, or disapprove a

> > clinical trial. The IRB must

> > approve the informed consent form that will be used.

> > If the researchers fail

> > to adhere to IRB requirements, the IRB has the

> > authority and the

> > responsibility to take appropriate steps, which may

> > include termination of

> > the trial. The IRB is required to conduct continuing

> > review of ongoing

> > research at intervals appropriate to the degree of

> > risk, but not less than

> > once per year. It also has the authority to observe

> > or have a third party

> > observe the consent process and the research.

> >

> > IRBs are currently not required to register with FDA

> > nor inform FDA when

> > they begin reviewing studies. However, FDA performs

> > on-site inspections of

> > IRBs that review research involving products that

> > FDA regulates, including

> > IRBs in academic institutions and hospitals as well

> > as those independent

> > from where the research will be conducted. The

> > primary focus of FDA's IRB

> > Program is the protection of the rights and welfare

> > of research subjects,

> > rather than validating the data obtained from

> > research.

> >

> > Marijuana

> >

> > 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( 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

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>

[Guest guest]

Jenna,

The story behind all this would make you sick! . . .

Garbage handlers testified about disposing of hundreds

of dead test animals. . . .

It appears that DOW didn't admit to some of the

studies . . . Now, an organization must announce a

study before starting and report the study results . .

..

As if we could believe what they said to begin with!

Hugs,

Rogene

[Guest guest]

Um you just lit a fire under my behind! I know this sounds stupid,

but I can watch a movie when they murder a human but when a dog is

involved I cry and make my husband turn it off....oh boy..I am

curious but I just don't want to know anymore!! How HORRIBLE! I have

to go give my dog some kisses...

Jenna

>

> Jenna,

>

> The story behind all this would make you sick! . . .

>

> Garbage handlers testified about disposing of hundreds

> of dead test animals. . . .

>

> It appears that DOW didn't admit to some of the

> studies . . . Now, an organization must announce a

> study before starting and report the study results . .

> .

>

> As if we could believe what they said to begin with!

>

> Hugs,

>

> Rogene

>

[Guest guest]

My husband often says he thinks I cuddle our little poodle more than him!

(He is joking, I think!)

I love dogs, and can't stand to see them harmed.

> >

> > Jenna,

> >

> > The story behind all this would make you sick! . . .

> >

> > Garbage handlers testified about disposing of hundreds

> > of dead test animals. . . .

> >

> > It appears that DOW didn't admit to some of the

> > studies . . . Now, an organization must announce a

> > study before starting and report the study results . .

> > .

> >

> > As if we could believe what they said to begin with!

> >

> > Hugs,

> >

> > Rogene

> >

>