In late February 2015, FDA issued several warning letters to
firms that market unapproved drugs for the diagnosis, cure, mitigation,
treatment, or prevention of diseases. Some of these firms claim that their
products contain cannabidiol (CBD). FDA has tested those products and, in some
of them, did not detect any CBD. It is important to note that these products
are not approved by FDA for the diagnosis, cure, mitigation, treatment, or
prevention of any disease, and often they do not even contain the ingredients
found on the label. Consumers should beware purchasing and using any such
products.
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm435591.htm
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Looking for Treatment
The FDA understands that caregivers and patients are looking
for treatment options for unmet medical needs. In some instances, patients or
their caregivers are turning to marijuana in an attempt to treat conditions
such as seizures and chemotherapy-induced nausea.
Untested Drugs can have Unknown Consequences
Over the last few decades, there has been significant
interest in the potential utility of marijuana for a variety of medical
conditions, including those that already have FDA-approved therapies.
More recently, several states have also passed laws that
remove state restrictions on health care professionals using marijuana as a
medical treatment for a variety of conditions. A number of other states are
considering similar legislation regarding the use of marijuana in medical
settings.
FDA’s Role in the Drug Approval Process
The FDA has not approved marijuana as a safe and effective
drug for any indication. The agency has, however, approved two drugs containing
a synthetic version of a substance that is present in the marijuana plant and
one other drug containing a synthetic substance that acts similarly to
compounds from marijuana but is not present in marijuana. Although the FDA has
not approved any drug product containing or derived from botanical marijuana,
the FDA is aware that there is considerable interest in its use to attempt to
treat a number of medical conditions, including, for example, glaucoma, AIDS
wasting syndrome, neuropathic pain, cancer, multiple sclerosis,
chemotherapy-induced nausea, and certain seizure disorders.
Before conducting testing in humans of a drug that has not
been approved by the FDA, an investigator submits an investigational new drug
(IND) application, which is reviewed by the FDA. An IND includes protocols
describing proposed studies, the qualifications of the investigators who will
conduct the clinical studies, and assurances of informed consent and protection
of the rights, safety, and welfare of the human subjects. The FDA reviews the
IND to ensure that the proposed studies, generally referred to as clinical
trials, do not place human subjects at unreasonable risk of harm. The FDA also
verifies that there are adequate assurances of informed consent and human
subject protection.
The FDA’s role in the regulation of drugs, including
marijuana and marijuana-derived products, also includes review of applications
to market drugs to determine whether proposed drug products are safe and
effective for their intended indications. The FDA’s drug approval process
requires that clinical trials be designed and conducted in a way that provide
the agency with the necessary scientific data upon which the FDA can make its
approval decisions. Without this review, the FDA cannot determine whether a
drug product is safe and effective. It also cannot ensure that a drug product
meets appropriate quality standards. For certain drugs that have not been
approved by the FDA, such as marijuana, the lack of FDA approval and oversight
means that the purity and potency of the drug may vary considerably.
The FDA’s expanded access provisions are designed to
facilitate the availability of investigational products to patients with
serious diseases or conditions when there is no comparable or satisfactory
alternative therapy available, either because the patients have exhausted
treatment with or are intolerant of approved therapies, or when the patients
are not eligible for an ongoing clinical trial.
As with other drugs that are not approved by the FDA, the
agency works closely with the medical and patient communities, and our federal
partners when necessary, to allow access to experimental treatments through the
expanded access provisions described in the FDA’s statute and regulations.
https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421163.htm
Courtesy of our pharmacist
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