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  1. Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components. Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses. Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older. This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients. This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced. So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs. That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work. This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns. This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards. Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration. The FDA has taken several specific steps to support this research. We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds. Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied. Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today. The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits. Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
  2. Newsroom Press Announcements 2013201220112010 FDA News Release FDA approves first combination pill to treat hepatitis C For Immediate Release October 10, 2014 Release The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. “With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.” Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis. Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustain ed virologic response, or SVR), indicating that a participant’s HCV infection has been cured. In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants. The most common side effects reported in clinical trial participants were fatigue and headache. Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Harvoni was reviewed under th e FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness. Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ### Inquiries Media Stephanie Yao 301-796-0394 Consumers 888-INFO-FDA The Hemophilia Foundation of Michigan(HFM) provides this information as a service only. HFM does not endorse or re commend the products and/or services mentioned in the enclosed materials. They are for your information only. It is the choice of the consumer whether to act on any of the information provided. Always consult your healthcare provider before making treatment decisions. Trix
  3. The feds could actually soften their stance a little when it comes to weed. The Food and Drug Administration is reviewing the medical evidence surrounding the safety and effectiveness of marijuana, a process that could lead to the agency downgrading the drug's current status as a Schedule I drug, the most dangerous classification. FDA Press Officer Jeff Ventura described the review process, which is being completed at the request of the Drug Enforcement Agency, to The Huffington Post. "FDA conducts for Health and Human Services a scientific and medical analysis of the drug under consideration, which is currently ongoing," Ventura said. "HHS then recommends to DEA that the drug be placed in a given schedule. DEA considers HHS’ analysis, conducts its own assessment, and makes a final scheduling proposal in the form of a proposed rule." The FDA could not confirm how long the review process would take. The U.S. has five "schedules" for drugs or chemicals that can be used to make drugs. Schedule I is reserved for drugs that the DEA considers to have the highest potential for abuse and no "current accepted medical use." Marijuana has been classified as Schedule I for decades, along with other substances like heroin and LSD. Rescheduling marijuana would not make it legal, but a lower schedule could potentially ease restrictions on research into the drug and make banks less wary of offering financial services to state-legal marijuana businesses. It could also allow those businesses to make some traditional tax deductions. "While DEA is the lead federal agency responsible for regulating controlled substances and enforcing the Controlled Substances Act, FDA, working with NIDA, provides scientific recommendations about the appropriate controls for those substances," FDA Deputy Director Doug Throckmorton said Friday in testimony delivered during the House Committee on Oversight and Government Reform hearing. "To make these recommendations, FDA is responsible for preparing what's called an eight-factor analysis, which is a document that is used to assess how likely a drug is to be abused," Throckmorton said. Here are the eight factors the FDA will consider about marijuana when deciding which schedule it should go under, according to the CSA: Its actual or relative potential for abuse Scientific evidence of its pharmacological effect, if known The state of current scientific knowledge regarding the drug or other substance Its history and current pattern of abuse The scope, duration, and significance of abuse What, if any, risk there is to the public health Its psychic or physiological dependence liability Whether the substance is an immediate precursor of a substance already controlled under this subchapter A DEA spokeswoman told HuffPost that the agency was required to order the FDA to review marijuana's scheduling status because of two public citizens' petitions that asked the agency for a review. A change could put marijuana in the company of cocaine and methamphetamine, two other Schedule II drugs. This isn't the first time the DEA has asked the FDA to reconsider marijuana, Throckmorton said Friday. In 2001 and 2006, the DEA requested an analysis of the drug after receiving other public petitions requesting that the agency reschedule it. But both times, federal regulators determined that marijuana should remain a Schedule I substance. At the time, the FDA said there simply wasn't enough research about marijuana's efficacy in treating various ailments. Part of the lack of cannabis science in the U.S. has to do with the federal stranglehold on marijuana research. There's only one federally legal marijuana garden in the U.S., at the University of Mississippi. The National Institute on Drug Abuse oversees the operation, and it's the only source of marijuana for federally sanctioned studies on the drug. To date, NIDA has conducted about 30 studies on the potential benefits of marijuana. Since 2003, it has approved more than 500 grants for marijuana-related studies, with a marked upswing in recent years, according to McClatchy. In 2003, 22 grants totaling $6 million were approved for cannabis research, McClatchy reported. In 2012, that number had risen to 69 approved grants totaling more than $30 million. Federal authorities have long been accused of only funding marijuana research that focuses on the potential negative effects of the substance. The DEA has also been accused of not acting quickly enough when petitioned to reschedule marijuana, and for obstructing science around the drug. Meanwhile, a number of recent studies have added to the growing body of research showing the medical potential of cannabis. Purified forms may attack some forms of aggressive cancer. Studies have tied marijuana use to blood sugar control and slowing the spread of HIV. One study found that legalization of the plant for medical purposes may even lead to lower suicide rates. Currently, 22 states and the District of Columbia have legalized marijuana for medical use, with New York state poised to be the 23rd. About ten other states have also legalized CBD-oil, a non-psychoactive ingredient in marijuana frequently used to treat epilepsy, for research or limited medical purposes. According to a recent CBS News poll, a vast majority of Americans -- over 80 percent -- approve of medical marijuana legalization. While the FDA isn't ready to get on board with legalization, it does seem more interested in the medical benefits of the drug. "The FDA has not approved marijuana as a safe and effective drug for any indication," the FDA stated in its latest guidelines regarding marijuana, posted Friday. "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." http://www.huffingtonpost.com/2014/06/24/fda-marijuana_n_5526634.html
  4. FDA Moves Forward With Marijuana-Based Drug To Fight Childhood Epilepsy The Food and Drug Administration has granted orphan drug designation for a cannabis-based drug developed to treat childhood-onset epilepsy, GW Pharmaceuticals announced last week. Although not full FDA approval -- its maker still must demonstrate the efficacy of the drug in clinical trials -- the orphan drug designation represents a tremendous step forward for cannabis-based medicine. The drug, called Epidiolex, contains a highly purified, plant-derived form of cannabidiol (CBD), a non-psychoactive compound found in marijuana that doesn't produce the "high" sensation associated with THC, the plant's main psychoactive ingredient. CBD has long been used as a treatment for Dravet syndrome, a rare and severe form of epilepsy in children, and GW Pharmaceuticals sees Epidiolex as useful in treating both Dravet and Lennox-Gastaut syndrome (LGS), another rare form of childhood epilepsy. The FDA grants the orphan drug designation to drugs intended to treat rare disorders. It qualifies the maker of the drug for certain tax incentives related to clinical testing as well as an exclusive marketing period for the drug. Currently, the federal government classifies marijuana as a Schedule I substance, but its compounds, like CBD and THC, can be reclassified at a lower level of risk if approved for medical use by the FDA. The agency's approval of the synthetic THC-based drug Marinol in 1985, for example, resulted in THC becoming a Schedule III substance. The classification of marijuana as Schedule I puts the plant into "the most dangerous" category of illegal substances "with no currently accepted medical use." The Schedule I status is why the Obama administration continues to raid medical marijuana dispensaries and prosecute their owners and workers. It's also part of the problem scientists have in obtaining cannabis, and funding, to conduct legal research on the drug in the U.S. If marijuana were reclassified as Schedule III -- like THC -- it would be officially recognized as having an accepted medical use and presenting less potential for abuse. Universities and labs that receive federal funding would find it much easier to conduct research on its potential benefits. According to the National Institutes of Health, Dravet syndrome typically appears in children within their first year of life. Along with frequent seizures, those affected often exhibit poor language development, hyperactivity and difficulty relating to others. Seizures for children affected by Lennox-Gastaut syndrome usually begin before the age of four. The majority of children with the syndrome also experience some degree of impaired intellectual functioning or information processing as well as behavioral disturbances, according to NIH. Currently, there is no cure for either disorder, and FDA-approved medications to treat epilepsy can cause children to become nauseated and develop rashes or, in some cases, depression or hyperactivity. Those drugs may not even effectively treat the seizures the children suffer from. "We are now in active discussions with the FDA regarding the US regulatory pathway for Epidiolex and believe that this medicine has the potential to meet the significant unmet need of children suffering with severe seizures where all options to control those seizures have been exhausted," GW Pharmaceuticals CEO Justin Gover said in a statement after the orphan drug announcement. "GW is responding to this need with the goal of providing an FDA-approved prescription CBD medicine that physicians have confidence in prescribing and parents can trust for quality, consistency and access." Marijuana has a long history of effectively treating seizures. In 1843, British Army doctor William O'Shaughnessy documented his use of cannabis oil to stop an infant's near-constant convulsions. Today, in the 20 U.S. states with legal medical marijuana, many families have been experimenting with a high-CBD, low-THC strain of cannabis to help treat their children who have debilitating seizures. The popular "Charlotte's Web" strain, named after 7-year-old Charlotte Figi and developed by non-profit medical marijuana group Realm of Caring, is being used to treat more than 300 patients suffering from epilepsy in Colorado. Charlotte, who used to suffer from hundreds of seizures a week, was the first child in Colorado to be legally treated with cannabis since medical marijuana was legalized. Her recovery has been miraculous, her mother, Paige Figi, told The Huffington Post. "She is getting a re-do of all the years she was robbed by epilepsy," Figi said. Charlotte's Web and similar medical strains are administered in liquid or capsule form and, according to doctors, produce little to no side effects. Because of the low THC count, users don't experience the high associated with traditional marijuana. In recent years, a number of studies have shown the medical promise of marijuana. Purified forms of cannabis can be effective at attacking some forms of aggressive cancer and may help slow the spread of HIV. Legalization of the plant for medical purposes may even lead to lower suicide rates. Although marijuana appears to be helping many people, some doctors remain cautious. “I worry that we just don’t know enough about it,” Dr. Sharon Levy, of the Boston Children’s Hospital at Harvard Medical School, told NBC News. “I think they’re putting their child at risk of long-term consequences of marijuana use that we don’t fully understand.” Down the road, FDA approval of Epidiolex may produce a cannabis-based drug that skeptical doctors would be comfortable prescribing to their patients. This isn't GW Pharmaceuticals' first foray into marijuana-derived drugs. The company has been developing and testing multiple cannabinoid drugs, including the world's first cannabis plant-derived prescription drug, Sativex, which is used for the treatment of spasticity due to multiple sclerosis in 25 countries. Sativex is not approved by the FDA but is in clinical trials in the U.S. http://www.huffingtonpost.com/2014/0...n_4906832.html
  5. Veterans suffering from Post Traumatic Stress Disorder, commonly referred to as PTSD, rely on medical marijuana to treat a variety of symptoms including haunting nightmares and sleeplessness. The good news: Research to explore marijuana as treatment for PTSD was recently approved. The bad: Study cannot begin until the US Public Health Service gives scientists permission to buy pot. Several months ago, a Food and Drug Administration and University of Arizona Institutional Review Board gave researchers approval to begin studying the effects of marijuana on US military veterans with PTSD. However, the study, which is being financed by the Multidisciplinary Association for Psychedelic Studies (MAPS), has been in limbo for the past 14 weeks because the Public Health Service has not authorized them to purchase “study” marijuana. MAPS Executive Director Rick Doblin, Ph.D. says his team intends to investigate the safety and effectiveness of both smoked and vaporized marijuana on a group of 50 US veterans suffering from “chronic, treatment-resistant” PTSD. Interestingly, previous animal studies have suggested that marijuana effectually offers silence to an overactive fear system, but federal prohibition laws have kept scientists from conducting clinical trails on patients suffering from PTSD. “This groundbreaking research could assist doctors in how to recommend treatment for PTSD patients who have been unresponsive to traditional therapies,” said Dr. Doblin. Before the study can receive the official green light, the Public Health Service must first conduct a special review for the requested marijuana. Although there is a hefty supply of government marijuana allotted for FDA-regulated research, disbursement of this “science weed” is big brothered by the National Institute on Drug Abuse and the Drug Enforcement Administration, who have specifically mandated additional reviews be administered for study marijuana -- no extra review is required for any other substance with a Schedule I classification. After having their research rejected in 2011, MAPS resubmitted revisions to the project in October of last year, but they are not holding their breath for timely response. While the FDA is required to respond to inquiries within 30 days, the Public Health Service has no time constraints. Therefore, until the agency decides they are ready to respond, potentially life saving research is on hold. “If the PHS review requirement was removed,” said Dr. Sue Sisley, who would lead the study, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.”
  6. Universty of Washington to Train on Marijuana Pain Management The University of Washington has been awarded a $110,000 grant from the Washington attorney general’s office to research how marijuana can be used to treat pain and then train health care providers how to effectively treat pain with medical marijuana. In applying to do the work, UW stated that,“Misconceptions about medical cannabis and the lack of science-based education for professionals hinder the benefits that the medical cannabis law can bring to those struggling with chronic pain.” They added in their application that Washington has one of the highest rates of opiate-related mortality in the country. The money was granted by the attorney general’s office to U’s Alcohol and Drug Abuse Institute. The money came about after big pharma company Pfizer agreed to pay more than $42 million in a suit brought by several states, including Washington. The suit was brought about because the company was found to “unlawfully promoting its drugs Zyvox and Lyrica.” Former Washington Attorney General Rob McKenna said “the drug maker engaged in illegal marketing for Lyrica by encouraging its use for the treatment of pain conditions for which the drug is not approved by the FDA.” Washington was granted $1.3 million in the settlement. The only stipulation of the award was that it had to be used to “address direct treatment or research related to chronic pain.” “The grant committee reviewed a variety of projects for breadth of impact as well as geographic, ethnic and project diversity. This UW research project will provide scientific-based information about the medicinal use of marijuana — including chronic pain management,” Janelle Guthrie, spokeswoman for the AG’s office, wrote Seattle PI in an email. [Source]
  7. Though there are currently 18 medical marijuana states, and marijuana possession has been decriminalized in Colorado and Washington, many hurdles still exist when it comes to researching the drug's medicinal benefits. In 1970, under the Nixon administration, Marijuana was classified as a schedule 1 controlled substance, right along with heroine and above cocaine. The schedule 1 label, as determined by the DEA, means that marijuana: (A) has high potential for abuse. (B) The drug or other substance has no currently accepted medical use in treatment in the United States. © There is a lack of accepted safety for use of the drug or other substance under medical supervision. Though the country has moved beyond Nixon, the policies that his administration implemented as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970 were a continuation of drug prohibition policies in the U.S., which started in 1914 with the prohibition of alcohol. Though Doctors and medical officials continue to call for a reclassification of the drug so they may study its therapeutic benefits, the federal supplier of medical grade cannabis, the National Institute on Drug Abuse (NIDA) isn't so keen to move its supply in this direction. For more information on the obstacles that Doctors who wish to study marijuana's medicinal benefits face, click the links below. http://www.popsci.com/science/article/2013-04/why-its-so-hard-scientists-study-pot http://www.sacbee.com/2012/07/12/4625608/california-pot-research-backs.html
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