FDA to Host Meeting on Patient-Focused Drug Development for Opioid Use Disorder

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The Food and Drug Administration (FDA) will host a public meeting April 17 on patient-focused drug development for opioid use disorder (OUD), in collaboration with the National Institute on Drug Abuse. The FDA is also working closely with patient advocacy and community organizations to encourage participation from people with OUD. The FDA is interested in learning patients’ perspectives on OUD, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for the disorder. The meeting will take place at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Room 1503A (Great Room), Silver Spring, Maryland, from 10 a.m. to 4 p.m.
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FDA to Allow Drug Companies to Sell Wider Range of Opioid Addiction Treatments

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The Food and Drug Administration (FDA) will allow drug companies to sell medications that reduce opioid cravings, even if they do not fully stop addiction, The New York Times reports. In a speech at the National Governors Association, Health and Human Services Secretary Alex Azar noted only one-third of specialty addiction treatment programs offer medication-assisted treatment (MAT). “We want to raise that number — in fact, it will be nigh impossible to turn the tide on this epidemic without doing so,” he said. Azar added the FDA intends “to correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.” The FDA will encourage development of medications that can help patients function better and can be helpful when used in combination with therapy and other social support, even if the medications don’t completely end addiction, an agency official told the newspaper.
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FDA Announces Voluntary Destruction and Recall of Kratom Products

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The Food and Drug Administration (FDA) this week announced it is overseeing the voluntary destruction and recall of kratom products. Earlier this month, the FDA warned kratom is an opioid and has been linked with 44 deaths. Kratom, an unregulated botanical substance, is used by some people to relieve pain, anxiety and depression, as well as symptoms of opioid withdrawal. The company that makes kratom-containing products under the brand names Botany Bay, Enhance Your Life and Divinity promised to recall and destroy the products, HealthDay reports. The company, Divinity Products Distribution, agreed to stop selling all products containing kratom. In a statement, the FDA said, “Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take...
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FDA Calls Kratom an Opioid

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The Food and Drug Administration (FDA) is warning that the supplement known as “kratom” is an opioid and has been linked with 44 deaths, The Washington Pos t reports. Kratom, an unregulated botanical substance, is used by some people to relieve pain, anxiety and depression, as well as symptoms of opioid withdrawal. The FDA recently conducted a scientific analysis that provided even stronger evidence of kratom’s opioid properties, the agency said in a statement. “We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” said FDA Commissioner Scott Gottlieb. The analysis has “contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.”
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FDA Asks Makers of Anti-Diarrhea Drug to Change Packaging to Curb Abuse

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The Food and Drug Administration (FDA) this week asked the makers of the over-the-counter anti-diarrhea drug loperamide (Imodium A-D) to change the way they package their products, in an effort to reduce abuse. Some people take extremely high doses of loperamide in an attempt to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use, the FDA said in a statement. Loperamide is safe when used at recommended doses, The Washington Post reports. But when it is taken at extremely high doses, the drug can cause dangerous, irregular heartbeats. The FDA is asking manufacturers to redesign their packages so they contain only enough medication for short-term use. The agency is also asking for “unit dose packaging,” such as blister packs that require a person to unpeel each dose separately.
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FDA Encourages Use of Medication-Assisted Treatment for Opioid Addiction

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The Food and Drug Administration (FDA) will encourage widespread use of medication-assisted treatment for opioid addiction, the agency’s commissioner said recently. The FDA has approved three medication-assisted treatment drugs: buprenorphine, methadone and naltrexone. A report issued last year by Pew Charitable Trusts concluded that medication-assisted treatment is the most effective way to deal with opioid use disorder. FDA Commissioner Scott Gottlieb, appearing before the House Committee on Energy and Commerce, said, “Unfortunately, far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications. In part, this is because insurance coverage for treatment with medications is often inadequate.” In his remarks, Gottlieb noted that some people may need medication-assisted treatment for years, if not for their entire lives. He said the FDA will issue guidance to drug manufacturers to promote the development of new addiction treatments, The Washington Post reports.
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FDA Requires Makers of Fast-Acting Opioids to Pay for Doctor Training

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The Food and Drug Administration (FDA) announced it will require makers of fast-acting opioids to fund voluntary training for healthcare professionals who prescribe the drugs, according to Reuters . The training will include education on safe prescribing practices and non-opioid alternatives. The FDA informed 74 manufacturers of immediate-release opioids that they will have to fund training for doctors, nurses and pharmacists. Companies that make extended-release and long-acting formulations of opioids already must pay for training of healthcare professionals. The FDA is also considering some type of mandatory education on opioids, the article notes. According to the FDA, approximately 160 million prescriptions a year – about 90 percent of all opioid pain medications prescribed in the United States – are for fast-acting formulations.
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FDA Requests Removal of Opana ER For Risks Related To Abuse

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The U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a...
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Weakening FDA’s Authority Over Tobacco Could Impact Use, Advocates Say

Weakening FDA’s Authority Over Tobacco Could Impact Use, Advocates Say
Weakening the Food and Drug Administration’s (FDA) regulatory authority over tobacco could have an adverse impact on tobacco use, according to advocacy groups. Congress is considering a bill that would allow flavored e-cigarettes and other non-traditional cigarette tobacco products to stay on the market, despite the enactment of a rule last year that gives FDA regulatory authority over all tobacco products, including e-cigarettes and cigars. “This is especially troubling because the Surgeon General has found that these flavors are particularly attractive to kids,” said Erika Sward of the American Lung Association. She noted that flavorings are believed to be a major cause of the more than 10-fold increase in e-cigarette use among high school-age students between 2011 and 2015. There is “real concern about what lies ahead for reducing tobacco use and, specifically, whether the FDA’s existing authority will be weakened,” she told MedPage Today .
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FDA Issues Warning Letters to Websites, Stores Selling E-Cigarettes to Minors

FDA Issues Warning Letters to Websites, Stores Selling E-Cigarettes to Minors
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