The Food and Drug Administration this week issued guidelines for drug manufacturers on developing opioid painkillers that are more difficult to abuse. The guidelines recommend the types of studies needed to prove drugs can deter abuse, The Wall Street Journal reports.
Although alcohol in powdered form has been around for decades – long before a 1976 patent for it was issued to the General Foods Corporation – the announcement of a new product tabbed for the market has pushed the topic back to the forefront.
Drugs to treat alcoholism would not have to lead to sobriety in order to be approved by the Food and Drug Administration, under a proposal by the agency. Instead, drug companies could gain approval for treatments if they prove patients using them no longer drink heavily.
A group of activists says the Food and Drug Administration has worsened the opioid overdose epidemic. They are calling on the head of the agency, Commissioner Margaret A. Hamburg, to quit, The Washington Post reports.
A group of 29 state attorneys general urged the Food and Drug Administration to impose restrictions on e-cigarettes, according to The Wall Street Journal. They are asking for a ban on television ads and on candy and fruit flavors.
New federal tobacco regulations contain a cost-benefit calculation known as the “happiness quotient,” which weighs the health benefits of reduced smoking against the loss in pleasure that smokers suffer when they quit. This calculation could make it harder for the Food and Drug Administration to take strong action against tobacco companies, critics say.
A new painkiller that combines oxycodone and naloxone was approved by the U.S. Food and Drug Administration on Wednesday. Naloxone was included in the drug to block the euphoric effects of oxycodone, making it less appealing to abuse.
A federal judge ruled this week that the Food and Drug Administration cannot use findings from a panel report that recommended removing menthol cigarettes from the market. Three of the panel members had conflicts of interest, the judge said.
The consumer advocacy group Center for Science in the Public Interest is urging the Food and Drug Administration to put safety warnings on energy drinks, according to Reuters. The drinks have been linked to 17 deaths in the past two years.
The Food and Drug Administration (FDA) will develop e-cigarette policies that will protect public health, the head of the agency’s Center for Tobacco Products said Wednesday. The FDA is considering product standards in the areas of addiction, toxicity and product appeal.
The Food and Drug Administration’s decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone, has stirred opposition from many addiction medicine experts, public health officials and legislators. Join Together spoke with Dr. Richard Blondell, Vice Chair for Addiction Medicine in the State University of New York at Buffalo Department of Family Medicine, about the issue.
Manufacturers of e-cigarettes say they are pleased with the Food and Drug Administration’s proposed regulations of e-cigarettes, The Wall Street Journal reports. Consumer groups said the rules don’t go far enough, according to USA Today.
The Food and Drug Administration announced new rules on Thursday that would allow the agency to regulate e-cigarettes, The New York Times reports. The proposed rules would ban the sale of e-cigarettes, cigars and pipe tobacco to anyone under age 18.
An advisory panel of the Food and Drug Administration voted Tuesday against approving a combination morphine-oxycodone painkiller, NPR reports. The drug, Moxduo, would be the first medication to combine both opioids in one capsule.