Abstral OKed as breakthrough pain treatment for cancer patients
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.
The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.
“This is an important step for patients with cancer pain to have options for the treatment of their breakthrough pain,” FDA Office of New Drugs director John Jenkins said.
The drug will have a Risk Evaluation and Mitigation Strategy, or REMS program, designed to minimize the risk of misuse, abuse, addiction and overdose, the FDA said.
Warning issued to consumers over extortionists posing as FDA agents, federal officials
SILVER SPRING, Md. — International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.
The FDA said the criminals will call the victims, who often previously purchased drugs through “telepharmacies” or over the Internet, and tell them that purchasing drugs online or over the telephone is illegal. They then attempt to extort “fines” ranging from $100 to $250,000 and instruct victims to transfer the money to a designated location, usually in the Dominican Republic, threatening the victims with property searches, arrests, deportations or physical harm if they fail to comply.
“Impersonating an FDA official is a violation of federal law,” FDA associate commissioner for regulatory affairs Dara Corrigan said. “FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action.”
FDA on lookout for tobacco violations in Mississippi
SILVER SPRING, Md. — Nearly 500 retailers in Mississippi had to submit to Food and Drug Administration inspections concerning alleged tobacco sales to minors, the FDA said Friday.
The FDA said it visited 493 retailers and issued 25 warning letters over the last three months using state inspectors the agency had commissioned. Mississippi was the first state to participate in the FDA’s State Enforcement Program, which started in the summer and is designed to enforce provisions of the Family Smoking Prevention and Tobacco Control Act of 2009 and implement regulations.
“Retailers play a role in protecting our kids from becoming the next generation of Americans to die prematurely from tobacco-related disease,” FDA Center for Tobacco Products director Lawrence Deyton said. “We are providing retail establishments with the information needed to comply with the law.”