FDA Stakeholder Update - October 25, 2018

Dear Colleague,

Over the past week, FDA has had some notable News and Events and statements from FDA Commissioner Scott Gottlieb, M.D. and we want to ensure that you are aware of them. If you have any questions please feel free to contact our office FDAstakeholderengagement@fda.hhs.gov .

October 24, 2018

• Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. we took an important step forward in combatting the devastating crisis of opioid addiction plaguing our nation. The President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, bipartisan legislation that builds on the notable progress we’ve made addressing the human and financial toll of the opioid crisis. Read Full Statement
• FDA approves a new a drug to treat influenza: Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Read Full News Release

October 23, 2018

• FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids: FDA in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers. Read Full News Release
• Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths: With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it’s critical that we continue to tackle this human tragedy from all fronts – including, and importantly, looking at new ways to increase the availability of naloxone. Read Full Statement

October 22, 2018
 

• Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death: When we first unveiled our comprehensive plan on tobacco and nicotine regulation, we set out to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally or nonaddictive; and harnessing new forms of nicotine delivery that could allow currently addicted adult smokers to get access to nicotine without all the risks associated with lighting tobacco on fire. Read Full Statement