abusethe divisions over the new drugs approval comes after opioid overdose deaths surged to more than 40000 last year including more than 30000 from fentanyl and other synthetic opioids states and the federal governments have cracked down on the prescribing of opioids and many chronic pain patients have complained about being undertreated or losing access to opioids entirelydr brown who heads the advisory committee on analgesics and anesthetic drug products was not present for the committee vote last month but in the letter he wrote afterward he described trying to resuscitate doctors medical students and other health care providers some successfully who had overdosed on the iv form of sufentanil at the medical center where he worksit is so potent that abusers of this intravenous formulation often die when they inject the first dose he wrotedr brown also questioned whether the fda would succeed in enforcing regulations once dangerous drugs hit the marketit is my observation that once the fda approves an opioid compound he wrote there are no safeguards as to the population that will be exposed the postmarketing analysis of prescribing behavior or the ongoing analysis of the risks of the drug to the general populationcritics of the approval include four democratic senators edward markey of massachusetts richard blumenthal of connecticut claire mccaskill of missouri and joe manchin of west virginiain a letter to dr gottlieb on tuesday they questioned why dr browns committee went ahead and recommended approval on oct 12 without him present they also asked why a different fda advisory group the drug safety and risk management advisory committee had not been involvedan fda spokeswoman said that while the issue was not brought formally in front of the drug safety committee there were drug safety and risk experts on the committee whose expert input was taken very seriously throughout this process