FDA Announces New Opioid Strategy: ‘We’re Not Winning The Battle At This Point’
The Food and Drug Administration will now mandate that any new opioid go before an outside committee of experts, unless the product has abuse-deterrent properties, and require more warnings and safety information on drug labels, said Robert Califf, the White House's nominee to direct the FDA. But even with that announcement, three of the senators who have placed holds on Califf's nomination do not plan on removing them, saying the steps "fall short of what is needed."
The Washington Post:
‘We Can Do More,’ FDA Says In Announcing Overhaul Of Approach To Opioid Painkillers
The Food and Drug Administration, which has been criticized as too willing to approve addictive narcotic painkillers and too slow to fight their abuse and overuse, said Thursday that it will overhaul policies addressing the powerful class of drugs. The announcement comes amid an epidemic of prescription drug and heroin overdoses, which now kill more Americans each year than automobile accidents. (Dennis, 2/4)
The Wall Street Journal:
FDA Gets Tougher On New Painkillers In Light Of Overdoses
The Food and Drug Administration, hoping to reduce deaths related to the abuse of powerful painkillers, said it would insist that new versions of the drugs get tougher scrutiny and that manufacturers gather evidence about their effects once they are on the market. The changes were announced by Robert Califf, the FDA’s deputy commissioner and the White House’s nominee to become commissioner. (Burton, 2/4)
CQ Healthbeat:
FDA Outlines Changes To Opioid Approvals
A week after three senators said they would block the nomination of Robert Califf to lead the Food and Drug Administration over agency policies on opioid painkiller approvals, the FDA announced plans on Thursday to help address the opioid abuse epidemic. The announcement, however, may not change the outlook for Califf. Sen. Edward J. Markey, D-Mass., who along with Sen. Joe Manchin III, D-W.V. and Sen. Kelly Ayotte, R-N.H., has blocked the nomination over this issue, will not lift his hold in light of the announcement, his office said on Thursday. (Siddons, 2/4)
The Hill:
Dems 'Not Impressed' With The FDA's Plan To Fight Drug Abuse
A Democratic senator said he will not remove his hold on President Obama's nominee to lead the Food and Drug Administration nominee even after the agency announced a sweeping plan to tackle drug abuse in an effort to sway the senator. Sen. Ed Markey (D-Mass.) said he would continue his hold on Dr. Robert Califf until the FDA agrees to an even wider review of its process of approving prescription painkillers, which are fueling an opioid epidemic in his state and many others. (Ferris, 2/4)
Meanwhile states address the opioid crisis —
The Baltimore Sun:
Md. Legislation Would Create Drug-Use Facilities, Decriminalize Possession Of Small Amounts
Nearly 47,000 Americans died from a drug overdose in 2014 — more than from gunshot wounds or car crashes. In Maryland, the governor's office has defined the problem as an "epidemic … destroying lives." Indeed, heroin deaths alone have increased by 186 percent from 2010 to 2015 in the state. Not only are drug related deaths on the rise, so are the associated harms, including: drug-related crime and violence, the spread of HIV/AIDS and Hepatitis C and the financial burden for taxpayers who shoulder the costs of health care and criminal justice. (LaSalle, 2/4)
The Connecticut Mirror:
Courtney Seeking Emergency Money To Fight Opioid Addiction, Overdoses
Days after President Obama said he’d ask Congress to boost funds to fight opioid and heroin addiction, Rep. Joe Courtney introduced a bill that would seek $600 million in emergency funds to pay for both drug enforcement and treatment. (Radelat, 2/4)