Opioids

The White House Office of National Drug Control Policy (ONDCP) said Friday (May 3) that its national drug policy strategy will reduce drug overdose deaths by 15% in five years, two months after a Government Accountability Office (GAO) report said the strategy lacked key information.

FDA is convening two of its advisory committees to discuss safety concerns and clinical usefulness of higher-strength and higher daily doses of opioids during a meeting slated for June 11, the agency announced Friday (April 26).

FDA on Friday (April 19) approved the first generic naloxone nasal spray, commonly known as Narcan, for use in a community setting by people who do not have medical training.

FDA and Customs and Border Protection (CBP) signed an agreement Thursday (April 4) to expand how information is shared between the two agencies and coordinate shared space to target entry of illicit drugs coming into the country through international mail facilities (IMFs).

CMS on Monday (April 1) finalized its call for Medicare Advantage and Part D plans to do more to reduce opioid dependence among beneficiaries and expand access to naloxone, the opioid overdose reversal drug, by reducing beneficiaries’ costs through new tiering policies, among other possible actions.

New York state has filed a lawsuit against opioid makers and distributors and the Sackler family, which founded Purdue Pharma and developed OxyContin, for false and deceptive marketing of opioids that the state alleges helped spur the opioid epidemic, New York Attorney General Letitia James announced Thursday (March 28).

A prominent consumer advocacy group and an FDA advisory committee chair are calling for FDA drug center chef Janet Woodcock to step down from her post in order to clear a path for the agency to revamp its regulation of opioids and implement recommendations made in 2017 by the National Academies of Sciences, Engineering, and Medicine.

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

Specialists in the fields of addiction and mental health urged Congress on Wednesday (March 6) to give more federal money to providers on the front lines of the opioid crisis -- including by funding several programs that were authorized in last year’s major opioid bill.