Opioids

A prominent consumer advocacy group and an FDA advisory committee chair filed a citizen petition on Thursday (March 21) demanding FDA slap an immediate moratorium on the approval of new opioids until it revamps its regulation and review of new opioids as recommended by the National Academies of Sciences, Engineering, and Medicine in 2017.

The director of the White House Office of National Drug Control Policy (ONDCP) agreed to provide more information to the chair of the House Oversight & Reform Committee on the office’s drug policy strategy after a Government Accountability Office report released Thursday (March 7) found that the strategy lacked required information, such as measurements of performance goals.

Provider groups and insurance plans applauded a CMS proposal to increase access to the opioid overdose reversal drug naloxone included in the agency’s 2020 draft Medicare Advantage and Part D call letter, but some groups called for CMS to reconsider a proposal on co-prescribing the drug with opioid prescriptions, saying that decision should be left between a provider and patient.

House Energy & Commerce ranking Republican Greg Walden (OR) will speak with FDA Commissioner Scott Gottlieb about marijuana-related issues as part of a regular meeting the congressman has with the agency head, Walden told Inside Health Policy after speaking at an event at the American Enterprise Institute.

West Virginia’s senators are asking lawmakers to support them in pushing HHS to align the strict privacy scheme for substance abuse treatment records with the looser Health Insurance Portability and Accountability Act (HIPAA), echoing the calls of physician and hospital groups.

A coalition of organizations focused on health care, public health and safety, drug diversion prevention, and drug abuse prevention and treatment, and a former congresswoman, wrote to FDA Commissioner Scott Gottlieb urging the agency to embrace innovative, at-home systems for disposal of drugs when it implements wide-ranging legislation passed last year as part of congressional efforts to curb the opioid crisis.

FDA on Wednesday (Feb. 6) finalized guidance detailing the types of clinical studies and novel endpoints that can be used to support approval of depot buprenorphine products and how sponsors should design efficacy trials.

In an effort to encourage drug companies to develop over-the-counter (OTC) versions of overdose-reversal drug naloxone, FDA has developed a model drug facts label with pictograms that show how to use the drug, which can help consumers better understand how to use naloxone without the supervision of a health care professional, agency chief Scott Gottlieb announced on Thursday (Jan. 17).

The Institute for Clinical Economic Review (ICER) on Monday (Dec. 3) issued a final report featuring recommendations for how to develop policy on and increase access to extended-release medications for addiction treatment.