Opioids

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.

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.

FDA Commissioner Scott Gottlieb tried to assure a National Academies of Sciences, Engineering and Medicine (NASEM) committee that while the agency plans to develop and publish prescribing guidelines for acute pain, the agency does not intend to regulate the practice of medicine.

A leading public health advocate official is hopeful the incoming Democratic-led House will investigate FDA’s controversial approval of the sufentanil drug DSUVIA.

With Democrats taking control of the House, Rep. Frank Pallone (D-NJ) is highly expected to chair the powerful Energy & Commerce Committee, and, although he comes from a pharmaceutical-heavy district, he told Inside Health Policy prior to the election results that tackling high drug prices would be a top priority as would overseeing the administration's health care agenda.