Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Takes Steps To Encourage Development Of Medication That Can Be Used To Aid Addiction Treatment
The Food and Drug Administration (FDA) on Monday took a step to encourage the development of more drugs to treat opioid addiction. The FDA issued guidance to encourage the development of more drugs that can be used in what is known as Medication Assisted Treatment, a leading way to treat people with opioid addiction, through using certain drugs to reduce dependence on opioids. (Sullivan, 8/6)
Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases. 鈥淲e must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,鈥 FDA Commissioner Scott Gottlieb said in a statement. (Facher, 8/6)
The recommendations follow earlier draft guidance the agency released in April that outlined the FDA's current position on drug development and trial design issues as related to the study of new buprenorphine products. In that document, the agency suggested some of those products鈥攕uch as extended-release versions and implants鈥攎ay not need new safety and efficacy clinical trials such as those for new drugs seeking regulatory approval. Both documents reflect a noticeable shift in the FDA's position related to the drug approval process. The agency is opting for shorter studies and faster approvals for new medication-assisted treatments as the opioid epidemic continues to impact the nation, causing more than 42,000 deaths in 2016 and a 30% rise in emergency department visits from 2016 to 2017 across 45 states. (Johnson, 8/6)
惭别补苍飞丑颈濒别听鈥
Four inmates sit silently in the library of the Franklin County House of Correction one summer morning. But these men aren't here to read books. Under the supervision of a nurse and two corrections officers, they're taking their daily dose of buprenorphine. The drug, often known by the brand name Suboxone, is meant to control their heroin cravings and is commonly smuggled into jails and prisons. (8/7)