The Drug Enforcement Administration (DEA) on Friday announced that it is moving to require in-person visits for certain controlled medications, in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and Ohio.
- District of Columbia: DEA on Friday announced that it is moving to require in-person visits for certain controlled medications, including Adderall and OxyContin. The agency said it is aiming to reverse rule changes made under the COVID-19 public health emergency that allowed doctors to prescribe strong drugs with a telehealth appointment. Under the proposed changes, it will be more difficult for Americans to access potentially addictive medications designed to treat pain and mental health disorders. While the Biden administration is planning to expand telehealth flexibilities for non-controlled medications, it will ban doctors from prescribing schedule II medications and narcotics unless the patient is evaluated at an in-person appointment. Doctors will only be allowed to prescribe other controlled medications or medications used to treat opioid addiction for 30 days, and any refills will require an in-person evaluation. (Habeshian, Axios, 2/24)
- Maryland: On Tuesday and Wednesday, FDA's Vaccines and Related Biological Products Advisory Committee is determining whether the risk-benefit profiles of two vaccine candidates – one from Pfizer and the other from GlaxoSmithKline – support approval for the reduction of respiratory syncytial virus (RSV)-related lower respiratory tract infections in adults aged 60 and older. Before the meeting, FDA reviewers highlighted a rare risk for Guillain-Barré syndrome (GBS) with the two vaccine candidates. In phase III trials, both vaccine candidates were over 66% effective against RSV-related infections involving multiple symptoms. "Given the higher than background rate of GBS [Guillain-Barré syndrome] observed in the Phase 3 study, FDA will recommend a postmarketing study and enhanced surveillance for further evaluation of GBS and other immune-mediated demyelinating conditions with postmarketing use," FDA staff wrote. (Hein, MedPage Today, 2/27)
- Ohio: Last week, CDC epidemiologists and environmental health scientists arrived in Ohio to help evaluate health risks after a train carrying chemicals and combustible materials derailed in East Palestine last month, releasing toxic gases into the environment of the surrounding areas. According to Politico, CDC's Agency for Toxic Substances and Disease Registry came to assist the Environmental Protection Agency and the state's health department execute the emergency response, gauge contamination levels, and communicate risks to the public. CDC expects to send another team to the area to conduct a "rapid epidemiological assessment" to evaluate the impact on residents' health. (Mahr/Payne, Politico, 2/21)