FDA Allows Narcan to Be Sold Over the Counter
On Wednesday, the Food and Drug Administration (FDA) approved Narcan, an opioid overdose-reversal drug, to be sold over the counter without a prescription. The announcement comes as opioid overdose deaths hover near record highs. At a press conference, the Director of the White House Office of National Drug Control Rahul Gupta said businesses, such as restaurants, banks, and schools will be encouraged to purchase the drug. Narcan manufacturer Emergent BioSolutions said the spray will be available for online and over the counter purchase by the summer.
JAMA: Telehealth Linked to Fewer Opioid Overdoses
A study published in the Journal of the American Medical Association (JAMA), found that the utilization of telehealth services for opioid use disorder during the COVID-19 pandemic reduced the odds for a fatal overdose among Medicare beneficiaries. The study determined that beneficiaries who started treatment during the pandemic and received telehealth services had a 33% lower risk of a fatal overdose. The study also found that fatal drug overdoses were 59% less likely among individuals who received medication to treat opioid use disorder and 38% less likely among those treated with buprenorphine in an office-based setting.
FDA Proposes Overhaul of Fast-Track Approval Process for Cancer Drugs
The FDA’s accelerated approval pathway could become more stringent, according to a draft guidance document released Tuesday. The accelerated approval pathway allows the FDA to approve a drug based on surrogate endpoints rather than a direct measure of a clinical benefit, which allows for drugs to receive an earlier approval. The draft guidance aims to strike a balance between speed and quality by requiring oncology drugs to go through randomized controlled trials (RTCs) that compare the effectiveness of an experimental drug against a conventional one. The deadline for stakeholders to comment on the draft guidance is May 26, 2023.
Lawmakers Question Becerra on Coverage Determination for Alzheimer’s Drug
In multiple hearings to review the president’s proposed Fiscal Year (FY) 2024 budget, several Republican lawmakers voiced their criticism of a decision by the Centers for Medicare and Medicaid Services (CMS) to limit coverage of a class of Alzheimer’s drugs only to patients who are participating in relevant clinical trials. These drugs, which utilize amyloid plaque-blocking technology, have been marred with controversy due to their high cost and risk of side effects such as brain swelling and brain bleeding. In response to the criticism, Health and Human Services Secretary Xavier Becerra repeatedly explained that FDA and CMS have different criteria for evaluating experimental drugs as mandated by law.
Most Doctors Say COVID-19 Misinformation a Problem
Seven in 10 doctors say misinformation about COVID-19 has made it harder to treat patients, according to a poll by the de Beaumont Foundation and Morning Consult. A similar number of physicians surveyed said misinformation has negatively impacted patient outcomes. The survey also found that 90% of physicians surveyed agreed on the benefits of COVID-19 vaccines. Most doctors also noted that COVID-19 misinformation has seeped into other areas of health care, with two-thirds saying misinformation is common regarding weight loss, dietary supplements, mental health, and other vaccines.
Former Congressional Aide Launches Union Tracker for Senate Staff
A former member of Minnesota Sen. Tina Smith’s staff launched a Senate Union Tracker earlier this month as a way to track which senators support collective bargaining protections for Senate staff and efforts to unionize among their own staff. Motivated by subpar pay and long hours during his time in the Senate, the former staffer hopes the tracker will help improve working conditions for those still working in the Senate. Since the website launch, over a dozen Democrats have favorably voiced their support for unionization in the tracker.