Public Policy Updates

3/29/22 — The FDA issued warning letters jointly with the Federal Trade Commission to seven companies for selling CBD products using research studies to claim or imply misleadingly that their CBD products will cure, mitigate, treat or prevent COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The companies that received warning … Continued

3/29/22 — The FDA authorized and CDC recommended an additional COVID-19 booster for adults age 50 + and people age 12+ who are immunocompromised at least four months after receiving their first booster. Read the FDA authorization and the CDC recommendation.

3/29/22 — At the request of Pacific PPE Corporation, NIOSH has rescinded all respirator approvals issued to that company. Respirators bearing the following approval numbers may no longer be manufactured, assembled, sold, or distributed: • TC-84A-9278 • TC-84A-9299 • TC-84A-9313 Read the NIOSH notice of the voluntary rescission.

3/25/22 — The FDA has rescinded EUA for sotrovimab to treat COVID-19 in HHS Regions 1 and 2 because the authorized dose is unlikely to be effective against the Omicron BA.2 sub-variant. CDC Nowcast data estimates that, as of March 19, 2022, the BA.2 sub-variant accounts for more than 50 percent of COVID-19 cases in these regions. HHS Regions … Continued

3/25/22 — Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level.  The products are being recalled due to microbial … Continued

3/28/22 — The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel updated the following treatment recommendations: Testing for SARS-CoV-2 Infection Pre-exposure prophylaxis (PrEP) Prioritization of anti-SARS-CoV-2 therapies for treatment and prevention of COVID-19 when there are logistical or supply constraints Granulocyte-macrophage colony-stimulating factor inhibitors (GM-CSF)

3/23/22 — The Agency for Healthcare Research and Quality (AHRQ) developed a toolkit to help hospital infection prevention programs implement a decolonization protocol that was found to reduce bloodstream infections by more than 30 percent in adult inpatients who were not in intensive care units (ICUs) and who had specific medical devices. It includes implementation instructions, … Continued

3/21/22 — The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on April 6 to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Read the FDA announcement.

3/21/22 — In recognition of interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes, the FDA sent a letter to healthcare personnel that included recommendations, including conservation strategies, to maintain the quality and safety of patient care. Read the FDA letter.