Texas Medical Board Doesn’t Specify Abortion Ban Exceptions in Proposed Rules
The Texas Medical Board has issued proposed rules for when emergency abortions can legally be performed under the state’s 6-week abortion ban — but it won’t specifically enumerate those exceptions. The proposed rules come in response to a law that took effect in September 2021, which banned abortions after 6 weeks’ gestation except to save […]
New Monoclonal Authorized to Prevent COVID in Immunocompromised People
The FDA issued an emergency use authorization (EUA) for pemivibart (Pemgarda) as COVID-19 pre-exposure prophylaxis in immunocompromised individuals who are unlikely to mount a sufficient immune response following vaccination, the agency announced on Friday. A long-acting monoclonal antibody, pemivibart is specifically authorized for people ages 12 years and older (and weighing 40 kg or more) […]
EPA Imposes New Limit on Medical Sterilization Chemical, Citing Cancer Risk
The Environmental Protection Agency (EPA) issued a final rule on Thursday that aims to markedly reduce cancer risks for those living near commercial sterilization facilities by lowering toxic emission standards for ethylene oxide. Ethylene oxide, the most commonly used sterilant for medical devices in the U.S., is used for everything from wound dressings to endoscopes […]
Q&A: Talking Prior Authorization With Rep. Suzan DelBene
Although the Centers for Medicare & Medicaid Services (CMS) issued a final rule on prior authorization, there is more that can be done to ease clinician burdens in this area, according to Rep. Suzan DelBene (D-Wash.). DelBene sponsored the Improving Seniors’ Timely Access to Care Act, which would, among other provisions, require affected plans to […]
Trump-Era Conscience Rule Rescinded; Lloyd Austin’s Cancer; Sinead O’Connor’s Death
Note that some links may require registration or subscription. HHS issued a final nondiscrimination rule that partly rescinds a sweeping 2019 Trump-era “conscience” rule, clarifying the process for enforcing federal conscience laws in healthcare and strengthening protections against conscience and religious discrimination. HHS Secretary Xavier Becerra appeared to be making inroads with President Biden’s closest […]
Lab Tests That Escape FDA Oversight May Come Under Agency Review
The FDA issued its long-awaited proposal for regulating laboratory developed tests (LDTs) on Friday. The proposed rule would amend FDA regulations to make explicit that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. The agency also wants […]
CDC Issues Sepsis Care Guidance for Hospitals
The CDC issued new guidance to hospitals Thursday for managing sepsis and called on hospitals to do better at treating it. “Every hospital, regardless of size, location, and resources can strengthen the quality of care delivered to these patients and ensure their survival,” CDC Director Mandy Cohen, MD, MPH, said at a press conference. “That’s […]
Experts Quell Worries About Locally Acquired Malaria in the U.S.
Earlier this week, the CDC issued an alert on the first locally acquired malaria cases in the U.S. in 20 years. MedPage Today spoke with experts and physicians to determine how rare the cases are, whether there may be more, and what may have contributed to them. Within the last 2 months, four locally acquired […]
Another Online SARMs Retailer Gets a Warning From the FDA
The FDA issued a warning letter to an online retailer selling multiple selective androgen receptor modulators (SARMs) earlier this month, in an ongoing effort to curb their use in consumers, the agency said. This recent letter advised a California-based company, known as Warrior Labz SARMS, and its owner, Jeremy Brown, to stop actively marketing SARMs […]
Tainted ‘Male Enhancement’ Pills; Green Card Freeze Hits Nursing; Monkeypox Rebounds
Note that some links may require subscriptions. The FDA issued multiple new warnings over tainted sexual enhancement products that contain “potentially harmful hidden ingredients,” some of which are found in prescription drugs. Private equity-backed Envision Healthcare filed for bankruptcy, but a group of emergency room doctors plans to keep suing the controversial staffing firm anyway. […]