FDA Committee Favors OTC Opill, WHO Ends Mpox Emergency
New over-the-counter birth control pills could be coming, and two public health emergencies come to an end.
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By - In healthcare policy news this week, the FDA seems primed to approve over-the-counter sales of birth control pills. Meanwhile, the World Health Organization (WHO) ended the mpox public health emergency despite warnings from the CDC about vaccine-resistant cases.
Legislators Press VA Executives on Pharmaceutical Errors with EHR
Last week, Department of Veterans Affairs officials were questioned by members of the House of Representatives about recent issues regarding pharmacy features of the Agency’s Oracle Cerner EHR system. Comments from a pharmacist at the Mann-Grandstaff VA Hospital were read in the session that focused on the delays and risks associated with the new EHR. According to that pharmacist, staff members have been on high alert since the new system’s launch after they experienced a lack of responsiveness and several vulnerabilities that had become a threat to patient safety. READ MORE.
HHS Explains Post-COVID Telehealth Flexibilities
The Department of Health and Human Services (HHS) released a factsheet on May 11 explaining the new state of telehealth in the United States after the COVID-19 public health emergency. Telehealth flexibilities enacted by HHS will end next year, requiring in-person evaluations for prescribing controlled substances. READ MORE.
FDA Advisory Committee Favors Over-the-Counter Opill
The FDA advisory committees on nonprescription and urologic drugs convened last week and voted in favor of switching Perrigo’s Opill birth control to an over-the-counter designation, expanding access for women across the United States.
"Today's vote to recommend a switch of Opill to OTC is a new, groundbreaking chapter in reproductive health. Perrigo is proud to lead the way in making contraception more accessible to women in the US," said Perrigo President and Chief Executive Officer Murray S. Kessler in the press release. READ MORE.
WHO Ends Mpox Emergency
The World Health Organization announced the end of the global mpox public health emergency last Thursday despite the CDC’s indication that a resurgence is possible in the US. WHO officials noted a 90 percent reduction in cases over the past three months as a reason to end the public health emergency, but CDC officials are currently investigating new mpox cases occurring in patients who had been vaccinated for the disease. READ MORE.
Department of Agriculture Licenses Lyme Vaccine
The Department of Agriculture conditionally licensed an oral vaccine for Borrelia burgdorferi, the bacteria that causes Lyme disease. LymeShield, the product manufactured by Memphis-based US Biologic, will be delivered via feed pellets to wild mice in natural settings.
“Lyme disease and other tick-borne diseases present a tremendous public healthcare challenge,” says Scott Williams, MD, Chief Scientist and Department Head at CAES, which performed field trials of the vaccine in residential settings in Redding, Connecticut. “We need to continue to support efforts to innovate and provide these types of new tools.” READ MORE.
