Pharma & Life Sciences

MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks feedback on extending current transitional arrangements and introducing an international reliance route to ensure continued supply and patient access to medical technologies. The deadline for feedback is April 10, 2026.

MHRA Consultation on CE Marked Medical Device Recognition

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks views on extending transitional arrangements for MDD-compliant devices and indefinitely recognising EU MDR/IVDR compliant devices, with a comment deadline of April 10.

MHRA Seizes 20 Million Illegal ED Pills, Warns Against Online Buys

The MHRA announced the seizure of nearly 20 million illegal erectile dysfunction pills between 2021 and 2025, including 4.4 million in 2025 alone. The agency is warning the public against purchasing unauthorized medicines online due to significant health risks.

Missouri Failed to Collect $12.2M in Medicaid Drug Rebates

The HHS Office of Inspector General (OIG) found that Missouri failed to collect $12.2 million in federal rebates for Medicaid physician-administered and pharmacy drugs between January 1, 2019, and December 31, 2022. The OIG recommends Missouri refund the federal government $9.7 million for physician-administered drugs and $2.5 million for pharmacy drugs.

ACF Contract for Unaccompanied Alien Children Services Noncompliant

The HHS OIG found that the Administration for Children and Families (ACF) awarded a $529 million sole source contract for unaccompanied alien children services in a noncompliant manner. The contract was double the cost estimate and lacked required pre-award documentation.

HHS OIG: West Virginia Failed to Collect $6.1M in Medicaid Drug Rebates

The HHS Office of Inspector General found that West Virginia failed to collect an estimated $6.1 million in federal rebates for physician-administered drugs dispensed to Medicaid managed-care enrollees. The audit identified failures in internal controls that prevented the state from invoicing manufacturers for these rebates.

MHRA Restricts Chikungunya Vaccine IXCHIQ Use

The MHRA has introduced additional restrictions on the use of the Chikungunya vaccine IXCHIQ. The vaccine is now restricted to adults aged 18-59 without specific pre-existing health conditions, following reports of serious adverse reactions, including fatalities. Healthcare professionals must conduct a benefit-risk assessment before administration.

Pharmacy Commission Meeting Minutes and Actions

The Connecticut Commission of Pharmacy met on October 30, 2024, approving a new pharmacy application with modifications, a pharmacy remodel, and issuing fines totaling $3,000 to Walgreens for violations related to pharmacy closures and compounding standards. The commission also approved reciprocity and new applications.

Pharmacy Commission Meeting Agenda - October 30, 2024

The Connecticut Pharmacy Commission meeting agenda for October 30, 2024, outlines discussions on new pharmacy applications, remodels, pharmacy manager appointments, and reciprocity interviews. The agenda also includes requests for new non-resident pharmacy applications and updates on previously approved or denied applications.

Pharmacy Commission Meeting Minutes - Approvals and Enforcement

The Connecticut Commission of Pharmacy approved new pharmacy premises and several pharmacy remodels during its November 20, 2024 meeting. The Commission also initiated an enforcement action against Walgreens #02410 for alleged violations related to pharmacy manager changes and operating without a manager.