Laura Helbling

Latest From Laura Helbling
Medicare Proposes Earlier Deadline For Rx Add-On Payment Candidates
Starting in fiscal year 2025, products would need to meet an earlier, May deadline for FDA approval in order to be eligible for enhanced payments in the Hospital Inpatient Prospective Payment System (IPPS). The change would give CMS more to handle the surge in NTAP applications.
Drug Shortages Back In US Congressional Spotlight
Drug shortages were a significant focus of legislative attention in the US before the COVID-19 pandemic, and Congress is not likely to drop the issue now that the public health emergency is winding down.
House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval
US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.
Providers Still See Drawbacks To Opioid Education Mandates
Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.
Mandatory Prescriber Education For Opioids; Is This The Time?
US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.
US FDA Works To Stay Ahead Of Benzodiazepine Misuse
FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.