Lupin 2023

CHPA comments on benefits of O-T-C switch for naloxone

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WASHINGTON — The Consumer Healthcare Products Association (CHPA) released the following statement in advance of FDA Advisory Committee meetings considering OTC access to naloxone:

“Over-the-counter (O-T-C) availability of naloxone – a life-saving emergency therapy for opioid overdoses that is currently only available with a prescription (Rx) – would be a critical step forward in public health and would provide benefits that Rx-to-O-T-C-switch products have always delivered: increased access to safe, effective, and affordable medicines for better healthcare.

“‘Access matters. It’s about time. It’s about place. It’s about removing barriers’, according to CHPA Senior Vice President of Legal, Government Affairs & Policy, David Spangler, speaking at the recent FDA joint advisory committee meeting. Making naloxone available O-T-C would allow anyone to purchase it without the need for a prescription, making it more widely available to those who need it. Since naloxone is used in emergency situations and every second counts, O-T-C access would give individuals, family, friends, and other responders quicker access to this medication, potentially saving more lives. Requiring a prescription to obtain naloxone presents a barrier for individuals who may be hesitant to ask healthcare providers for a prescription, potentially due to stigma or fear of repercussions. Making naloxone O-T-C could reduce these barriers and increase the likelihood that individuals will obtain and carry the medication.

“Since COVID-19, Americans have been demanding more options to empower self-care and naloxone is just one of several prescription medicines being considered for O-T-C switch. Unfortunately, the development and approval process for switches has become slower and less efficient and we encourage FDA to provide clearer, more timely feedback to sponsors to help this process. We are pleased to see FDA beginning to grant face-to-face meetings with sponsors and hope this expands in the near term. CHPA hopes FDA can move forward on the naloxone switch rapidly and can accelerate and strengthen the Rx-to-OTC switch process overall.”




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