Prescription To OTC Switch

Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process. 

David Ball moves from Bayer’s North America business to be Perrigo’s first chief brand and digital officer. He joins CEO who also moved to Perrigo from Bayer with decades of branded product experience.

A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly. 

Germany's Expert Committee on Prescription recommends the Rx-to-OTC switch of an azelastine and fluticasone propionate combination nasal spray, the second time around. Low-cost smoking cessation drug cytisine, on the other hand, is denied - also the second time it has appeared before the committee.  

Agency used a 10-year average with updated figures to calculate FY2025 PDUFA application fee and limit impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.

Marketing authorizations for OTC medicines could be rejected if their environmental risk assessments do not meet new requirements proposed within the EU pharma legislation revision. HBW Insight speaks to regulatory law experts Tine Carmeliet and Eline D'Joos to find out what you need to know about the new rules.

The UK's consumer healthcare industry association, PAGB, sets out six priorities for the new UK government, following the landslide victory of the Labour Party in the recent general election. One of these priorities is driving Rx-to-OTC switch - something that the UK public also wants, according to the association's latest Self-Care Census, published to mark International Self-Care Day 2024.

Study with 509 subjects conducted in Petros’ preparation of OTC switch application demonstrated 90.6% correct self-selection for participants using its web app technology and DFL and 57.3% correct by subjects using only DFL.

The antihistamine cyproheptadine is no longer available as a non-prescription allergy treatment in France after regulator ANSM said it had been misused for years to induce weight gain for “aesthetic purposes.”

House and Senate reports again reference sunscreen but add admonishment that FDA “harmonize its approach with international testing standards.” Item exclusive to House report encourages guidance for drug firms on successfully submitting an application for Rx-to-OTC switch of an oral contraceptive.

“Despite there being a common regulatory framework for medicinal products in the European Union, there remains a diversity of approaches between EU member states with regards to how they regulate access to nonprescription medicines,” notes AESGP's Klavdija Kmetič, as the association updates its OTC ingredients directory.

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

Many positions are vacant or filled by individuals with ties to academia, industry or patient groups, representatives from public interest and consumer groups say during an FDA listening session on advisory committee reforms.

Emergent BioSolutions, Harm Reduction Therapetuics, Hikma, Teva and other drug manufacturers commit to increased supply of naloxone and nalmefene in meeting with ]White House Office of National Drug Control.

More than a year after the FDA created a new rule allowing hearing aids to be sold over the counter and directly to consumers, a government report finds the category has not yet made the impact many were expecting.

FDA asks for nominations for voting or non-voting consumer members of its advisory committees. Also wants to hear from consumer organizations interested in participating in selecting consumer representatives for its advisory committees or panels.

Real-world data and evidence, for example generated by digital consumer health technology like apps and wearables, could provide crucial support for Rx-to-OTC switch applications, argues Sanofi Consumer Healthcare’s Penny Glover at the Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium. Recent research by Sanofi indicates that regulators are actually already using RWD and RWE in many cases when assessing switch applications, even if they do not call it that.