Rx-to-OTC Switch

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

Even at conservative estimates, switching an additional 97 molecules could save about €200m, according to France's consumer health industry association.

Biden’s order for proposed rules could boost support for Democrat Kamla Harris from undecided voters concerned about reproductive rights or for Republican Donald Trump from those who agree with his conservative stance on access to birth control, which he argues should be up to states to regulate. Proposed rules also could stir consumers not planning to vote to go to the polls.

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

UK consumer healthcare industry association PAGB is calling on the UK government to explore the Rx-to-OTC switch of at least 25 OTC products over five years, and work with the country's medicines agency to re-evaluate the restrictive criteria for reclassification. 

In addition to commentary and information about the OTC drug, dietary supplement and cosmetic industries, speakers offered candid remarks on subjects well known across the consumer health industry or well recognized by consumers.

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

An end to litigation filed by institutional investors, insurance companies and pension funds comes four CEOs after Perrigo's chief exec during Mylan's tender in 2015, Joseph Papa, resigned to lead another firm in 2016. Plaintiff attorneys are asking for up to 20% of settlement in fees.

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.