Rx-to-OTC Switch

One way to revitalize interest in the EU's centralized switch procedure would be to introduce longer data exclusivity periods or market exclusivity for successful applicants, concluded an AESGP expert switch panel presenting at the association's 59th Annual Meeting in Paris, France. However, a European Commission representative told another panel that this was not under consideration as part of the EU pharmaceutical legislation revision.

Approval likely would account for all weight on scale of FDA decision if not for self-report element in design of HRA Pharma’s actual use study for OTC switch of 0.075-mg norgestrel branded Opill. HRA’s sNDA offers lesson for using electronic diary apps in self-report studies.

The European Commission shocked participants at this year's AESGP Annual Meeting by warning that OTC antifungals, like treatments for athlete’s foot, and OTC antivirals, like cold sore creams, could soon become prescription-only within the region, under proposed revisions to the EU pharma legislation. There is hope, however. The proposals are still open to feedback from industry, the AESGP points out, and even if this proposal becomes law, member states can waive this prescription requirement under certain conditions.

HBW Insight catches up with US executive editor, Malcolm Spicer, to discuss Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch application for its daily contraceptive, Opill. With the switch currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on his in depth coverage of the subject, as well as his extensive experience writing about the US consumer health market, to tell listeners what they need to know about this historic switch.

NDAC and ORUDAC members acknowledged the FDA’s concerns about some data provided by Opill sponsor HRA Pharma to support its OTC switch application. However, a greater share noted the “historic nature” of the proposal and the broad support expressed in the meeting’s public comment portion.

Maxwellia’s application to switch to non-prescription status in the UK Aquiette (oxybutynin hydrochloride) for the treatment of overactive bladder has been rejected by MHRA following a public consultation.

Wait will be as long as another three months to learn whether HRA will have approval to market OTC a product Perrigo estimates will have $100m in annual sales.

FDA officials again made clear concerns about “improbable dosing” data in HRA’s sNDA for 0.075-mg norgestrel tablet branded Opill before advisory panel voted at close of a two-day meeting conducted 60 years after first Rx oral contraceptive approved in US.