Rx-to-OTC Switch

More medicines available without a prescription and more responsibility for community pharmacists are two of the goals set out by the UK's new Secretary of State for Health and Social Care.

Akorn agrees with DoJ to pay $7.9m to settle allegations it deliberately sold three as Rx three ingredients moved to OTC. Mislabeling led Medicare Part D to pay for the drugs for around a year despite the products not being eligible for coverage. 

“Who would have said that, looking forward two or three years ago, we would be where we are now?” says FDA OTC office director Theresa Michele. Monograph reform and introducing “additional conditions for nonprescription use” options for NDA OTCs each is a “real gamechanger.”

UK regulator MHRA has set out a proposal to raise fees across the board by at least 10% for its regulatory work related to medicines and medical devices. A select number of fees will see even bigger increases, with the cost almost tripling for Rx-to-OTC switch applications.

Health literacy and natural alternatives are two areas where Haleon's EMEA and LATAM head Filippo Lanzi sees potential for growth, in addition to Rx-to-OTC switch, he tells HBW Insight in an exclusive interview. Lanzi also digs deeper into Haleon's recently published first-half sales and earnings results and shares his thoughts on how the firm will meet the multiple challenges posed by the current social and economic environment. 

The first hormone replacement therapy drug sold without a prescription in the UK is now available in Boots pharmacies across the country.

In this episode, HBW Insight talks to Haleon’s global head of regulatory intelligence and policy, Ian Urquhart, about the innovative and flexible approaches that regulators took to ensuring access to medicines during the coronavirus pandemic. Urquhart speaks about his work with the Global Self-Care Federation, where the regulatory affairs committee which he chairs has been looking into what happened during the pandemic and drawing lessons for the future. Strengthening supply chains, Rx-to-OTC switch and e-commerce are all on the agenda for the organization, which has published a series of papers in these areas to inform future self-care policy and regulation across the world.

Periodic summaries FDA is considering are “most effective method to track and report relevant concerns,” but “failure” as outlined in proposed rule is too broad, says CHPA. Digital care delivery firm Amwell says FDA should ask ACNU OTC marketers for some individual adverse event reports in addition to summaries.