Group weighs push to switch the pill OTC
This article was originally published in The Tan Sheet
Executive Summary
A coalition of women's health experts hopes to meet with FDA "in the next few months to discuss the regulatory pathway" for a potential OTC switch of oral contraceptives. Ibis Reproductive Health, which coordinates the Oral Contraceptives Over-the-Counter Working Group, said July 9 it is interested in moving oral contraceptives OTC "as a way to increase access to ECs especially for women who now face barriers to access." Ibis said the coalition is talking with potential partners about what regulatory and research milestones must be reached to switch the prescription drugs and is working to ensure that research needed for a switch, including label comprehension and actual use studies, will address broader questions about women's access to and information about the full range of contraceptive methods. The coalition, which first met in 2004, also is working to change Medicaid policy to cover all OTC contraceptive methods
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.