Surgeon and author Jeffrey A. Singer discusses his article "The FDA's outdated prescription rules are failing women and opioid users." He argues that the U.S. Food and Drug Administration's requirement for prescriptions for certain safe medications, specifically hormonal contraceptives and the opioid antidote naloxone, creates significant barriers to access and reflects outdated paternalism. Jeffrey highlights that obtaining prescriptions for birth control pills adds cost and inconvenience, disproportionately affecting women who report difficulty accessing appointments, despite decades of recommendations from major medical groups like the American College of Obstetrics and Gynecology and the American Medical Association for over-the-counter access, a standard in over 100 countries. He critiques the FDA's slow and partial move to allow only one type of progestin-only "mini-pill" over-the-counter, contrasting it with the easier access to emergency contraception. Similarly, Jeffrey discusses the years-long delay in making naloxone available over-the-counter, despite its proven safety, effectiveness by laypeople, availability in other countries, and requests from experts and even the FDA itself, noting how manufacturer financial incentives and state-level workarounds preceded the eventual, partial FDA approval for the nasal spray form.

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Why the FDA's outdated prescription rules hinder access to birth control and naloxone

The Podcast by KevinMD