Science, Politics, and Over-the-Counter Emergency Contraception
- Author Affiliation: Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ADOLESCENT
- AGE FACTORS
- CONTRACEPTIVE AGENTS
- DRUGS, GENERIC
- EMERGENCY TREATMENT
- GOVERNMENT REGULATION
- HEALTH POLICY
- HEALTH SERVICES ACCESSIBILITY
- HEALTHCARE DISPARITIES
- LEVONORGESTREL
- PHARMACISTS
- POLITICS
- POVERTY AREAS
- PREGNANCY IN ADOLESCENCE
- PREGNANCY, UNWANTED
- SOCIOECONOMIC FACTORS
- UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES
- UNITED STATES FOOD AND DRUG ADMINISTRATION
On December 7, 2011, Health and Human Services Secretary Kathleen Sebelius overruled the US Food and Drug Administration's (FDA’s) decision that levonorgestrel emergency contraception (sold under the brand name Plan B One-Step) was safe and effective for all women of childbearing potential, regardless of their age, and should be approved for sale as a nonprescription drug. Plan B One-Step is a single-dose 1.5-mg tablet of levonorgestrel that should be taken as soon as possible and within 72 hours after an episode of unprotected intercourse.
Emphasizing a concern about nonprescription use by the youngest girls of reproductive age, Sebelius wrote to Margaret Hamburg, MD, the FDA commissioner that the studies submitted to the agency “do not include data on all ages for which the drug would be approved and available over the counter” and “do not establish that prescription dispensing requirements should be eliminated for all ages.”1 Although the Health …
