Healthcare News & Insights

HHS overrules FDA’s request to make Plan B available for all ages without prescription

Teva Pharmaceutical Industries Ltd.’s request to have its Plan B emergency contraceptive pill sold over the counter to customers of all ages was denied by Kathleen Sebelius, Secretary of Health and Human Services. 

Food and Drug Administration (FDA) Commissioner Margaret Hamburg said she was prepared to grant Teva’s request, until she received a note from Sebelius directing her to do the opposite.

The decision to overrule was based on the fact that girls as young as 11 years old were not included in a study of whether or not they could use the product safely.

Plan B One-Step, which is designed to be taken as soon as possible after intercourse and no more than 72 hours later, contains the hormone progestin. The drug is found in birth-control pills at a lower dose, and is designed to prevent ovulation and make the uterus less susceptible to a fertilized egg.

Currently, women 17 or older (with proper photo identification) can purchase Plan B One-Step over the counter, while girls under 17 need a prescription. In 2009, the age requirement to buy the drug without a prescription was reduced from 18 to 17. Prior to 2006, a prescription had to be issued for customers of all ages to obtain Plan B.

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