Why nobody is happy with FDA ruling on Plan B

The Food and Drug Administration’s decision to lower the age of availability for the morning-after pill – but not eliminate restrictions altogether – has left nobody completely satisfied.  

On Tuesday, the FDA announced that the emergency contraceptive known as Plan B One-Step would now be available, without prescription, to females aged 15 and older. That represents a shift from the current regulation, which made the pill available without a prescription only to females aged 17 and above. The new rule also allows the pill to be sold on pharmacy shelves, instead of being locked behind a pharmacy counter.

The FDA’s move came in response to an amended application by the pill’s manufacturer, Teva Women’s Health, which was filed after a 2011 decision by the FDA to restrict access to Plan B One-Step to females aged 17 and older. Tuesday's announcement was not a response to a federal judge’s ruling on April 4, which ordered the pill be made available within 30 days for all ages and without a prescription. That deadline is next Monday.

The Department of Justice is considering next steps on the litigation, according to the FDA. If the Justice Department opts not to appeal the federal judge’s order, it remains unclear what would happen with the conflicting new FDA rule, which goes into effect immediately.

The issue has long been politically charged. In 2011, Health and Human Services Secretary Kathleen Sebelius set an age restriction of 17 years on access to the morning-after pill, despite an FDA determination that the drug was safe and effective for all ages.  

Reaction to the new FDA announcement from different actors in the longstanding debate over reproductive rights ranged from tepid support to outright hostility.

Cecile Richards, president of the Planned Parenthood Federation of America, called the new FDA rule “an important step forward to expand access to emergency contraception and for preventing unintended pregnancy.”

But, she added, “we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine.”

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