FDA pressed to go further on Plan B

{mosads}”The medical evidence demonstrates that [emergency contraception] is safe and effective in preventing pregnancy for all reproductive-age females,” the group said. “The College strongly encourages the FDA to reaffirm its earlier decision to approve [emergency contraception] for unrestricted [over-the-counter] access.”

Setting the age limit at 15 raises many of the same issues as setting it at 17 — namely, critics say, it’s not a decision that comes from a scientific evaluation of the drug’s risks and benefits.

The FDA in 2011 wanted to remove all age restrictions on Plan B, but was overruled by Health and Human Services Secretary Kathleen Sebelius.

Last month, a federal judge criticized Sebelius’s decision and said the drug should be available without age restrictions. The administration has not yet decided whether to appeal that ruling and emphasized that Tuesday’s change was not a response to the court’s decision.

The Center for Reproductive Rights, which filed the lawsuit against the FDA’s policy, said lowering the age to 15 doesn’t do enough to comply with the judge’s ruling.

“Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women — but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend,” said Nancy Northup, the group’s president and chief executive.

Keeping the age limit at 15 also raises new logistical issues because many teenagers don’t have government-issued identification until they turn 16 and begin driving. The FDA’s policy requires patients to prove their age before buying Plan B.