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Shots - Health News
Tue June 11, 2013
Feds Cave On Emergency Contraception Age Restrictions
Originally published on Tue June 11, 2013 10:05 am
The Obama administration has gone to Plan C on Plan B.
Backed into a legal corner, the Justice Department said Monday it would drop its appeal of Judge Edward Korman's ruling last April that it make the morning-after birth control pill available over the counter with no age restrictions.
The action came five days after an appeals court refused to delay part of the judge's order while the appeal was being heard, effectively ordering some products, but not others, to be made available immediately.
With few other avenues of appeal, the Justice Department said it would instead obey the original order, sort of.
What the administration is now proposing is to have the makers of the most popular emergency contraceptive product – Plan B One Step – submit a new label allowing it to be sold over the counter without age restrictions. According to the letter the Justice Department sent to Judge Korman, when that application is received, "FDA will approve it without delay."
The letter warns, however, that the makers of Plan B One Step could be granted "marketing exclusivity," which presumably means a waiting period before generic copies could join the product on pharmacy and retail shelves.
And in a reversal of the situation that would have been created last week by the appeals court, the FDA says it "will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents." According to the government, "there are fewer data available regarding the actual use of Plan B" meaning the use of the two-pill product "as a nonprescription product by younger adolescents," compared to the one-pill product.
That means the two-pill products will remain prescription-only and behind the pharmacy counter for those younger than 17.
Still, advocates of easier access to the drugs were pleased by the administration's action.
"This decision by the Administration affirms what feminists have been fighting for all along – the Morning-After Pill should be available to females of all ages, on the shelf at any convenience store, just like aspirin or condoms," said Annie Tummino, the lead plaintiff in the long-running lawsuit.
Sen. Patty Murray, D-Wash., who had been pressuring the FDA to approve the pill for non-prescription sale for most of the last decade, said: "After far too long of a delay, science has prevailed."