Washington Post – The Food and Drug Administration announced late Tuesday afternoon that it had approved a drugmaker’s application to sell the emergency contraceptive Plan B One-Step over-the-counter to women 15 and older.
This is not, as the FDA points out in a statement, a response to the recent court decision on emergency contraceptives. In that April 5 case, a federal judge ordered the Obama administration to make Plan B available over the counter to women of all ages — not just those who are 15 and older.
“The Department of Justice is considering next steps in the litigation,” FDA officials said in a statement. “In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.”
We don’t know yet whether the Department of Justice will file an appeal to the court decision, but we will know soon: The Obama administration only has until May 5 to do so.
If the federal government does not appeal and does comply with the federal court ruling, it would make this FDA rule, in a way, moot. Under that scenario, the FDA would agree to allow emergency contraceptives to be sold without any age verification.
If Justice goes the other route, and appeals the court decision, then this policy would have a lot more meaning. It would liberalize access to emergency contraceptives for women of all ages by making Plan B One-Step available in situations when a drug store may be open — but it’s pharmacy is closed.
As to how stores will verify age, the FDA will require the product be come with this label: “Not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.”
The product will also, according to the FDA, “be packaged with a product code prompting a cashier to request and verify the customer’s age.”
Minors could use a driver’s license or permit for age verification purposes. If those documents are not available, other forms of identification would also qualify.
“A 15-year-old can use an alternative form of ID to verify their age — for example, a passport or birth certificate,” FDA spokeswoman Stephanie Yao said. “If a 15-year-old is unable to verify their age, they will not be able to purchase Plan B One-Step.”
Women’s health groups quickly supported the decision, while also urging the federal government to adopt policies that would allow even wider access to emergency contraceptives.
“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception,” Planned Parenthood President Cecile Richards said in a statement.
0 Comments