What a frustrating week in the ongoing battle over evidence-based health policy.
To the surprise and disappointment of women’s health advocates, the U.S. Justice Department on Wednesday filed an appeal to prevent girls under age 15 from gaining over-the-counter access to emergency contraception.
Approaching the date U.S. District Judge Edward Korman’s order making levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) available without restrictions would go into effect, the Obama administration also requested a stay pending appeal, meaning the judge’s order would not be implemented according to schedule.
The judge’s ruling last month was in response to the Center for Reproductive Rights’ renewed lawsuit seeking over-the-counter access to the morning-after pill.
Responding to the appeal, Nancy Northrup, CRR president and CEO, said in a statement:
Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations. The federal court has made clear that these stalling tactics were based purely on politics, not science.
We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.
In the appeal documents, the administration argues that the court overstepped its authority and improperly interfered with the rulemaking process; the judge should have instead sent the issue back to the FDA for further action.
“We aren’t focused in this appeal on the merits of the secretary’s decision,” a Justice Department official, who spoke on condition of anonymity, told The New York Times. “What we’re focused on is that the remedies that the judge ordered were beyond his authority.”
Ironically, overstepping is what many would argue the administration did in 2011 when HHS Secretary Kathleen Sebelius overturned a decision by FDA scientists to make the contraceptive pills available without restriction.
The administration also argues that since the actual plaintiffs in the case are all over age 15, and it’s not a class action suit, that no harm is done to the plaintiffs by granting the stay (see below). By making this argument, the administration avoids addressing the potential harm to girls who are prevented from accessing a drug both FDA scientists, and the judge, said should be available.
The administration claims that the public would suffer irreparable harm if the stay is not granted; if the ruling is allowed to go forward and later overturned, it would create confusion for women, who might “mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.”
We’re also supposed to believe the appeal has nothing to do with politics. A Justice Department official told The New York Times: “This is a decision that the Justice Department is making in representing our client: FDA. This is not a political decision. It’s not had White House intervention or involvement. This in our judgment is the right legal step to take in this case.”
Meanwhile, FDA Approves Making Plan B Available to Teens Age 15 and Up
The decision to appeal came just one day after the FDA announced its approval of Plan B One-Step emergency contraception pills without a prescription for teens age 15 and older. The drug was previously only available without a prescription to women 17 and older.
It’s a great step forward; however, younger women, for whom access to a healthcare provider may be most difficult, are still left without prescription-free access to the drug, which must be used within a limited window.
The FDA adds to the burden by specifically requiring proof of age. From the FDA’s press release:
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
The ID/proof of age requirement is a big hurdle for many teens. Many states set an age requirement of 16 for a driver’s license or learner’s permit. Obtaining a state ID (related to driving or not) costs money, and hours for doing so are often limited. And undocumented teenagers are unable to obtain a legal ID at any age.
“While welcomed by some as an acceptable compromise,” said Nancy Stanwood, Physicians for Reproductive Health board chair-elect, the “FDA decision to approve the sale of emergency contraceptive Plan B One-Step to those 15 years and older with government-issued identification does little to improve real access for already-vulnerable women and young teens. Plan B has a time limit, and too many women in the U.S. have gone without it because of unfair, unnecessary, and medically unjustified barriers to access.”
Writing at ThinkProgress, Tara Culp-Ressler explains other reasons why the policy shift is still problematic, noting in part that it simply isn’t based on science, and the high cost remains a barrier.
The FDA’s ruling was in response to an amended application request by Teva Women’s Health, the company that makes Plan B One-Step, to make the drug available without a prescription to women age 15 and older. The FDA in 2011 denied Teva’s application to make Plan B One-Step available for all females of reproductive age. And still the debate goes on.