Less than 24 hours after the FDA announced that it would allow the Plan B contraceptive to be sold without a prescription to women as young as 15, the Justice Department filed a brief to stay the judicial directive that led to the action.
That is perhaps the longest sentence that I have ever written in a diary here. I have spent several hours reading about the issue and mulling it over in my head. The story is complicated, involves a few twists and turns, and has sparked some heated debate in support and opposition of access to the medication.
For those unfamiliar with Plan B, it is a "morning-after" pill that can stop pregnancy up to three days after intercourse.
Follow below the Orange Croissant and I will attempt to unpack the issues. Or, skip past and read Chris Weigant's take on it. After all, why should you listen to me.
(note: this diary addresses medication v. drug and women v. girls. I promise to be very careful how I use those terms but realize that they are fraught with potential danger. Any inconsistencies in the use of these terms is entirely my own and not the fault of the sources cited. Thank you in advance)
Some Background
HHS Secretary Kathleen Sebelius
Teva Pharmaceutical Industries Ltd., the manufacturer of Plan B, petitioned the FDA to remove the requirement that those under 17 be required to obtain a prescription to obtain the drug.
The FDA Commisioner was ready to comply with the request, calling Plan B "safe and effective in adolescent females," and saying that younger women could properly use the drug without the intervention of a doctor
HHS Secretary Kathleen Sebelius overruled the decision in December 2011.
The result of the FDA ruling would have removed the medication from behind the pharmacy counter and placed it in store aisles as well as removed any age restrictions to it's purchase.
"It is commonly understood that there are significant behavioral and cognitive differences between older and adolescent girls and the youngest girls of reproductive age which I believe are relevant to making this determination"
(letter from Kathleen Sebelius to FDA Commissioner Margaret Hamburg)
In addition to two studies supplied by Teva to support it's claim, the FDA conducted it's own reviews by pediatricians and obstetricians. Both the studies and the review determined that the drug was safe enough to remove the previously instituted restrictions.
Needless to say, the whole issue wound up in federal court.
The Lawsuit
Judge Edward Korman ruled that the action taken by Sebelius be reversed, calling it “politically motivated, scientifically unjustified, and contrary to agency precedent.” (
PDF) Korman gave the Federal government 30 days to reverse it's position.
The case was Tummino v. Hammond.
Plaintiff(s): Annie Tummino; Erin T. Mahoney; Carol Giardina; Kelly Mangan; Stephanie Seguin; Lori Tinney; Jennifer Brown; Candace Churchill; and Francie Hunt; Association of Reproductive Health Professionals; and National Latina Institute for Reproductive Health.
“This decision is a welcome advance and 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. Women and girls should have the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission.”
(Annie Tummino, lead plaintiff in the case)
Administration Reactions
After 25 days, the FDA announced that it would allow women aged 15 and older to buy Plan B without a prescription but with proof of age. The decision would also keep Plan B behind pharmacy counters.
But, as opposition to the ruling began to roll out, the Justice Department filed notice yesterday that it would appeal Korman's ruling. According to the DoJ, the action to allow 15 year olds to purchase the medication would not be affected.
“The Court’s Order interferes with and thereby undermines the regulatory procedures governing FDA’s drug approval process,” the Justice Department said. “A drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions.”
So, What Does This All Mean For The Future Availability Of Plan B?
Your guess is as good as mine. I will take your suggestions off the air ...
