Skip to main content

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 ...

EMAIL TO A FRIEND X
Your Email has been sent.
You must add at least one tag to this diary before publishing it.

Add keywords that describe this diary. Separate multiple keywords with commas.
Tagging tips - Search For Tags - Browse For Tags

?

More Tagging tips:

A tag is a way to search for this diary. If someone is searching for "Barack Obama," is this a diary they'd be trying to find?

Use a person's full name, without any title. Senator Obama may become President Obama, and Michelle Obama might run for office.

If your diary covers an election or elected official, use election tags, which are generally the state abbreviation followed by the office. CA-01 is the first district House seat. CA-Sen covers both senate races. NY-GOV covers the New York governor's race.

Tags do not compound: that is, "education reform" is a completely different tag from "education". A tag like "reform" alone is probably not meaningful.

Consider if one or more of these tags fits your diary: Civil Rights, Community, Congress, Culture, Economy, Education, Elections, Energy, Environment, Health Care, International, Labor, Law, Media, Meta, National Security, Science, Transportation, or White House. If your diary is specific to a state, consider adding the state (California, Texas, etc). Keep in mind, though, that there are many wonderful and important diaries that don't fit in any of these tags. Don't worry if yours doesn't.

You can add a private note to this diary when hotlisting it:
Are you sure you want to remove this diary from your hotlist?
Are you sure you want to remove your recommendation? You can only recommend a diary once, so you will not be able to re-recommend it afterwards.
Rescue this diary, and add a note:
Are you sure you want to remove this diary from Rescue?
Choose where to republish this diary. The diary will be added to the queue for that group. Publish it from the queue to make it appear.

You must be a member of a group to use this feature.

Add a quick update to your diary without changing the diary itself:
Are you sure you want to remove this diary?
(The diary will be removed from the site and returned to your drafts for further editing.)
(The diary will be removed.)
Are you sure you want to save these changes to the published diary?

Comment Preferences

Subscribe or Donate to support Daily Kos.

Click here for the mobile view of the site