FDA's Plan B Ruling Doesn't End Battle for Access

(WOMENSENEWS)–Former FDA Commissioner Lester Crawford pleaded guilty last week to conflict of interest and falsely reporting information about stocks he owned in companies that he was in charge of regulating.

Unfortunately, the coverage said little about what reproductive rights activists think was the real problem: that he served as hand-picked "staller in chief" on the morning-after-pill until he was forced out on the conflict charges.

In August, as Crawford’s problems were becoming more obvious, the Food and Drug Administration finally decided to make the morning-after pill (brand name Plan B) available without prescription to women 18 and older. Crawford stepped down in the fall of 2005, and since then Andrew von Eschenbach has been acting commissioner.

The decision, which takes effect in January, represents a major victory that women’s rights activists should rightfully claim. Since the Bush administration has been consistently anti-birth control, this is an advance under adverse conditions.

But it is not the end of the battles.

In over 38 other countries Plan B is available without a prescription and is treated with the same regulations as cold medicine and eye drops. You just buy it at the store; no questions asked.

If Plan B were granted full over-the-counter status in this country, it would be on the shelf at gas stations and grocery stores. Instead, it is trapped behind the counter, where pharmacists will be obliged to screen for proof of age.

According to a story published by the Associated Press, the FDA goes so far as to make Barr Laboratories, the makers of Plan B, promise to hire "secret shoppers" to ensure pharmacists are enforcing the age limit.

No ID, no birth control. At the FDA hearings on Plan B, one panelist said it was safer than aspirin. Last time I checked, I don’t need to show an ID to get aspirin.

Lead Plaintiff

I am lead plaintiff in a lawsuit (Tummino v. von Eschenbach) charging the FDA with applying a sexist double standard to Plan B for imposing an age restriction that it does not apply to other drugs.

My boyfriend doesn’t need to show an ID to buy condoms. Why are women restricted from buying birth control that women in 38 other countries can get as easily as shampoo?

This suit is moving forward and challenging the age restriction the FDA has proposed.

Given that Plan B is most effective when taken within 24 hours after sex, women of all ages need immediate access to it. And none of us should have to answer humiliating questions about our sex life in a drugstore line.

The American Academy of Pediatrics, the American Medical Association and the FDA’s own scientists all agree.

The Morning-After Pill Conspiracy, a coalition of activists working on this issue, is sponsoring an action in New York City on Nov. 4. In addition, local groups around the country will be urging people to call the FDA to express their opposition to the restrictions being placed on the pill.

Whoever can join us will help send a message to lawmakers that women want nothing less than full access to birth control and abortion, rights that the White House has been trying to take away or block for years.

Contraceptive Coverage Scrapped

In Bush’s first budget to Congress in April 2001 he scrapped the provision requiring insurance companies to cover contraceptives for 9 million federal employees (something House democrats later reinstated).

His administration also blocked U.S. grants to family-planning groups that provide contraceptive and abortion services–and even family planning counseling–overseas.

Bush is also an ardent supporter of abstinence-only education programs, which prohibit even the discussion of contraception. And he has appointed numerous officials with anti-birth control records to high level scientific, health and judicial positions, which brings us to the story on Plan B.

The FDA’s advisory committee voted for over-the-counter sales of Plan B for all ages in December 2003. However, the agency ignored its own experts, citing concerns about young women’s use of the pill and effectively sidelining the matter.

Some women’s groups, though, worked tenaciously to apply grassroots and legal pressure to end the FDA’s three-year stall.

In 2003 the Gainesville Area National Organization for Women and Gainesville Women’s Liberation–two groups from Florida–worked with the Women’s Liberation Birth Control Project and Redstockings Allies and Veterans, based in New York City, to organize everyday women to testify at the FDA’s public hearings in Washington on Plan B.

Women testified about the hassles they experienced trying to get the morning-after pill under the burdensome prescription requirement. They argued that as women who had taken or needed the morning-after pill, they qualified as experts on the matter. These brave testimonies and the efforts women made to deliver them–some drove 14 hours to reach the hearing–proved that women were not giving up.

I was not among those who testified, but I have personal stories to tell about Plan B access all the same. One morning I panicked because my doctor’s office was closed and I didn’t have time to wait at a clinic; luckily I found a hotline that called it in for me. Another time I wasn’t able to get it because I was camping in the woods. Luckily I didn’t get pregnant, but I was outraged that I didn’t have more control over my reproductive decisions.

Demonstrations and Rallies

The National Organization for Women passed a resolution in 2003 calling for a national day of speak-outs on the morning-after pill and women in New York and Gainesville, Fla., held demonstrations and rallies.

Because the FDA knew it would have to answer to these women, in February 2004 the FDA did not reject the Plan B application as the White House might have desired. Instead, the agency issued a delay.

That’s when activists on this issue formed the Morning-After Pill Conspiracy to serve as a national coalition. I was just getting involved, but I wasn’t in the decision-making process yet. We began passing out morning-after pills at public demonstrations, committing civil disobedience by defying what they saw as an unjust prescription requirement.

In January 2005, nine Morning-After Pill Conspiracy women, including myself, were arrested in a sit-in at FDA headquarters. We said we were blocking access to the FDA because the agency was blocking millions of women’s access to birth control.

Several of us joined a lawsuit against the FDA regarding their refusal to put the morning-after pill over-the-counter. The suit charges the FDA commissioner with ignoring scientific fact and holding Plan B to a different standard than other over-the-counter drugs, consequently breaking the FDA’s rules and regulations. Our claims are backed up by a November 2005 report from the Government Accountability Office that found the FDA considered 68 proposals to switch prescription drugs to over-the-counter status between 1994 and 2004, and followed the recommendations of its advisory committee in every case except for the Plan B application.

Encouraged by our activism, U.S. senators such as Hillary Rodham Clinton and Patty Murray held up von Eschenbach’s nomination to head the FDA. Just as the lawsuit was uncovering evidence of White House influence on FDA decision-making, the agency caved. On Aug. 24 the FDA finally ruled that Plan B could be sold without a prescription for women 18 years and older.

But that shouldn’t fool any of us into thinking the battle is over. In fact, we got a long way to go. The good news is that the feminist movement has shown it can make an impact.

Annie Tummino is lead plaintiff in Tummino v. von Eschenbach, a suit charging the FDA Commissioner with sex discrimination, and chair of the Women’s Liberation Birth Control Project in New York City.

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