The Center takes the FDA Back to Court

Teva, the manufacturer of the emergency contraceptive (EC) Plan B, announced that it filed an application with the FDA requesting that EC be available over-the-counter without a prescription for women of all ages. When it comes to emergency contraception, the FDA has refused to listen to medical and scientific consensus that says there is no rationale for age restrictions. While the Center supports any action to increase access to EC, Teva’s application does not excuse the FDA of its responsibility to women and the law.

For more than a year and a half, the FDA and the Obama Administration has ignored a court order to reconsider its refusal to make emergency contraception available over-the-counter to women of all ages. The Center has given the FDA ample time to end its baseless restrictions, but as of today it has not taken any steps to comply with the court order.

Some Facts

The FDA has had a year and a half to remove the politically motivated age restriction and it has not done so.

Medical and scientific consensus provides no rationale for age restrictions on Plan B.

The Bush Administration did not want young women to have access to Plan B — an innovative, proven, and safe contraception.

More than 60 medical and citizen groups signed the Center's Citizen's Petition to the FDA stating that emergency contraception was safe, efficacious, and easy to administer — all three factors required by the FDA for over-the-counter medications.

The Center took the FDA back to court in November 2010 and is calling on supporters to write the FDA Commissioner to take immediate action to end restrictions on emergency contraception.

Help us make the case by telling the FDA to end age restrictions on emergency contraception immediately!

Take Action!

At the start of his administration, President Obama declared that politics would no longer play a role in U.S. science policy, stating, "we make scientific decisions based on facts, not ideology." And soon after FDA Commissioner Margaret Hamburg was confirmed, she told reporters that it was her mantra to make FDA's decisions more "science-based."

So in March 2009, when the court ruled that the FDA acted in "bad faith and in response to political pressure" when it repeatedly and unreasonably delayed making a decision on Plan B and departed in significant ways from its normal procedures, it thought the new administration would "conduct a fair assessment of the scientific evidence." This has obviously not happened, and the Center is returning to the courts to make sure the FDA complies with medical and scientific consensus that says there is no rationale for age restrictions to emergency contraception.

Background

The Center sued the FDA in 2005 for failing to grant over-the-counter status to emergency contraception (a.k.a Plan B) against the advice of its scientific experts and in violation of its own procedures and regulations. In 2006, the FDA agreed to make Plan B available without a prescription, but only to women 18 and over and only behind the pharmacy counter.

The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

In its decision, the Court found that the FDA “acted in bad faith and in response to political pressure,” “departed in significant ways from the agency’s normal procedures,” and engaged in “repeated and unreasonable delays.” In addition, the court found that the FDA’s justification for denying over-the-counter access to 17-year-olds “lacks all credibility,” and was based on “fanciful and wholly unsubstantiated ‘enforcement’ concerns.”

The Center for Reproductive Rights filed the lawsuit on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy, and parents who seek over-the-counter access for their daughters.

The Victory

On March 23, 2009, the Center scored a major victory when a federal court ruled that the U.S. Food and Drug Administration had put politics before women’s health when it decided to limit access to emergency contraception.

In its decision, the Court found that the FDA “acted in bad faith and in response to political pressure” and ordered the agency to go back and revisit the age and behind-the-counter restrictions to emergency contraception

Today, emergency contraception is available without a prescription, but only for women age 17 and older. Pharmacies and clinics must keep it behind the counter and anyone seeking to buy it must show government issued identification proving their age in order to buy it without a prescription.

These intrusive restrictions, unprecedented for drugs with over-the-counter status, make it harder and more stigmatizing for consumers to get the contraception during its most effective window.

Scientists and medical experts, including the FDA’s own scientific review panel, agree there are no medical grounds for denying young women access to emergency contraception. Expanding access to emergency contraception is the best decision for women’s health.

One Year Anniversary of the Decision

On March 23, 2010, the Center celebrated the victory in its case against the FDA but clearly noted that the agency was still dragging its feet to end restrictions on emergency contraception. To help us make the case that the restrictions were harmful and scientifically baseless, the Center produced an innovative video delivering the message that women need safe, quick access to EC and not confusion at the counter.

 


Resources

Tummino v. Margaret Hamburg: Memo of Law in Support of Plaintiffs Motion for Civil Contempt >

About the case Tummino v. von Eschenbach >

Federal Court Rules FDA Must Reconsider Plan B Decision > 

Read the Citizen's Petition >

Morning-After Pill Conspiracy: Interview with Annie Tummino >

RHTP: Emergency Contraception Information and Facts >

RHTP: Adolescents and Over-the-Counter Emergency Contraception >