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Over-the-Counter Revolution

Earlier this month, FDA officials met with Barr Pharmaceuticals to discuss the drug company's application to make Plan B emergency contraception (EC) available over the counter.
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Planned Parenthood's helped generations of women prevent unintended pregnancy for 90 years -- and soon help could be on the way.

Earlier this month, FDA officials met with Barr Pharmaceuticals to discuss the drug company's application to make Plan B emergency contraception (EC) available over the counter. Not coincidentally, the meeting was announced just one day before Senate confirmation hearings for President Bush's embattled nominee for FDA commissioner, Dr. Andrew von Eschenbach, -- the agency's acting director since September 2005. Since then, there have been renewed rumblings that the FDA will soon rule on the application.

For decades, doctors nationwide -- disconnected from the political maneuvering in Washington, DC -- have safely prescribed EC to American women. And in many countries around the world, it's been available over the counter since 1999. Planned Parenthood, too, has provided EC to millions of women -- and advocated for Plan B to be made available in the U.S. without a prescription.

In the past decade, study after study has reaffirmed that EC is safe and effective, and that women use it responsibly. Planned Parenthood, the American College of Obstetricians and Gynecologists and other groups encouraged women to keep EC in their medicine cabinets -- just in case. Hospital emergency rooms began offering it to sexual assault survivors. More and more women and health care providers learned about EC. Planned Parenthood launched a major public education campaign with remarkable results. Demand for EC at our health centers skyrocketed from 17,000 in 1995 to more than a million prescriptions last year.

In 2003, Barr -- loaded with scientific evidence showing that Plan B meets all the criteria for over-the-counter status -- applied for the FDA to change Plan B's status from prescription-only to over the counter. The FDA's own blue-ribbon panels of experts solidly endorsed the move.

Good news, right? Not quite. Cut to today: Forty months later, women are still waiting. Under pressure from birth control opponents, the FDA has employed requests for additional information, solicited public comments on the application and used other stall tactics to essentially shelve the over-the-counter application. Meanwhile, there are approximately three million unintended pregnancies in our country every year. Studies show that approximately 1.5 million of these could be prevented by increased access to EC. And, tragically, teen pregnancy remains a nationwide epidemic.

But all hope is not lost. Senators Patty Murray (D-WA) and Hillary Clinton (D-NY) seized the opportunity of the von Eschenbach hearings to renew their call for an FDA that makes decisions based on science, not politics. Barr's over-the-counter application had languished on von Eschenbach's watch, after going nowhere under previous FDA commissioner Dr. Lester Crawford, who resigned abruptly two months after his Senate confirmation.

Making EC available over the counter matters. The sooner EC is taken, the better it works. Contraceptive failure doesn't always happen during business hours. When is the last time you tried to track down a doctor on Friday night at 11:00 p.m.?

Imagine a day when every woman has access to the information and services she needs to stay healthy and, if she chooses, to plan healthy, wanted pregnancies. A day when teens, too, have every chance to prevent unintended pregnancy, get an education and stay on track to fulfill their dreams. Comprehensive access to the full range of birth control options -- including EC -- would inevitably reduce the need for abortion. That's a commonsense goal supported by the overwhelming majority of Americans.

Achieving over-the-counter access to Plan B will be a major victory for women's health and the effort to prevent unintended pregnancy. That good news shouldn't exclude teens. The reality is that approximately 800,000 U.S. teens will get pregnant this year. Our country has one of the highest teen pregnancy rates in the developed world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine, bad policy -- and bad news. Unfortunately, the FDA's anticipated over-the-counter ruling will exclude teens -- a move that's unsupported by the scientific evidence and the FDA's own expert panels.

On Friday, Barr submitted its third application for Plan B to be made available to American women over the counter. And just yesterday, President Bush suggested that he supports increased access to EC. The FDA should not wait one more day to issue an over-the-counter ruling on Plan B. It should stick to sound science and make EC accessible to every woman who needs it. Imagine that. What a revolution it would be.

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