Plan B for 'Plan B'

National | HEALTH: Sexual irresponsibility among teens provides a huge market for pharmaceutical firms peddling morning-after pills. For now, the FDA has said no to creating an even more lucrative over-the-counter market for the "Plan B" drug. But the issue is far from over

Issue: "Iraq: The image war," May 22, 2004

For the pro-abortion lobby, it was a bitter pill to swallow: On May 7, acting against the advice of its own scientific bureaucracy, the Food and Drug Administration quashed a proposal to sell morning-after contraception without a doctor's prescription.

Liberal women's groups accused the FDA of caving to political pressure. "This decision proves once again the Bush administration is a lot of conservative and not much compassion," said Elizabeth Cavendish, interim president of NARAL Pro-Choice America. Conservatives, meanwhile, were stunned by a victory that no one had seen coming. After a scientific advisory committee voted 23-4 in favor of approval last December, over-the-counter (OTC) sales of the "Plan B" morning-after pill seemed all but guaranteed-that is, until Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, intervened.

"You propose OTC status for Plan B for both adults and children based primarily on an actual-use study in 585 subjects," Dr. Galson wrote in his controversial "nonapproval letter" to Barr Laboratories, the maker of the drug. "Only 29 of the 585 subjects enrolled in the study were 14-16 years of age, and none was under 14 years of age." Based on a lack of data on the safety of Plan B for young teens, Dr. Galson said, he could not approve distribution of the drug without a prescription.

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In the wake of an uproar by the abortion lobby and newspaper editors across the country, Dr. Galson quickly denied charges he had acted at the behest of the White House. His decision, he said, was based on concerns that nonprescription access to Plan B for teens would increase the spread of sexually transmitted diseases.

Despite those concerns, however, Plan B's confinement to prescription-only purgatory is almost certainly temporary. In his letter to Barr, Dr. Galson expressed support for Plan B's OTC future-and laid out in detail two ways Barr can make that future happen.

Plan A: Provide a "safety update" on the use of the drug by girls ages 11 to 15. Scientific, yes, but a steep, lengthy, and expensive climb that would require the pharmaceutical firm to assemble and tabulate new safety data; detailed information on Plan B-related injury, illness, and death in the target age group; and "a summary of worldwide experience on the safety of this drug."

The second and more likely option for Plan B is, well ... Plan B: Create a dual marketing scheme in which the drug would be made available OTC to girls and women age 16 and above, while girls 15 and younger would require a prescription. That's anathema to groups like NARAL, which insist for ideological reasons that young teens be treated as full-grown women.

For Barr Laboratories, however, partial OTC approval would be much better than none at all. Analysts had projected that OTC Plan B sales could generate revenues of $25 million to $35 million, with some outer-edge estimates of up to $100 million. Already among the top 10 independent pharmaceutical companies in the United States, that kind of cash could vault the company over the billion-dollar annual threshold, nearer the industry's elite. Even without OTC sales, the company attributes part of its recent 87 percent revenue growth to its February acquisition of Women's Capital Corporation (WCC), which had held the rights to Plan B.

While Planned Parenthood and other teen-sex industry leaders have promoted emergency contraception as essential to female "reproductive health," WCC clearly marketed Plan B as a lifestyle drug, a kind of golden ticket to sex without consequences:

Newspaper ad: "Delta Delta Thi. 27 Upstanding Young Men. 34 Billion Sneaky Little Sperm."

Newspaper ad: "So Many Men. So Many Reasons to Have Back-up Contraception."

Billboard poster: "A Renaissance Man, A Deep Thinker, An Ancient Soul, A Walking Sperm Factory."

Ads like those helped generate some 1.5 million prescriptions for Plan B last year, and OTC sales would be exponentially more lucrative. "This is what the owner of Plan B did when the drug was still available by prescription," said Wendy Wright, senior policy director for Concerned Women for America. "If this is how tasteless and irresponsible their ads have been in the past, we can expect to see even worse if the drug is made available over the counter."

Ms. Wright is concerned that if Barr is successful in getting Plan B approved for OTC sales, even if only to adults, young girls will still be at risk. "You can't be sure that the buyer will be the consumer," said Ms. Wright, who in December testified before the FDA on Plan B's risks to adolescents. "An 18-year-old clerk can sell it to a 17-year-old boy who gives it to his 15-year-old girlfriend."


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