WHEN PHARMACEUTICAL companies refused to market the abortion-inducing drug in the United States, a group was formed to navigate the maze of regulatory conditions and manufacturing responsibilities. What grew out of the successful efforts of the coalition was a secret company dedicated just to the making and sales of one drug.
The long and tangled journey of the abortion pill to the United States--expected to culminate with its introduction here this month--began with the zeal of two women, who marshaled a force of moneyed activists to do for themselves what the major pharmaceutical companies would not.
In a highly unusual twist on the way most medications find their way to market, this cobbled-together group took on roles usually reserved for corporate executives and marketing experts, picking their way through the minefields of abortion politics to win federal approval this fall of the drug compound, mifepristone, commonly known as RU-486.
The pill's 11-year journey to the United States included a cloak-and-dagger scheme to hide the identities of participants from anti-abortion activists; allegations of fraud; a dozen lawsuits; and a cost of at least $50 million.
The company set up to distribute the drug, Danco Laboratories, has gone through four incarnations and at one point was registered as an offshore enterprise. Citing fear that anti-abortion activists might foment violence against those who make and distribute the drug, Danco refuses to release the names of its executives and investors. The company even persuaded the Food and Drug Administration to keep secret the location of the factory where the abortion drug will be produced, despite several published reports that it will be made in bulk at the state-owned Hua Lian Pharmaceutical in Shanghai.
But the real story goes beyond all that. It is what happens when a group of true believers finds the financial means and the political support to use the private sector to its own ends.
A coalition forms
Longtime feminist activists Peg Yorkin and Eleanor Smeal; scientists at the nonprofit Population Council; liberal organizations such as the David and Lucille Packard Foundation; abortion-rights activists; and even the president of the United States all played a part.
"What united us, the interested individuals and nonprofits and foundations, was the desire to make this very safe, early option available for women," said Sarah Clark, who directs the population program for the Packard Foundation. "Abortion is such a toxic subject that the ordinary channels for this drug were not available."
The existence of the coalition--and its ultimate success on Sept. 28 when the FDA approved mifepristone for use in the United States--has confounded and outraged abortion opponents.
"It's a whole movement to try to transform the image of abortion," said Randall K. O'Bannon, director of education and research for the National Right to Life Committee. "To make it from something that's intimidating and invasive, to make it into just a pill to make the baby go away."
It was 1989 when Smeal, a former president of the National Organization for Women, and Yorkin, a Hollywood producer with a history of putting her money behind feminist projects, took 700,000 petitions and a team of scientists to France, where mifepristone, then known as RU-486, had been on the market for about a year.
Their goal: to find out whether or not it really worked and to persuade the compound's French manufacturer, Roussel Uclaf, to sell it in the United States.
"We had a formidable challenge," Smeal recalled.
For many feminists, the drug represented an opportunity to make abortion safer, more private and more accessible. It would, to their thinking, disperse the ability to perform abortions throughout the medical community, thwarting anti-abortion activists who often focus their attention on clinics or on publicly identifying doctors who perform abortions.
But the Catholic Church in France had mounted a huge lobbying campaign against the drug, as had anti-abortion forces in the United States. The new corporate owners of Roussel Uclaf, German-based Hoechst AG, wanted nothing to do with the messy, sometimes violent, politics of abortion in America, and in 1988, it even tried to pull RU-486 off the market in France after protests there. But the Ministry of Health forbade it, and now it is used in about a third of French abortions.
"We're going to have to do it ourselves," Smeal told Yorkin. Then they set about thinking of how that might be done.
Yorkin put up the first big chunk of money--$10 million to the Feminist Majority Foundation, an organization founded two years earlier by herself and Smeal. Much of the money, Yorkin said, was earmarked for the abortion pill.
"You get to be players at the table if you have the money to do it," she said. "But it's taken so long, I was beginning to wonder if it would happen in my lifetime."
Along with Katherine Spillar, who runs the Feminist Majority's West Coast operations and is based in Los Angeles, Smeal and Yorkin launched an information blitz aimed at abortion-rights activists, feminists and others who might have an interest in the drug. The group lobbied heavily in Washington, where the FDA, under then-President Bush, had put the pill on a list of medications banned from entering the United States. The group also continued to lobby Roussel Uclaf and Hoechst, pleading with executives to cede or sell the rights to the drug in the United States if it did not intend to introduce it here.
Administration pitches in
Their big break came early in 1993, when newly elected President Clinton, on his third day in office, directed the Department of Health and Human Services to "promote the testing, licensing and manufacturing in the U.S. of mifepristone."
Soon after, the administration began its own efforts to persuade Roussel Uclaf to either bring the drug to the United States or give up its patent rights here.
At one point, Health and Human Services Secretary Donna Shalala intervened personally, phoning company officials and asking them to cooperate.
By the next year, the deal was done. The company gave the patent on mifepristone to the Population Council, a family planning think tank in New York. The organization employs dozens of scientists worldwide to investigate and develop new forms of contraception and had twice been instrumental in finding investors to market controversial products.
It got the patent transferred in 1994. But then the job got harder.
Clinical trials of the drug had to be conducted in the United States, even though it had already been tested and approved in France, to get federal approval. And once it was approved, someone had to agree to market and manufacture it.
Moreover, the National Right to Life Committee and about 30 supporting organizations started a boycott of Roussel Uclaf and Hoechst for giving the Population Council the patent rights.
"We sent over a delegation to Roussel Uclaf and to Hoechst," O'Bannon said. "We told them we did not want this pill imported to the United States. And they were told that if they did anything to make it available in the United States, they would be held accountable."
In the end, Roussel Uclaf and Hoechst gave away their patent rights for France and the rest of Europe. And in the United States, not a single pharmaceutical company stepped up to the plate to help research, make or manufacture the drug.
The Population Council raised $16 million from like-minded foundations, including the Open Society Institute of New York, which is the philanthropic arm of billionaire George Soros, and the California-based Kaiser Family Foundation.
The money was used to conduct new trials of the drug and to prepare the thousands of pages of documents necessary to win FDA approval. Population Council researchers began clinical trials in October 1994, just five months after Roussel Uclaf ceded the patent.
In the midst of the FDA approval process in 1997, an unidentified company that had been hired to manufacture the drug backed out.
With a federal deadline for finding a manufacturer looming, Danco Laboratories moved quickly to sign up another manufacturer, Dutch pharmaceutical company Gedeon Richter.
At the last minute, that company also backed out.
Key players sign on
Finally, in 1998, Danco received $10 million from the Packard Foundation. Months before, the company had hired Roy Karnovsky, a 20-year marketing veteran of pharmaceutical giant Merck, as its new president.
Dr. Richard Hausknecht, an obstetrician at Mt. Sinai Medical Center in New York who specializes in abortion, signed on as medical director.
"I came to it primarily out of conviction," said Hausknecht, who had been involved in the abortion-rights movement for years and had published a paper on a different drug sometimes used to induce abortion. "I had an enormous amount of experience with medical abortion ... [and] I was at a point in my career where the anti-choice people were less in a position to do damage to my practice."
Danco's only other publicly identified employee, public affairs director Heather O'Neill, was fresh out of graduate school at Harvard and had been an intern at the Population Council. She too had joined the organization more out of personal conviction than a search for career advancement.
The little company went to work in its unmarked Midtown Manhattan offices, determined to see the process through.
It hired a manufacturer--reportedly Hua Lian Pharmaceutical --to make the compound in bulk and an undisclosed U.S. company to shape it into pills, although no one at Danco will confirm that and the name has been sealed on FDA documents.
And it developed a marketing plan.
At last, despite cries of foul and accusations of conspiracy from the anti-abortion community, the FDA approved the pill for use in the United States on Sept. 28.
In a strange twist, the FDA acceded to Danco's request that the name of its manufacturer be kept secret--and even shielded the names of the FDA researchers who had overseen the pill's approval.
"We looked at the sorts of issues that this product raises and some of the threats and violence that have occurred around the issue of reproductive rights," an agency spokesman said.
The FDA considered the personal safety of employees at the pharmaceutical plants producing mifepristone, as well as the effect of potentially violent protests on a manufacturer's business, he said.
"If something were to happen to a manufacturing facility, it could put the company out of business," he said.
Even FDA representatives are keeping their names confidential.
The Right to Life Committee has concerns about the safety of mifepristone, saying that it can induce heavy bleeding or even hemorrhaging in some women, and raises questions about the secret nature of the U.S. distributor.
"What happens when you try to go back and find somebody who's accountable and you've got all kinds of shell companies and you've got a secret manufacturer?" O'Bannon asked.
FDA discounts criticism
The FDA has rejected the argument that providing a cloak of secrecy for Danco and its manufacturer will make it difficult for women who might be harmed by the pill's side effects from seeking a responsible party.
"As it does with all products that it's considering approving, the FDA inspects the manufacturing facility," said an FDA spokesman.
Once the approval was final, Danco and the rest of the abortion-rights community swung into action. The company, which had been so secretive before, suddenly started granting interviews.
The compound will be sold under the name Early Option, with the wholesale name of Mifeprex, said O'Neill, who serves as Danco's spokeswoman.
It will be marketed not by a phalanx of salesmen, as are most pharmaceuticals, but through brochures sent to doctors and through presentations at medical conferences. With its Web site, which was ready to go when regulatory approval came through, Danco plans to reach out directly to women, she said.
Under FDA rules for the drug, it will not be available in pharmacies but rather through mail-order or other forms of direct marketing by Danco.
The pills will be shipped directly to the doctor's office.
A price has not yet been set, but several sources among those who have worked on the project said the cost has been targeted at around $80 per pill.