The French abortion pill's introduction into the United States has been delayed because its American sponsor, the Population Council, is seeking to oust an associate who controls the distribution and marketing of the product.

The nonprofit Population Council holds the U.S. patent to the drug called mifepristone, also known as RU-486. The council's business associate, Joseph D. Pike, is a disbarred lawyer who pleaded guilty to a misdemeanor forgery charge in an unrelated North Carolina case last May.

Council officials say they did not know about Pike's disbarment when they gave him the license to market mifepristone and are concerned that the political fallout from Pike's background could compromise the marketing of the drug.

"Pike's fraud now imperils the mifepristone project," the council said in the suit it has filed seeking Pike's removal from controlling the marketing of the drug. "Unless {he} is expeditiously removed, it will be much more difficult, and perhaps impossible, to raise the additional funds that are still needed to fund the project, and another weapon with which to attack {the abortion pill} will be furnished to its ideological opponents."

Pike says in his response to the lawsuit that he has fulfilled his responsibilities under the contract and that, in any event, his status as an attorney is not relevant to his ability to manage the mifepristone project.

Meanwhile, according to Leslie Sebastian, his spokeswoman, he has separated himself from the daily operations of the project. The Population Council says this is not enough, however, because his separation is voluntary and he could reassume control at any time.

Neither Pike nor his attorney would be interviewed for this article.

At a court hearing Wednesday in New York, U.S. District Judge Sonia Sotomayor rejected Pike's motion to dismiss the council's suit and set trial for March 31 on the issue of whether Pike had defrauded the council by not disclosing his disbarment. If fraud is found, Sotomayor said, she will deal later with the council's request to remove Pike from the project.

Council officials once predicted that mifepristone would be available to American women in mid-1997. It now appears that the pill won't reach the market until the end of the year at the earliest. "We still hope to have this on the market by the end of 1997," said council spokeswoman Sandra Waldman. But legal and financial obstacles will have to be overcome to meet that target, which now seems unlikely to many health specialists. The dispute has already stalled efforts to find investors for the estimated $27.5 million needed to bring the drug to market here.

"This is a mess and it's a terrible shame and it's a big disappointment to a lot of people," said Carolyn Westhoff, associate professor of clinical obstetrics and gynecology at Columbia University. The abortion drug "is a good option for women and it appears this {legal wrangling} is going to delay it," added Westhoff, who helped run safety tests of the drug in this country.

Mifepristone's use in the United States was conditionally approved by the Food and Drug Administration last September pending submission by the council of more information about how the drug will be labeled and manufactured.

The council, based in New York, is a 44-year-old research and development organization that promotes family planning. It became involved in the U.S. manufacture and distribution because no major drug company was willing to take on the politically sensitive pill.

Antiabortion groups have actively opposed the drug's introduction in the United States.

"We oppose RU-486 because it takes the life of an unborn child whose heart has already begun to beat in most cases," said Laura Echevarria, a spokeswoman for the anti-abortion National Right to Life Committee. She said the committee is also against the drug "because it potentially could endanger a woman's health or life."

The committee declined to comment on the council-Pike litigation.

Council officials say concerns about the sometimes violent nature of abortion politics were a factor in persuading them to accept unusually complex arrangements for the drug's marketing that are part of their business relationship with Pike. For example, the identity of the company selected to manufacture the drug for U.S. distribution is being kept secret. Further, the companies set up by Pike to distribute and market the drug were not initially identified.

The abortion drug has been available in France since 1988. Extending its availability to U.S. women was a top priority for the Clinton administration soon after its election.

After heavy lobbying by U.S. officials, the French pharmaceutical firm Roussel Uclaf, a subsidiary of Germany's Hoechst AG, donated its U.S. patent for mifepristone to the council in May 1994. The council was to run clinical trials, obtain FDA approval, find a manufacturer and arrange for the drug's marketing and distribution by the private sector.

The trials began late in 1994 and ended in September 1995; the council filed for FDA approval last March. So far, the council said, it has spent $12 million on the effort. The money came from private donations, loans and council funds.

At the same time, the council sought outside firms to manufacture, package, distribute and market the pill. Whoever got the marketing license would also be expected to find investors to finance the project, which included the clinical trials. The licensee would enjoy the profit from the sale of the drug and would pay the council fees or royalties.

Although the drug is projected to have $100 million in U.S sales annually, several major U.S. pharmaceutical firms were approached by the council and none was "rushing in to do this," council president Margaret Catley-Carlson said in a recent interview.

As a result, council officials sought proposals from others and received five responses, including one from Pike.

Pike has a financial interest in FEI Products Inc., a Buffalo area firm that has manufactured the Copper-T intrauterine device under license to the council, which developed it, since 1988. The council has known Pike since then because of this relationship and, according to Catley-Carlson, has been satisfied with FEI's work on Copper-T.

That business relationship was "a deciding factor" in choosing Pike for the mifepristone project, Catley-Carlson said.

His proposal was also attractive, she said, because it suggested setting up a nonprofit group called Advances in Health Technology Inc. Advances would be separate from the council and handle highly visible educational programs and deal with what Catley-Carlson called the "public defense" of mifepristone.

In December 1995, Advances was licensed by the council to market mifepristone. Advances, with headquarters in Dupont Circle, is headed by physician Susan Allen.

Then Advances, as prearranged by all the parties, immediately sublicensed marketing rights to Pike. Advances was publicly identified as the licensee for mifepristone; Pike was not.

Meanwhile, in California, Pike set up a network of four interlocking, for-profit companies to do the marketing. According to the December 1995 contract, one of Pike's companies would get raw mifepristone from a manufacturer already chosen by the council and never publicly identified. Pike's company would package and distribute the pills.

Another of his companies would test and market mifepristone for potential uses other than early abortion.

Pike's companies were to pay royalties and licensing fees to both the council and Advances and keep the profits. There has been no estimate of what the profits would be.

"The highly complex and secretive arrangements that were established within {Pike's companies} made sense because of the hyper-concern for confidentiality that existed," said Catley-Carlson. "And we accepted them as a response to this very real concern people have about being identified or named."

Last March, a few days after the council applied to the FDA for approval of mifepristone, an investor in the project called Catley-Carlson to ask what she knew about the legal problems of a man named Joseph D. Pike involving a North Carolina real estate deal.

Catley-Carlson said she quickly had her staff call Pike. "Gosh, we've just heard this story. What's up?" she recalled an aide saying. "He said, I don't know. I'll look into it right away.' . . . And then he phoned back here the next morning. And he said it was a different Joseph D. Pike altogether. . . . Nothing to do with him. So you know, we said whew.' "

Sebastian confirmed the substance of that conversation and said that Pike at first denied being the Pike in question to save his family embarrassment. She added that Pike called the council 24 hours later to say he had been disbarred in 1993 in North Carolina.

A few weeks later Catley-Carlson learned that Pike had pleaded guilty to a misdemeanor forgery charge in Raleigh, N.C., in May 1996, received a suspended two-year sentence, was put on probation for 18 months and fined $300. Both the disbarment and conviction stemmed from a 1985 real estate deal in which Pike falsely inflated the cost of the property to two investors, bar records show.

Hoping to avoid delays and embarrassing publicity, in July the council started quietly pressuring Pike to disengage from the venture. Publicly, mifepristone seemed on track with an FDA advisory opinion July 19 that supported its use in the United States.

Meanwhile, Pike had fallen behind in making licensing payments to the council because he "had not yet raised sufficient capital," according to Pike's affidavit filed with the court.

A document Pike filed in court says he eventually raised $13.3 million from private investors and in July he sent $8 million to the council for licensing fees and $540,000 in royalties to Advances. Pike received $300,000 in management fees. The rest of the money went for expenses, the document says.

Council officials say they used the $8 million to repay loans and expenses connected with the mifepristone project.

The council filed suit on Nov. 4, alleging that Pike's "fraudulent concealment" of his past made it impossible for the council to trust him. It alleged that he has not adequately accounted for the money he raised, refused to do an audit, and allocated some funds to "a previously unknown entity" whose name he changed four times in 18 months.

The council keeps "saying he's a terrible person," Sebastian said. "They start screaming about the money. {But} it's our money."

The council has asked the court to order Pike's financial interest in the project transferred to a court-appointed receiver. Waldman said its suit against Pike was filed only after he failed to follow through on his stated intention to leave the project. "It's like the Wizard of Oz," said Waldman. "He's in the back room controling everything and what we ask is that he sell his financial and management control. And that he hasn't done."

Pike, 47, through Sebastian, blames the council for delays in the project, saying it has refused to cooperate with him. He has said he intends to bow out of the project, but only when he finds an appropriate buyer.

"He is not willing . . . to put this project in jeopardy by making a quick, unthoughtful move that would essentially not be the best move for the company," said Sebastian.

"The bottom line is we have this license. We will make sure this drug gets to the market. . . . We have enough problems with {anti-abortion} fanatics. We should not have to worry about the Population Council," Sebastian said.

The controversy has embarrassed the council and generated criticism about its business acumen, especially for failing to check out Pike's background before giving him the market rights to mifepristone. Former council vice president C. Wayne Bardin, referring to the basic principles of contract law that make it difficult to break an agreement, said that "when you go into a business deal, you check everyone out. You check your brother out."

Catley-Carlson doesn't disagree. "When you're in a business relationship with somebody over a period of years it is not habitual to do due diligence on that person," she said. "I now think I would do due diligence on my great aunt." CAPTION: Food and Drug Administration committee member Mary Pendergast and Commissioner David Kessler at a hearing on RU-486 last July. The FDA granted conditional approval of the abortion pill in September.