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“Everything one could ask for in a lawyer” — that’s how one of Nancy Buc’s clients sums up the 61-year-old founding partner of Buc & Beardsley and former chief counsel of the Food and Drug Administration. “She’s extremely smart and incisive, and capable of thinking through what can and cannot be done — and what should and should not be done,” continues Sandra Arnold, vice president of corporate affairs for the Population Council. Buc worked with the international nonprofit organization in winning FDA approval in 2000 of mifepristone (known in Europe as RU-486), which induces abortion early in pregnancy. More recently, Buc helped the Population Council intervene in a Judicial Watch lawsuit filed under the Freedom of Information Act seeking certain FDA records pertaining to mifepristone. The FDA successfully argued that it has released all responsive records. The case is now before the U.S. Court of Appeals for the D.C. Circuit. Much of her practice, Buc says, entails “working with clients to try to help them get their products approved and negotiate terms.” She describes the work as “very client-specific and fact-specific.” Clive Meanwell, chairman and CEO of the Medicines Co., says he first turned to Buc when his company was having a difficult time getting the FDA green light for Angiomax, a blood thinner used in patients undergoing coronary angioplasty procedures. Buc played a “huge role” in securing FDA approval in December 2000, says Meanwell. “But the real trick,” he adds, “is to get Nancy involved in planning, not just salvaging.” Buc now regularly advises the company on strategy and compliance issues. “She’s sharp as a tack,” Meanwell says. “She has a profound understanding of the law — not only the content, but the principles.” Buc also helps brand-name drug makers fight off generic challenges. In 1997, she represented Wyeth-Ayerst Laboratories, the maker of Premarin, a hormone replacement product and, at the time, one of the most-prescribed drugs in the United States. Barr Laboratories Inc. and Duramed Pharmaceuticals Inc. (the companies have since merged) both sought FDA approval to market a generic version of Premarin, which Buc describes as “a very complex little drug.” The question was whether the would-be generics were truly equivalent, since they did not contain all the estrogens found in the brand-name version. Ultimately, the FDA refused to approve the generic versions. Buc earned her law degree from the University of Virginia in 1969, one of just seven women in a class of 250. Her first job as a lawyer was with the Federal Trade Commission, mainly, she says, because it was one of the few places interested in hiring women in 1969. She quickly rose to become assistant director of the Bureau of Consumer Protection — the first woman and, at the time, the youngest person ever to serve as assistant director of an FTC bureau. In 1972, Buc joined Weil, Gotshal & Manges in New York. She made partner in 1977 — the first woman partner at the firm — and then returned to Washington to open Weil, Gotshal’s D.C. office in 1978. She was lured back into government in 1980 by an old friend from the FTC, Jodie Bernstein, who had become general counsel of the Department of Health and Human Services. Bernstein recruited Buc for the post of FDA chief counsel, a job Buc held from February 1980 until January 1981. One of the biggest issues on her watch was the outbreak of toxic shock syndrome. Buc negotiated the consent decree with the Procter & Gamble Co. to remove a brand of tampons associated with the illness from the market. She also set the stage for the approval of alpha fetoprotein diagnostic kits, used to assess the likelihood of birth defects in fetuses. And she finalized the rule requiring drug companies to provide information directly to patients about prescription drugs. Buc returned to Weil, Gotshal in 1981. But as she neared her 50th birthday, she says, “I was getting restless,” so she and colleague Kate Beardsley decided to strike out on their own in 1994. Their D.C. firm has grown to eight lawyers. “Kate and I have built a great practice giving personal attention and practical advice to clients who need assertive advocacy at FDA and in the courts,” says Buc. “We’ve had fun doing it, and we’re still having fun.”

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