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“If my practice has a theme,” says Wiley Rein & Fielding partner Bert Rein, “it’s the limits of government authority and the proper boundaries of power.” A key player in some of the highest-profile food-and-drug conflicts in recent years, Rein has a record of successfully fighting off attempts by the government to expand oversight of industry. Notably, Rein, 64, represented Brown & Williamson (now part of R.J. Reynolds Tobacco Co.) in the long struggle against the Food and Drug Administration’s bid to regulate tobacco products. In 2000 the Supreme Court rejected the FDA’s claim of jurisdiction. Rein was also lead counsel for the Washington Legal Foundation in a case addressing the applicability of the First Amendment to FDA regulation of prescription drug advertising. The final decision from the U.S. Court of Appeals for the D.C. Circuit in 2000 established the ground rules for disseminating information about “off-label” uses for prescription drugs — that is, uses not specifically approved by the FDA. Two years later, Rein persuaded the D.C. federal trial court to set aside the FDA’s effort to require drug makers to study their products’ effect on children, even if the product is not explicitly marketed for children’s use. (Congress subsequently established new guidelines for pediatric testing.) Rein’s clients — the Association of American Physicians and Surgeons, the Competitive Enterprise Institute, and Consumer Alert — argued that the pediatric rule exceeded the FDA’s statutory authority and that its promulgation was arbitrary and capricious. “He’s phenomenal,” says Jeffrey Chasnow, senior corporate counsel at Pfizer Inc. “Bert has a unique mastery of FDA issues.” Chasnow praises Rein’s “very astute and very strategic judgment,” as well as his ability to “come up with workable solutions that make sense.” Rein recently represented Pfizer in a case likely to have a major impact on competition between brand-name and generic drugs. In June the D.C. Circuit upheld a lower court decision that Pfizer could sell a generic version of its blockbuster drug Neurontin, which is used to treat epilepsy and to relieve pain. When Teva Pharmaceutical Industries Ltd. secured the rights to market a generic version of Neurontin, Pfizer moved immediately to market its own “authorized generic.” Teva filed suit, asking the FDA to stop Pfizer. Teva argued that the 180-day exclusivity period granted to the first generic marketer should also bar the brand-name maker from offering a generic version. The court said no — a decision that stands to undercut the profitability of generic-drug makers and reduce incentives to challenge drug patents. “It’s a major, major issue for the generic industry,” says Rein, who expects that generic companies will lobby for a legislative fix in upcoming months. On Oct. 5, Rein is scheduled to argue for Wyeth Pharmaceuticals, maker of the anti-nausea drug Phenergan, in a case before the Vermont Supreme Court. The company is appealing a $7.4 million jury verdict in favor of a woman who lost her arm to gangrene after receiving an injection of the drug in an artery. The FDA permits administration of the drug in a vein as a last resort, and the drug label warns of the possibility of gangrene if an artery is hit instead. The question is whether Wyeth nonetheless should have barred intravenous use as too risky. Rein is not exclusively a food-and-drug specialist; his practice also includes antitrust and other litigation work. To some, this is an asset. “He has a breadth of experience, and the ability to remember cases and legal theories and make connections that are not immediately apparent,” says Marjorie Powell, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, which has turned to Rein for strategic advice for more than 10 years. “He can come up with a whole variety of potential options, and he has the ability to evaluate their likelihood of success.” Rein graduated from Harvard Law School in 1964. After a two-year stint in the U.S. Army, he clerked for Supreme Court Justice John Marshall Harlan and then joined the D.C. office of Kirkland & Ellis. He moved to the State Department in 1969, rising to become deputy assistant secretary for economic and business affairs. Highlights of Rein’s government service included negotiating the Intelsat satellite agreement with 70 countries. In 1973, Rein rejoined Kirkland & Ellis, where he remained until 1983, when he and 36 other lawyers broke off to form Wiley Rein & Fielding.

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