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When it comes to big problems — the really big problems — William Vodra is often the lawyer of choice. Whether advising Pfizer Inc. on how to deal with the Bjork-Shiley heart valve defect or representing the American Red Cross over blood safety problems, the Arnold & Porter partner has a long record of managing crises. “If the chips are really on the line and it’s a situation where you’ve got to have the best . . . he’s the person I call,” says Steve Oldham, general counsel for the Roche Diagnostics Corp. Vodra, 62, is now helping Roche respond to a warning letter from the Food and Drug Administration about kits used to test for sexually transmitted diseases. Oldham describes Vodra as “someone who can really give you the big picture of what you’re facing and practical advice for how to get to the other side.” He also praises Vodra’s ability to “relate his experience to your particular situation in a way management finds easy to accept. That makes my job a lot easier.” Lawrence Stein, general counsel at Wyeth Corp., points to Vodra’s “encyclopedic knowledge of food and drug law.” But, Stein adds, “he’s not simply a narrow specialist. He has the ability to bring his experience and judgment to bear in contexts that are broader than a particular regulatory problem.” Vodra is assisting Wyeth with regulatory issues and product liability litigation. Pfizer is a longtime client. One of Vodra’s early matters for the company involved the arthritis drug Feldene. In 1986, Public Citizen’s Sidney Wolfe petitioned the FDA to ban Feldene as an “imminent hazard.” Instead, says Vodra, the FDA issued “a total and complete bill of good health” for Feldene as compared with other arthritis drugs. A few years later, Pfizer faced a more dire problem. Reports came out that the Bjork-Shiley heart valve, which had been implanted in more than 70,000 people, could break down. The result was usually fatal. The company’s stock had dropped 15 percent, Public Citizen was calling for FDA action, litigation was pending, and a congressional hearing loomed ahead. So Pfizer turned to Vodra. The 1989 hearing, Vodra recalls, “was a critical event.” Also important was Pfizer’s subsequent announcement that it would track down and directly notify patients who had received the valve. Vodra assisted in that effort, as well. It was a delicate task, to say the least. “How do you tell people there’s a problem with something implanted in their body?” says Vodra. And while it was likely the recipients would die if the valve broke, he asserts, “it was even more risky to have open-heart surgery to remove it.” The American Red Cross also faced a high-profile problem. The organization was under fire for dangerous blood handling practices at its regional blood banks. Vodra represented the Red Cross in negotiating a 1993 consent decree requiring better management of blood service operations and improved quality controls. These days, Vodra also helps drug companies deal with the threat of criminal charges. As the pharmaceutical industry has come under increased scrutiny in recent years, he says, “the risk is substantial that any serious regulatory problem could evolve into a criminal investigation.” Vodra earned his law degree in 1968 from Columbia University School of Law and then joined the Cincinnati firm Taft, Stettinius & Hollister. In 1971 he came to Washington to work in the Justice Department’s Bureau of Narcotics & Dangerous Drugs (renamed the Drug Enforcement Administration in 1973). Vodra dealt with licensing, security, and record-keeping issues for legal narcotics. “It was the most sheer fun I’ve ever had in a job,” he recalls. Vodra moved to the FDA in 1974 and was promoted to associate chief counsel for drugs in 1975. He helped write regulations for good laboratory, manufacturing, and clinical practices, along with working on the development of the Orange Book, which lays out therapeutic equivalents between brand-name and generic drugs. And he successfully defended the agency’s decision to ban the diabetes drug phenformin. In 1979, Vodra left the government to join Arnold & Porter’s Washington office. He made partner in 1983. Notable colleagues at the firm include Arthur Levine, who is known for his expertise in responding to the threat of FDA enforcement actions, and Donald Beers, who handles a wide variety of FDA issues.

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