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Patton Boggs partner Daniel Kracov is known for his keen political instinct and deft touch in handling sensitive matters. Both on Capitol Hill and before food-and-drug regulators, Kracov, 42, makes the best case for the manufacturers of biomedical products, pharmaceuticals, and medical devices. Pfizer Inc., a major client, turns to Kracov for assistance with issues such as drug safety and the Prescription Drug User Fee Act, which comes up for congressional renewal every five years. In an e-mail, Dolly Judge, senior director of federal relations for Pfizer, writes that Kracov is “invaluable as a consultant,” and praises his “ability to leverage his grasp of complicated subject matter along with his political insights.” He uses “his knowledge of the law” and “his understanding of the political environment,” Judge writes, “to expertly guide our strategic thinking.” Kracov’s skills in the legislative arena were on clear display in his representation of Internet contact-lens retailer 1-800-Contacts. The company, he says, was being “thwarted” by the prescription system. To prevent their patients from ordering contact lenses from lower-cost suppliers, Kracov explains, optometrists were simply refusing to give patients copies of their prescriptions. Hired as a lobbyist, Kracov helped bring about the passage of the Fairness to Contact Lens Consumers Act, which went into effect in 2004. The law requires that patients be given copies of their prescriptions. Kracov also helped secure a legislative solution for chemical and biotechnology company Lonza Inc. with the passage of the Food Quality Protection Act of 1996. The matter was critical, says Joseph Robinson, Lonza’s vice president of regulatory affairs, because an earlier law had changed the classification of some of the company’s products, thereby transferring regulatory oversight from the Food and Drug Administration to the Environmental Protection Agency. The act returned jurisdiction to the FDA. Lonza has turned to Kracov for assistance with a variety of regulatory matters for more than 10 years, Robinson says. He describes Kracov as “aggressive, but not in a negative sense,” and praises his direct manner: “He won’t just say what the client wants to hear. It’s an open and honest discussion.” Kracov is currently advising Pain Therapeutics Inc. on FDA-related strategy as it seeks to win approval for a series of new products. Pain Therapeutics is using a controlled-release mechanism to create abuse-resistant forms of controlled substances such as OxyContin. The company “is trying to use technology to make drugs safer,” says Kracov. “There’s a lot of interest in these products.” Hence, he continues, they “should be accelerated to market.” Kracov is also counseling Bavarian Nordic A/S on its efforts to provide smallpox vaccines for the U.S. stockpile. Hoffmann-LaRoche Inc. is a big client. Kracov advises the company on regulatory and policy matters, including issues related to an anti-viral medication used to treat avian flu. He also helped Roche manage congressional inquiries in 2002 into its acne drug Accutane amid allegations of associated suicide risk among adolescents. In another highly sensitive case, Kracov represented Johns Hopkins University School of Medicine scientist Alkis Togias. A participant in Togias’ medical study on asthma died in 2001 after inhaling an experimental chemical. The episode received widespread publicity and raised questions about whether more federal safeguards are needed to protect research subjects. “It was a real lesson in what can go wrong,” observes Kracov. Johns Hopkins settled the case for an undisclosed sum, and federal regulators temporarily suspended all human experimentation at the school. Kracov received his law degree from the University of Virginia in 1988. He had worked at Patton Boggs as a summer associate and joined the firm upon graduation. A partner since 1995, he is currently deputy director of Patton Boggs’ public policy and regulatory department. Notable colleagues include Stuart Pape and Paul Rubin. Food-and-drug work offers a “fascinating combination of law, policy, science, health care,” says Kracov. “It hits a lot of different buttons in terms of my personal interests.”

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