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New drugs don’t win approval simply because the company hires a clever lawyer, says Robert Brady. The Food and Drug Administration focuses on the scientific data — and the agency “gets it right the vast majority of the time.” What a smart attorney can do, says the Hogan & Hartson partner, is help companies “shape their data and approval strategy” for a smooth review by the FDA. With eight years of experience inside the agency, Brady, 58, is well equipped to offer such advice, on everything from biologic medicines to orphan drugs. He also counsels on advertising and promotional practices. “He is extremely knowledgeable about FDA regulations and laws, but more importantly, he understands how the agency actually works,” says Dr. Steven Gould, CEO of Northfield Laboratories Inc. For the past three years, Brady has been advising the company on its development of an oxygen-carrying blood substitute. It’s uncharted territory — the FDA has never approved such a product. “Many companies have tried and failed, but we’ve gotten further than anyone,” Gould says. Northfield is now in a Phase III trial of its product, PolyHeme. “To get to this point we really needed Bob’s input,” Gould says. Last month, Brady helped win FDA approval for another biologic product — a category that includes blood products, vaccines, and products derived from human cells and tissues. Made by Tercica Inc., the drug, Increlex, was approved Aug. 30 after a priority review. It is a variation of human growth hormone and is used to treat children with extremely short stature. Tercica board member Michael Astrue describes Brady as “terrific, a first-class lawyer and person.” As the former general counsel of Biogen Inc., Astrue has worked with Brady for more than 10 years. Biogen tapped Brady as lead regulatory counsel in a 1995-96 battle with the German company Schering AG over the drug Avonex, used to treat multiple sclerosis. “We won everything,” says Astrue, who praises Brady for his mastery of the law and expertise on biologics. Both Avonex (at the time of approval) and Increlex are considered “orphan drugs” — generally that means fewer than 200,000 people in the United States suffer from the disease that the drugs target. Under the Orphan Drug Act, the FDA grants seven years of market exclusivity as an incentive for pharmaceutical companies to develop such drugs. Brady estimates that about half of his practice involves “counseling companies on various approval pathways.” He also advises companies on advertising and promotional matters as well as crisis management issues. For about seven years the Genzyme Corp. has turned to Brady for such assistance, says chief compliance officer Roger Louis. According to Louis, Brady excels at “taking complex rules and making them simple and actionable for clients.” But Brady is more than a good lawyer. “He’s a really good nonlawyer as well,” Louis says. That is, he’s approachable, he speaks the language of businesspeople, and he “takes the time to listen and make sure he knows what the problem or issue is before he starts dispensing advice.” Brady earned his J.D. from the George Washington University in 1972. He clerked first for Judge Gerald Powers of the Maryland Court of Special Appeals and then for Judge James Wray of the Maryland Circuit Court for Ann Arundel County. Brady joined the FDA chief counsel’s office in 1975. Over the next several years he served as associate chief counsel for biologics, foods, and enforcement. From 1981 to 1983, Brady was executive assistant to acting FDA Commissioner Mark Novitch and then to FDA Commissioner Arthur Hull Hayes. The biggest issue at the time, he recalls, was the poisoning of Tylenol capsules with cyanide. “It was a real crisis. People were afraid to use their medicines,” he says. Brady signed on as general counsel of the Cosmetic, Toiletry and Fragrance Association in 1984. Later, he became the association’s executive vice president, and he continues to advise companies in the cosmetics field today. In 1988, Brady joined then-Patton, Boggs & Blow as a partner; he moved to Hogan & Hartson in 1995. He now heads Hogan’s 15-lawyer pharmaceutical/ biotechnology practice. Notable colleagues include David Fox, Jonathan Kahan, Edward Korwek, and Richard Silverman.

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