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The Generic Pharmaceuticals Association (GPhA) has announced the election of Bruce L. Downey, chairman and chief executive officer (CEO) of Barr Generic Pharmaceutical Inc (Woodcliff Lake, NJ), as chairman of its Board of Directors for 2006- 2007. He succeeds Heather Bresch, senior vice president of strategic corporate development for Mylan Laboratories Inc, after serving as vicechairman last year. Downey has been an active member of GPhA, as well as its prior organizations, for many years and has already served several terms on the board's Executive Committee.
"We are pleased to welcome Mr. Downey as our new chairman," said Kathleen Jaeger, GPhA president and CEO. "He has been an outspoken advocate for the generic industry and a leader in efforts to make generic biopharmaceuticals a reality in the United States. Downey's extensive industry knowledge and experience will help us in our efforts to lead America into a healthy future."
Downey has testified before the House Committee on Energy and Commerce (subcommittee on health) on behalf of GPhA and its member companies. He also has represented Barr and GPhA before both the House and the Senate and often appears before the financial press on CNBC and Bloomberg Media. Prior to becoming involved in the generic pharmaceutical industry, Downey practiced law in the area of civil litigation, where he represented corporate clients on a broad range of issues before federal and state courts and agencies of the federal government.
Downey became a member of the Board of Directors of Barr Pharmaceuticals in January 1993 and was elected chairman of the board and CEO of the company in February 1994. From January 1993 to December 1999, he also served as president of the company. From 1981 to 1993, Downey was a partner in the law firm of Winston & Strawn and a predecessor firm, Bishop, Cook, Purcell & Reynolds. For 3 years prior to joining Barr, Downey served as the company's legal counsel.
Downey foresees continued progress for the generic drug industry and hopes to assist GPhA in accelerating that progress in his capacity as chairman. He said that he is proud to serve alongside the other elected members of GPhA's Executive Board: Heather Bresch, vice chairman; Rosendo Ferran, senior consultant, New Chemic Inc, who will serve as secretary-treasurer; and William Marth, president and CEO, Teva Pharmaceuticals USA, and Michael Collins, group president, Mallinckrodt Inc, who will serve as at-large members.
Downey expressed an expectation that GPhA can continue to accelerate legislative interest in generic biopharmaceuticals. He would like to see the FDA implement in the near future an abbreviated approval pathway for generic biopharmaceuticals that utilizes the existing provisions already provided under the Hatch/Waxman Act.
He also voiced concern over the growth of so-called authorized generics. He hopes to see the FDA honor "true exclusivity"that is, "the first generic to file during the 180-day period should be honored as the authorized generic [for that drug]," he said. GPhA hopes that Congress will reevaluate the FDA's interpretation of allowing authorized generics and, in the intention of the provision laid out in the Hatch/Waxman Act, allow true generics the opportunity to be the only generic product during the exclusivity period, while providing patients with lower-priced drugs.
Downey also sees the consolidation of pharmaceutical companies as a benefit to the industry in general. As struggling companies are aided by their stronger counterparts, both companies become better and produce a higherquality product. He says that "consolidation serves a purpose to make companies better," as they come together to form "a stronger individual company."
Downey said that he is honored to serve as GPhA's chairman. He looks forward to working with Jaeger and his fellow board members to advance the interests of generic pharmaceutical companies and keep them growing stronger for years to come.