The Generic PharmaceuticalsAssociation (GPhA) has announcedthe election of Bruce L.Downey, chairman and chief executiveofficer (CEO) of Barr Generic PharmaceuticalInc (Woodcliff Lake, NJ), as chairmanof its Board of Directors for 2006-2007. He succeeds Heather Bresch,senior vice president of strategic corporatedevelopment for MylanLaboratories Inc, after serving as vicechairmanlast year. Downey has beenan active member of GPhA, as well asits prior organizations, for many yearsand has already served several termson the board's Executive Committee.
"We are pleased to welcome Mr.Downey as our new chairman," saidKathleen Jaeger, GPhA president andCEO. "He has been an outspoken advocatefor the generic industry and aleader in efforts to make generic biopharmaceuticalsa reality in the UnitedStates. Downey's extensive industryknowledge and experience will help usin our efforts to lead America into ahealthy future."
Downey has testified before theHouse Committee on Energy and Commerce(subcommittee on health) onbehalf of GPhA and its member companies.He also has represented Barr andGPhA before both the House and theSenate and often appears before thefinancial press on CNBC and BloombergMedia. Prior to becoming involved inthe generic pharmaceutical industry,Downey practiced law in the area ofcivil litigation, where he representedcorporate clients on a broad range ofissues before federal and state courtsand agencies of the federal government.
Downey became a member of theBoard of Directors of Barr Pharmaceuticalsin January 1993 and was electedchairman of the board and CEO ofthe company in February 1994. FromJanuary 1993 to December 1999, he alsoserved as president of the company.From 1981 to 1993, Downey was a partnerin the law firm of Winston & Strawnand a predecessor firm, Bishop, Cook,Purcell & Reynolds. For 3 years prior tojoining Barr, Downey served as the company'slegal counsel.
Downey foresees continued progressfor the generic drug industry and hopesto assist GPhA in accelerating thatprogress in his capacity as chairman. Hesaid that he is proud to serve alongsidethe other elected members of GPhA'sExecutive Board: Heather Bresch, vicechairman; Rosendo Ferran, senior consultant,New Chemic Inc, who willserve as secretary-treasurer; andWilliam Marth, president and CEO, TevaPharmaceuticals USA, and MichaelCollins, group president, Mallinckrodt Inc,who will serve as at-large members.
Downey expressed an expectationthat GPhA can continue to acceleratelegislative interest in generic biopharmaceuticals.He would like to see theFDA implement in the near future anabbreviated approval pathway forgeneric biopharmaceuticals that utilizesthe existing provisions already providedunder the Hatch/Waxman Act.
He also voiced concern over thegrowth of so-called authorized generics.He hopes to see the FDA honor "trueexclusivity"—that is, "the first generic tofile during the 180-day period should behonored as the authorized generic [forthat drug]," he said. GPhA hopes thatCongress will reevaluate the FDA'sinterpretation of allowing authorizedgenerics and, in the intention of the provisionlaid out in the Hatch/WaxmanAct, allow true generics the opportunityto be the only generic product duringthe exclusivity period, while providingpatients with lower-priced drugs.
Downey also sees the consolidationof pharmaceutical companies as a benefitto the industry in general. As strugglingcompanies are aided by theirstronger counterparts, both companiesbecome better and produce a higherqualityproduct. He says that "consolidationserves a purpose to make companiesbetter," as they come together toform "a stronger individual company."
Downey said that he is honored toserve as GPhA's chairman. He looks forwardto working with Jaeger and his fellowboard members to advance theinterests of generic pharmaceuticalcompanies and keep them growingstronger for years to come.