The Generic Pharmaceutical Association recently held its annual meeting in Boca Raton, Fla. The event featured an impressive lineup of speakers from FDA (Lester Crawford among them) and industry. Outlines of many of those presentations may be accessed by clicking here.The meeting also provided a high-profile forum for the group to continue its campaign for greater public recognition, a more accommodating regulatory environment, and for legislation to pave the way for generic biopharmaceuticals. In addition, the event was an opportunity to further GPhAs assault on brand-name pharmaceuticals. The meetings opening remarks by Kathleen Jaeger, GPhAs president and CEO, follow. Opening Remarks of Kathleen Jaeger
GPhA President and CEO
Generic Pharmaceutical Association Annual Meeting
February 25, 2005Good morning and welcome to the GPhA 2005 annual meeting. We have an exceptional meeting planned . . . and we are delighted to offer you an agenda filled with leaders from the administration, FDA, CMS, and business. We are confident you will leave this meeting with a much better understanding of the challenges and opportunities we face in 2005 and beyond. . .As we have just seen, 2004 was a foundation year for our association, a year in which we broadened our infrastructure, enhanced our relationship with coalition groups, and made our presence known on the state, national and international level. We clearly communicated our position on the key strategic areas that will be the focus of our activities in 2005. I would like to take a few minutes this morning to frame those issues and to outline our objectives.During 2003, with the passage of MMA [the Medicare Modernization Act] we closed many of the loopholes in Hatch/Waxman that have prevented the more timely approval and introduction of generic medicines. However, during 2004, we saw the brand industry find new ways to subvert the level playing field envisioned under Hatch/Waxman. The most significant of these tactics are new patent extensions under the guise of biodefense and brand products masquerading as generics. Let me be clear GphA supports the concept of incentives that enhance our nations security during the war on terror and, indeed, we explicitly support a wide range of incentives. But, as Senator Leahy of Vermont said about one of the proposals to extend the bioshield it strikes me as giving everything but the kitchen sink away to the brand industry. Perhaps the most outrageous provision is wild card exclusivity, a supposed incentive for research into counter-bioterrorism drugs. But wild card exclusivity would allow the brand industry to reach into the medicine cabinet of every American and unfairly extend exclusivity on the drug of their choice. Likewise, another harmful concept is to extend patents for already approved drugs. This does little in the way of enhancing our security. Rather, these initiatives will be an egregious burden on consumers and on our healthcare system, especially Medicare and Medicaid. At this critical time, the brand industry should be concentrating on the research and development that will lead to new vaccines and novel antibiotics, products that create a new pharmacological class or fill a medical or security void. Instead, brand pharma wants to profiteer off Americas fears of bioterrorism. It is time for brand pharma to be held accountable, and we at GPhA will do just that. And we wont be alone. We are, and we will continue to ally ourselves, with business, health plans and government purchasers to say no to unnecessary and excessive patent incentives and market exclusivities. We will, as we did last year in testimony on the Hill, support incentives for true research on priorities like novel vaccines, diagnostic agents, and environmental detection systems. We will urge additional incentives such as product liability protections, expanded tax incentives, fast-track FDA review, and additional funding for biotech companies. We can better prepare America without jeopardizing this countrys healthcare system and without asking consumers to pay for brand pharmas greed. And we are not alone in our position. Even one of the experts invited by the supporters of Bioshield II stated that novel products should be the focal point of incentives. Indeed, he specifically stated, I dont want someone figuring out how to make a huge amount of money without really making a contribution. With respect to authorized generics, our position is clear. GPhA will vigorously oppose this blatant effort to undermine the incentive to bring patent challenges under Hatch/Waxman. As we all know, authorized generics devalue the 180-day exclusivity provision. In the long term, this practice, which allows brand pharmaceutical companies to launch their own product either directly or through partners, undermines generic exclusivity and will result in generic companies undertaking fewer patent challenges. And it will result in higher drug prices for consumers, something that is directly contrary to the mission of our industry and the intent of the 1984 law. Another major priority something I like to think of as the new frontier for everyone in this room, and for all Americans is generic biopharmaceuticals. Just last week, GPhA made our voice heard at the DIA and FDA scientific workshop. I will repeat what we said in our summary testimony. The question is not if generic biopharmaceuticals will become a reality. Rather, it is a dual question of how and when. GPhA believes the time is now to establish a pathway. The current science supports it. And health care providers are demanding it. America needs a definitive, flexible, abbreviated approval pathway. The good news is that the science of biopharmaceuticals is now producing exciting new medicines, ones that provide enormous benefit to millions of patients each year. The bad news is that Americas health care system will be burdened with these costs indefinitely unless something is done. Fortunately, Congress, with the assistance of FDA, can help secure Americas future by immediately establishing a definitive, abbreviated approval process for affordable biopharmaceuticals. There is no reason to delay consumer access to generic biopharmaceuticals when sound science supports their approval. We urge FDA to issue guidance documents to provide further advice to industry participants⦠And we urge Congress to give FDA the authority to make the scientific decisions, so that there will be no gaming of the approval process by special interests. And we urge Congress to allow FDA to do what it does best: evaluate science and approve drugs.Beyond these two priorities, GPhA will continue to work on other key issues including importation and product liability. And we will continue to promote the message that is key to our industry Americas generic drugs are safe. And Americas generics provide the same medicine and will yield the same results. Increasing the timely availability of and promoting the increased use of generic pharmaceuticals can save money for consumers and healthcare providers. Generics are part of the solution. I am proud of the progress we made during the year in our national consumer education campaign, and look forward to the anticipated rollout later this spring. Certainly, we will not succeed without a strong team representing your interests. That is why I am pleased with the progress we have made in adding additional, talented, and committed members to our staff. I am also proud that we continue to enhance our ability to communicate with you, our members, and continue to increasing your role in our activities. We will remain focused on enhancing the value of your GPhA membership. In summary, we strengthened our foundation during 2004 and we have set an aggressive agenda for 2005. We believe that we can succeed because of your commitment, the efforts of our talented team, and a singular focus on our mission of improving lives for less. Thank you.
GPhA President and CEO
Generic Pharmaceutical Association Annual Meeting
February 25, 2005Good morning and welcome to the GPhA 2005 annual meeting. We have an exceptional meeting planned . . . and we are delighted to offer you an agenda filled with leaders from the administration, FDA, CMS, and business. We are confident you will leave this meeting with a much better understanding of the challenges and opportunities we face in 2005 and beyond. . .As we have just seen, 2004 was a foundation year for our association, a year in which we broadened our infrastructure, enhanced our relationship with coalition groups, and made our presence known on the state, national and international level. We clearly communicated our position on the key strategic areas that will be the focus of our activities in 2005. I would like to take a few minutes this morning to frame those issues and to outline our objectives.During 2003, with the passage of MMA [the Medicare Modernization Act] we closed many of the loopholes in Hatch/Waxman that have prevented the more timely approval and introduction of generic medicines. However, during 2004, we saw the brand industry find new ways to subvert the level playing field envisioned under Hatch/Waxman. The most significant of these tactics are new patent extensions under the guise of biodefense and brand products masquerading as generics. Let me be clear GphA supports the concept of incentives that enhance our nations security during the war on terror and, indeed, we explicitly support a wide range of incentives. But, as Senator Leahy of Vermont said about one of the proposals to extend the bioshield it strikes me as giving everything but the kitchen sink away to the brand industry. Perhaps the most outrageous provision is wild card exclusivity, a supposed incentive for research into counter-bioterrorism drugs. But wild card exclusivity would allow the brand industry to reach into the medicine cabinet of every American and unfairly extend exclusivity on the drug of their choice. Likewise, another harmful concept is to extend patents for already approved drugs. This does little in the way of enhancing our security. Rather, these initiatives will be an egregious burden on consumers and on our healthcare system, especially Medicare and Medicaid. At this critical time, the brand industry should be concentrating on the research and development that will lead to new vaccines and novel antibiotics, products that create a new pharmacological class or fill a medical or security void. Instead, brand pharma wants to profiteer off Americas fears of bioterrorism. It is time for brand pharma to be held accountable, and we at GPhA will do just that. And we wont be alone. We are, and we will continue to ally ourselves, with business, health plans and government purchasers to say no to unnecessary and excessive patent incentives and market exclusivities. We will, as we did last year in testimony on the Hill, support incentives for true research on priorities like novel vaccines, diagnostic agents, and environmental detection systems. We will urge additional incentives such as product liability protections, expanded tax incentives, fast-track FDA review, and additional funding for biotech companies. We can better prepare America without jeopardizing this countrys healthcare system and without asking consumers to pay for brand pharmas greed. And we are not alone in our position. Even one of the experts invited by the supporters of Bioshield II stated that novel products should be the focal point of incentives. Indeed, he specifically stated, I dont want someone figuring out how to make a huge amount of money without really making a contribution. With respect to authorized generics, our position is clear. GPhA will vigorously oppose this blatant effort to undermine the incentive to bring patent challenges under Hatch/Waxman. As we all know, authorized generics devalue the 180-day exclusivity provision. In the long term, this practice, which allows brand pharmaceutical companies to launch their own product either directly or through partners, undermines generic exclusivity and will result in generic companies undertaking fewer patent challenges. And it will result in higher drug prices for consumers, something that is directly contrary to the mission of our industry and the intent of the 1984 law. Another major priority something I like to think of as the new frontier for everyone in this room, and for all Americans is generic biopharmaceuticals. Just last week, GPhA made our voice heard at the DIA and FDA scientific workshop. I will repeat what we said in our summary testimony. The question is not if generic biopharmaceuticals will become a reality. Rather, it is a dual question of how and when. GPhA believes the time is now to establish a pathway. The current science supports it. And health care providers are demanding it. America needs a definitive, flexible, abbreviated approval pathway. The good news is that the science of biopharmaceuticals is now producing exciting new medicines, ones that provide enormous benefit to millions of patients each year. The bad news is that Americas health care system will be burdened with these costs indefinitely unless something is done. Fortunately, Congress, with the assistance of FDA, can help secure Americas future by immediately establishing a definitive, abbreviated approval process for affordable biopharmaceuticals. There is no reason to delay consumer access to generic biopharmaceuticals when sound science supports their approval. We urge FDA to issue guidance documents to provide further advice to industry participants⦠And we urge Congress to give FDA the authority to make the scientific decisions, so that there will be no gaming of the approval process by special interests. And we urge Congress to allow FDA to do what it does best: evaluate science and approve drugs.Beyond these two priorities, GPhA will continue to work on other key issues including importation and product liability. And we will continue to promote the message that is key to our industry Americas generic drugs are safe. And Americas generics provide the same medicine and will yield the same results. Increasing the timely availability of and promoting the increased use of generic pharmaceuticals can save money for consumers and healthcare providers. Generics are part of the solution. I am proud of the progress we made during the year in our national consumer education campaign, and look forward to the anticipated rollout later this spring. Certainly, we will not succeed without a strong team representing your interests. That is why I am pleased with the progress we have made in adding additional, talented, and committed members to our staff. I am also proud that we continue to enhance our ability to communicate with you, our members, and continue to increasing your role in our activities. We will remain focused on enhancing the value of your GPhA membership. In summary, we strengthened our foundation during 2004 and we have set an aggressive agenda for 2005. We believe that we can succeed because of your commitment, the efforts of our talented team, and a singular focus on our mission of improving lives for less. Thank you.
