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Interview with Kathleen Jaeger, President of GPhA.
The generic pharmaceutical industry enjoyed lavish publicity in June, thanks to the Food & Drug Administration's final rules on generic drug approvals under the Waxman-Hatch amendments and House and Senate legislation equally favorable to generic drugmakers. In an attempt to sort out what it all means for the future of generic drugs and its impact on consumers, Kathleen Jaeger, president of the Generic Pharmaceutical Association (GPhA), spoke with Anthony Vecchione, Managing Editor/Projects for Drug Topics magazine.
DT:What is GPhA's reaction to the FDA rules and the Senate/House legislation?
KJ: We're pleased with the final rule. I think that it clearly complements the legislation that's under consideration right now in the House. The rule really does provide some essentials for patent clarification as well as patent certification enhancements. We applaud Congress for making history with Medicare legislation, and for taking unprecedented action to ensure that all American consumers have timely access to affordable pharmaceuticals.
DT:How drastic will the compromises be?
KJ: We've actually had a bipartisan compromise in the Senate already. We think that the Senate piece is very solid. It will effectuate the intention of closing these loopholes and bringing products to market in a timely fashion. In conference we'll be pushing very hard to ensure that this measure will not be diluted or weakened.
DT: What is your response to the PhRMA position that the recent amendments to Waxman-Hatch aren't necessary and that the current system is working just fine?
KJ: We believe that the FDA rule complements the legislation. It provides two components to a seven-component system. Each piece of the puzzle is really needed to ensure that we get products to the marketplace in a timely manner. With respect to the rule, there is no enforcement mechanism there, and really, where the enforcement mechanisms are, they actually reside in this piece of legislation that we are actively working on right now. And without those enforcement mechanisms, there really isn't any incentive for the brand companies to abide by the rules and not necessarily utilize unintended loopholes in the system to extend their life cycle management.
DT:How do you respond to reports about the prices of generic drugs rising?
K.J: Prices are going to be sensitive to supply and demand. I call this the economics 101 concept. When you look at the average price of a generic pharmaceutical in 2002, it was about $24, according to IMS. The brand counterpart was roughly about $80. Generics are really presenting a tremendous health and economic value to a health system.
DT:What are some other issues that are high on the GPhA agenda right now?
KJ: Our highest priority, of course, is Waxman-Hatch reform. We also have a parallel track for appropriations. We need the additional resources to get these generic products into the marketplace faster. Dr. McClellan [Food & Drug Administration commissioner] has launched a major initiative with respect to the review of all products, including generics, and we are looking forward to working with the FDA on this initiative to reduce approval times for our products. We hope to partner with the FDA with respect to education of consumers on generics and getting the message out about the value of our products.
DT:What are some of the accomplishments that you are most proud of ?
KJ: The trade association has achieved recognition as a solid healthcare player in Washington, D.C., and on Capitol Hill. It's also been a credible source of healthcare information and, as we look to the future, we are going to continue to expand our efforts in the states and international arena.
DT:What are some of your other key plans going forward?
KJ: With respect to other legislative issues, one of the next things that we will undertake aggressively is a generic biopharmaceutical campaign. That remains a high priority for us. We want to bring these products into the market based on sound scientific evidence and in a timely fashion.
DT:How should consumers read the recent FDA and legislative developments?
KJ: We are proud to be an important part of this landmark legislation that will create a prescription drug benefit for seniors. Consumers should be optimisticcautiously optimisticas we go into conference. I think they will truly be the victors if we can emerge from conference with a Senate compromise.
Tony Vecchione. GPhA's Jaeger upbeat about future of generics. Drug Topics Generic Supplement;147:12s.