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Sep 17, 2011
09/11
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dr. martello, as we heard from mr. johnston, the generic companies are working with fda do their fair share and provide the fda with additional resources to increase foreign inspection capacity. while i realize that the brand companies don't occupy as much as the market as the generics do, would your member companies be willing to contribute to securing the supply chain through increased user fees? >> thanks very much for that question. i think it's important to recognize that since 1992 the peduva user frees, prescription drug user fees that we're looking to reauthorize next year have supported preapproval inspections since their inception in 1992, and as the gao has reported the majority of facility inspections that are conducted are both preapproval and gmp's inspections combined so our industry is really committed to this issue and has supported inspections in the form of the user fees as a portion of that since 1992. we also think, and we recognize, that frankly, there is -- there will never be enough resources fo
dr. martello, as we heard from mr. johnston, the generic companies are working with fda do their fair share and provide the fda with additional resources to increase foreign inspection capacity. while i realize that the brand companies don't occupy as much as the market as the generics do, would your member companies be willing to contribute to securing the supply chain through increased user fees? >> thanks very much for that question. i think it's important to recognize that since 1992...
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Sep 14, 2011
09/11
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dr. martello. now we turn to mr. gordon johnston, welcome and please proceed. >> good morning, chairman harkin, ranking member enzi, and members of the committee. thank you for asking me to participate in this timely and important hearing. i am gordon johnston, senior advisor for regulatory sciences at the generic pharmaceutical association, or gphagpha represents the manufacturers and distributors of generic pharmaceuticals and active ingredients. generic pharmaceuticals now fill 78% of all prescriptions dispensed in the united states, but consume just 25% of the nation's total drug expenditure. prior to joining i served the u.s. public health service and in 1987 was assigned to the food and drug administration and became the deputy director of the office of generic drug in 1994. securing the nation's pharmaceutical supply chain is of vital importance to gpha and our member companies. we also have a keen interest in a level and accountable playing field of all participants in the supply chain. we commend the committ
dr. martello. now we turn to mr. gordon johnston, welcome and please proceed. >> good morning, chairman harkin, ranking member enzi, and members of the committee. thank you for asking me to participate in this timely and important hearing. i am gordon johnston, senior advisor for regulatory sciences at the generic pharmaceutical association, or gphagpha represents the manufacturers and distributors of generic pharmaceuticals and active ingredients. generic pharmaceuticals now fill 78% of...
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Sep 15, 2011
09/11
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dr. martello, as we heard from mr. johnston, the generic companies are working with fda do their fair share and provide the fda with additional resources to increase foreign inspection capacity. while i realize that the brand companies don't occupy as much as the market as the generics do, would your member companies be willing to contribute to securing the supply chain through increased user fees? >> thanks very much for that question. i think it's important to recognize that since 1992 the peduva user frees, prescription drug user fees that we're looking to reauthorize next year have supported preapproval inspections since their inception in 1992, and as the gao has reported the majority of facility inspections that are conducted are both preapproval and gmp's inspections combined so our industry is really committed to this issue and has supported inspections in the form of the user fees as a portion of that since 1992. we also think, and we recognize, that frankly, there is -- there will never be enough resources fo
dr. martello, as we heard from mr. johnston, the generic companies are working with fda do their fair share and provide the fda with additional resources to increase foreign inspection capacity. while i realize that the brand companies don't occupy as much as the market as the generics do, would your member companies be willing to contribute to securing the supply chain through increased user fees? >> thanks very much for that question. i think it's important to recognize that since 1992...
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Sep 17, 2011
09/11
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dr. martello. we'll turn to mr. gordon johnson with the generic pharmaceutical association. welcome. please proceed. >> good morning chairman harkin, ranking member enzy and members of the committee. thank you for asking me to participate in this timely and important hearing. i am gordon johnston senior adviser for regulatory sciences. gpha represents the manufacturer's and distributors of generic pharmaceuticals and active ingredients. generic pharmaceuticals now fill 78% of all prescriptions in the united states. i served in the u.s. public health service, and in 1987 was assigned to the fda. securing the nation's pharmaceutical supply chain is of vital importance to gpha and our member companies. we have a key interest in a level, competitive and accountable playing field in the supply chain. we commend the committee for your focus on ensuring the safety of america's pharmaceutical supply, brand and generic. gpha is committed to doing everything possible to promote a vigorous and rigorous oversight of the nation's drug supply. as the committee begins to take a closer look at this
dr. martello. we'll turn to mr. gordon johnson with the generic pharmaceutical association. welcome. please proceed. >> good morning chairman harkin, ranking member enzy and members of the committee. thank you for asking me to participate in this timely and important hearing. i am gordon johnston senior adviser for regulatory sciences. gpha represents the manufacturer's and distributors of generic pharmaceuticals and active ingredients. generic pharmaceuticals now fill 78% of all...