议院通过儿科专一性恢复议案
WASHINGTON (Reuters Health) - Over the objections of Democrats, the House Thursday passed legislation that would renew a 1997 law providing six additional months of market exclusivity to drugmakers who test their products on children at the request of the US Food and Drug Administration (FDA).
The House by a vote of 338-86 approved the Best Pharmaceuticals for Children Act, which now goes to conference with a slightly different version passed by the Senate in October. Both bills would renew the six-month incentive for five more years, and would add new provisions to help pay for pediatric testing for drugs whose patents have already expired.
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Backers of the measure said the testing incentive has worked even better than they hoped in 1997. "According to the FDA, the pediatric exclusivity provision has done more to generate clinical studies and useful prescribing information for the pediatric population of our country than any regulatory or legislative process to date," said Rep. Billy Tauzin, R-La., chairman of the House Energy and Commerce Committee, which approved the bill.
But opponents said the program has worked too well, providing a windfall to companies with blockbuster drugs by keeping generic competitors off the market. "They tell us the carrot works better than the stick," said Rep. Sherrod Brown, D-Ohio, "but how big does the carrot need to be? Do drug companies need to earn a 600% to 1,500% return on their investment or they will refuse to make sure that their drugs are safe for kids?"
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"Each time we extend patents or exclusivity, it costs patients money," said Rep. Henry Waxman, D-Calif. "If we look at just 25 more drugs that are coming up for exclusivity soon, this law will add at least $11 billion to $12 billion to the nation's healthcare bill."
Even some Democrats who support the program said they were unhappy with the procedure by which the measure was brought to the floor, which barred amendments. Rep. Bart Stupak, D-Mich., had hoped to add language that would prevent exclusivity from being granted until companies changed labeling instructions to reflect the results of the pediatric studies.
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Ira Loss, an analyst with investment research firm Washington Analysis, noted that both the Senate and House bills "contain what has come to be known as the 'glucophage language' that would allow generic versions of drugs such as Bristol-Myers Squibb's Glucophage (metformin HC1) to be marketed without the pediatric indication." Although this language may not remain in the bill, Bristol-Myers is expected to continue its lobbying efforts, and conferees could remove it in conference, Loss noted in a research note., 百拇医药
The House by a vote of 338-86 approved the Best Pharmaceuticals for Children Act, which now goes to conference with a slightly different version passed by the Senate in October. Both bills would renew the six-month incentive for five more years, and would add new provisions to help pay for pediatric testing for drugs whose patents have already expired.
, 百拇医药
Backers of the measure said the testing incentive has worked even better than they hoped in 1997. "According to the FDA, the pediatric exclusivity provision has done more to generate clinical studies and useful prescribing information for the pediatric population of our country than any regulatory or legislative process to date," said Rep. Billy Tauzin, R-La., chairman of the House Energy and Commerce Committee, which approved the bill.
But opponents said the program has worked too well, providing a windfall to companies with blockbuster drugs by keeping generic competitors off the market. "They tell us the carrot works better than the stick," said Rep. Sherrod Brown, D-Ohio, "but how big does the carrot need to be? Do drug companies need to earn a 600% to 1,500% return on their investment or they will refuse to make sure that their drugs are safe for kids?"
, 百拇医药
"Each time we extend patents or exclusivity, it costs patients money," said Rep. Henry Waxman, D-Calif. "If we look at just 25 more drugs that are coming up for exclusivity soon, this law will add at least $11 billion to $12 billion to the nation's healthcare bill."
Even some Democrats who support the program said they were unhappy with the procedure by which the measure was brought to the floor, which barred amendments. Rep. Bart Stupak, D-Mich., had hoped to add language that would prevent exclusivity from being granted until companies changed labeling instructions to reflect the results of the pediatric studies.
, http://www.100md.com
Ira Loss, an analyst with investment research firm Washington Analysis, noted that both the Senate and House bills "contain what has come to be known as the 'glucophage language' that would allow generic versions of drugs such as Bristol-Myers Squibb's Glucophage (metformin HC1) to be marketed without the pediatric indication." Although this language may not remain in the bill, Bristol-Myers is expected to continue its lobbying efforts, and conferees could remove it in conference, Loss noted in a research note., 百拇医药
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