不注册商品药制造厂商要求结束儿科药物专营性
NEW YORK (Reuters Health) - The generic drug industry's lead trade group is urging Congress not to reauthorize a provision of federal law that awards brand-name drugmakers "monopolies" for testing their drugs in children.
The Generic Pharmaceutical Association (GPhA) is supporting a proposed tax credit in lieu of the current "pediatric exclusivity" program, which provides 6 additional months of marketing exclusivity to drugmakers in exchange for pediatric studies of their drugs.
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Tax credits, the GPhA said, would be sufficient to offset and even reward pediatric testing.
"It benefits both children, who will continue to be served by pediatric studies performed under the incentive of tax credits, and consumers, who bear a disproportionate burden from 6 additional months," said William Nixon, president of the Washington, DC-based association.
GPhA is speaking out as Congress considers whether to extend the pediatric exclusivity provision, set to expire on January 1, or legislate some other approach to encourage drugmakers to conduct pediatric testing.
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"What we're trying to do is call attention to what pediatric exclusivity has meant over the past 4 years," GPhA spokesman Clay O'Dell explained. "We feel that exclusivity has not been good for the consumer, and we feel that while it has led to pediatric testing...it seems it was simply an effort to force pharma to probably be doing the tests that they should have been doing in the first place," he told Reuters Health.
As the deadline for the provision's sunset approaches, debate over the issue has heated up.
, http://www.100md.com
The industry trade group Pharmaceutical Research and Manufacturers of America supports continuation of the provision, which was enacted as part of the Food and Drug Administration Modernization Act of 1997. Spokesman Jeff Trewhitt said that the pediatric exclusivity provision has been effective and recognizes the "costs and special considerations" of undertaking pediatric drug studies.
Public Citizen, which is takes an opposing view, said that drugmakers should be required to test all new medications likely to be used in children, as a condition of FDA approval. It is calling on Congress to scrap pediatric exclusivity (see Reuters Health report, July 16).
, http://www.100md.com
Like Public Citizen, GPhA is irked by the "windfall" that brand-name drugmakers enjoy at the purported expense of taxpayers. The first 4 years of pediatric exclusivity has cost consumers more than $4 billion in profits to drugmakers, the generics group charged.
Some $350 million of that, it said, is due to extensions of patents for the cardiovascular drug Vasotec (enalapril maleate), the hypertension drug Cardura (doxazosin mesylate), and the anti-anxiety drug BuSpar (buspirone).
GPhA is not saying which drugs should or should not be tested in children, O'Dell insisted. The point, he said, is that providing extended patent protection on drugs used by seniors, many of whom are on fixed incomes, and by low-income individuals prevents those prices from coming down for 6 months., http://www.100md.com
The Generic Pharmaceutical Association (GPhA) is supporting a proposed tax credit in lieu of the current "pediatric exclusivity" program, which provides 6 additional months of marketing exclusivity to drugmakers in exchange for pediatric studies of their drugs.
, 百拇医药
Tax credits, the GPhA said, would be sufficient to offset and even reward pediatric testing.
"It benefits both children, who will continue to be served by pediatric studies performed under the incentive of tax credits, and consumers, who bear a disproportionate burden from 6 additional months," said William Nixon, president of the Washington, DC-based association.
GPhA is speaking out as Congress considers whether to extend the pediatric exclusivity provision, set to expire on January 1, or legislate some other approach to encourage drugmakers to conduct pediatric testing.
, 百拇医药
"What we're trying to do is call attention to what pediatric exclusivity has meant over the past 4 years," GPhA spokesman Clay O'Dell explained. "We feel that exclusivity has not been good for the consumer, and we feel that while it has led to pediatric testing...it seems it was simply an effort to force pharma to probably be doing the tests that they should have been doing in the first place," he told Reuters Health.
As the deadline for the provision's sunset approaches, debate over the issue has heated up.
, http://www.100md.com
The industry trade group Pharmaceutical Research and Manufacturers of America supports continuation of the provision, which was enacted as part of the Food and Drug Administration Modernization Act of 1997. Spokesman Jeff Trewhitt said that the pediatric exclusivity provision has been effective and recognizes the "costs and special considerations" of undertaking pediatric drug studies.
Public Citizen, which is takes an opposing view, said that drugmakers should be required to test all new medications likely to be used in children, as a condition of FDA approval. It is calling on Congress to scrap pediatric exclusivity (see Reuters Health report, July 16).
, http://www.100md.com
Like Public Citizen, GPhA is irked by the "windfall" that brand-name drugmakers enjoy at the purported expense of taxpayers. The first 4 years of pediatric exclusivity has cost consumers more than $4 billion in profits to drugmakers, the generics group charged.
Some $350 million of that, it said, is due to extensions of patents for the cardiovascular drug Vasotec (enalapril maleate), the hypertension drug Cardura (doxazosin mesylate), and the anti-anxiety drug BuSpar (buspirone).
GPhA is not saying which drugs should or should not be tested in children, O'Dell insisted. The point, he said, is that providing extended patent protection on drugs used by seniors, many of whom are on fixed incomes, and by low-income individuals prevents those prices from coming down for 6 months., http://www.100md.com
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