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U.S. Healthcare Reform ... Biotechnology, Politics & Healthcare
Colleagues,
As reported in Xconomy ...
... so we embark on a new era of healthcare ... there are two small bits in the Patient Protection and Affordable Care Act that are immediately relevant and timely for the biotechnology industry. One provides tax breaks for smaller biotechnology companies, while the other simplifies some aspects of the regulatory landscape and adds some complicated wrinkles...
...The Therapeutic Discovery Project Credit provides “an amount equal to 50 percent of the qualified investment for such taxable year with respect to any qualifying therapeutic discovery project,” permitting some of the costs for pre-clinical research, clinical trials and other research protocols to be reduced. It appears that it will be limited to organizations with fewer than 250 employees. The total amount of the credit is $1 billion...
... The ... Approval Pathway For Biosimilar Biological Products, provides real clarity on an important regulatory issue. This section permits biologics—the complex therapeutics produced by most biotechnology companies—to maintain 12 years of market exclusivity after FDA
approval of the product ...
... However, there is one more worrisome hurdle that this legislation places in front of anybody who wants to make a follow-on biologic that could compete with an innovator’s product.
As reported in Xconomy ...
... so we embark on a new era of healthcare ... there are two small bits in the Patient Protection and Affordable Care Act that are immediately relevant and timely for the biotechnology industry. One provides tax breaks for smaller biotechnology companies, while the other simplifies some aspects of the regulatory landscape and adds some complicated wrinkles...
...The Therapeutic Discovery Project Credit provides “an amount equal to 50 percent of the qualified investment for such taxable year with respect to any qualifying therapeutic discovery project,” permitting some of the costs for pre-clinical research, clinical trials and other research protocols to be reduced. It appears that it will be limited to organizations with fewer than 250 employees. The total amount of the credit is $1 billion...
... The ... Approval Pathway For Biosimilar Biological Products, provides real clarity on an important regulatory issue. This section permits biologics—the complex therapeutics produced by most biotechnology companies—to maintain 12 years of market exclusivity after FDA
approval of the product ...
... However, there is one more worrisome hurdle that this legislation places in front of anybody who wants to make a follow-on biologic that could compete with an innovator’s product.
Upon application for FDA approval, the company developing the follow-on biologic has to turn over all the relevant documents to the company that owns the original reference therapeutic. Not upon approval, but upon application. To its direct competitor...
... Perhaps I might be misreading the relevant paragraphs. If so, maybe someone could assuage my concerns...
Read on for the full article at: http://www.xconomy.com/national/2010/03/24/healthcare-reform-gave-b...
ENJOY!
CC
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