or the Gift to the Generic Drug Industry Act...whatever you want to call it...but here's the coup de grace according to an article about the so called Access To Lifesaving Medicines Act in Scrip Magazine:
"The legislation would authorise the FDA to approve abbreviated applications for biologicals that are "comparable" to the reference products approved under the Public Health Service Act.
Comparability means no clinically meaningful differences in safety, purity and potency, based on non-clinical studies and clinical studies as necessary. An applicant also must demonstrate that the comparable product shares the "principal molecular structure features" of the reference product and the same mechanism of action, if known. "
In otherwords, generic firms would have a separate and short track for developing biotech products based on the same mechanism of action without having to go through all the time and expense that a biotech firm has to go through. Which means all you have to do if you are a generic company is a little reverse engineering and try to punch a couple holes in a patent or two of a biotech product and claim you can whip up the same product with the same molecuar structure features --whatever the hell that means.
The bill assumes that biologics are therapeutically interchangeable or can be made so. Actually, the bill deals with this problem by simply avoiding the issue altogether by assuming -- incorrectly -- that the same mechanisms of action equals no clinical meaningful difference or should be the foundation for approval.
The bill gives the generic firms tax breaks and market monopolies as incentives to attack the patents of biotech companies (what else is this aggressive effort to promote interchangeability at any time during the patent period) and ban the ability of biotechs to produce their own biogeneric products even though that might be a safer and more effective product or in fact their might be scientific question as to interchangeability.
This Clinton Schumer bill is a car bomb driven up to door of biotech innovation that will explode years from now. It will lead to massive litigation and game playing. Rather than worrying about the price of biotech products, policymakers should encourage the promotion of personalized and targeted medicine and nanontech delivery systems that will lead to more appropriate dosing for the right patients at the right time.
"The legislation would authorise the FDA to approve abbreviated applications for biologicals that are "comparable" to the reference products approved under the Public Health Service Act.
Comparability means no clinically meaningful differences in safety, purity and potency, based on non-clinical studies and clinical studies as necessary. An applicant also must demonstrate that the comparable product shares the "principal molecular structure features" of the reference product and the same mechanism of action, if known. "
In otherwords, generic firms would have a separate and short track for developing biotech products based on the same mechanism of action without having to go through all the time and expense that a biotech firm has to go through. Which means all you have to do if you are a generic company is a little reverse engineering and try to punch a couple holes in a patent or two of a biotech product and claim you can whip up the same product with the same molecuar structure features --whatever the hell that means.
The bill assumes that biologics are therapeutically interchangeable or can be made so. Actually, the bill deals with this problem by simply avoiding the issue altogether by assuming -- incorrectly -- that the same mechanisms of action equals no clinical meaningful difference or should be the foundation for approval.
The bill gives the generic firms tax breaks and market monopolies as incentives to attack the patents of biotech companies (what else is this aggressive effort to promote interchangeability at any time during the patent period) and ban the ability of biotechs to produce their own biogeneric products even though that might be a safer and more effective product or in fact their might be scientific question as to interchangeability.
This Clinton Schumer bill is a car bomb driven up to door of biotech innovation that will explode years from now. It will lead to massive litigation and game playing. Rather than worrying about the price of biotech products, policymakers should encourage the promotion of personalized and targeted medicine and nanontech delivery systems that will lead to more appropriate dosing for the right patients at the right time.
