H.R. 3590 is called the Patient Protection and Affordable Care Act of 2009. The bill became law on December 24, 2009. It is published on the Library of Congress' website, Thomas.gov. Now that the patient Protection and Affordable Care Act of 2009 has become federal law, it is important to know what the law says. This article addresses Title VII and VIII of what is commonly called "ObamaCare." These titles detail licensing biologicals, expanding the pharma drug market for children and the underserved, and the CLASS Act for long term care.
H.R. 3590, Title VII, Subtitle A: The Biologicals Price Competition and Innovation Act of 2009
A biological product is anything that comes from a living organism and is used to prevent or treat disease. Examples of biologicals are vaccines and hormone extracts. The Public Health Service Act has been amended so that anyone who wishes to get a license for a biological product that is similar to a currently licensed biological product may do so. The Department of Health and Human Services will license the product if it is interchangeable with a currently licensed biological.
If a licensed biological is under litigation, meaning there is legal action involving the biological, HHS is prohibited by law from licensing a second, bio-similar product. HHS may not approve an application for a second biological until 12 years after the first biological was licensed.
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