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PPTA Praises Legislation That Protects the Treatment of Rare Diseases
Date:7/29/2011

FDA-indicated solely for the treatment of one or more rare disease from their annual fee liability. The legislation is bipartisan and budget neutral.

Plasma protein therapies, which include plasma-derived therapies and recombinant blood clotting factors (a biotechnology product), are biological products that are not interchangeable, and no generics or substitutions exist. These unique therapies are used every day to treat people with bleeding disorders including hemophilia, which causes painful internal bleeding and debilitating joint damage; primary immunodeficiency diseases, which render the body defenseless from even the most common infections, often leading to pneumonia and other serious illnesses; and alpha-1 antitrypsin deficiency, also known as genetic chronic obstructive pulmonary disease (COPD), which severely damages the liver and lungs. Additionally, a plasma protein therapy, albumin, is used in critical care settings, when treating severe trauma, burns and during major surgery.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.


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SOURCE Plasma Protein Therapeutics Association (PPTA)
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