[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Extensions of Remarks]
[Page 8362]
[From the U.S. Government Publishing Office, www.gpo.gov]




          HONORING THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION

                                 ______
                                 

                            HON. KEVIN BRADY

                                of texas

                    in the house of representatives

                         Tuesday, June 5, 2012

  Mr. BRADY of Texas. Mr. Speaker, I rise today to honor the Plasma 
Protein Therapeutics Association (PPTA) as that organization celebrates 
its 20th anniversary.
  Since PPTA's founding in 1992, the organization has been at the 
forefront of promoting innovation and patient access to safe and 
effective therapies used to treat rare and chronic conditions. PPTA is 
a globally active trade association, representing six plasma protein 
therapy manufacturers in the United States, and 16 plasma collection 
companies that operate nearly 400 plasma collection centers across the 
country.
  PPTA is distinguished in the pharmaceutical and biologics industries 
for the Association's dedication to the continual innovation of 
therapies for rare disease patients. Today, plasma protein therapies 
are used to treat a range of rare diseases including primary immune 
deficiency diseases; neurological disorders such as chronic 
inflammatory demyelinating polyneuropathy; hemophilia, von Willebrand 
disease and other bleeding disorders; and alpha-1 antitrypsin 
deficiency, as well as specialty immune globulin therapies that treat a 
range of conditions. Recognizing the unique concerns of the patients 
living with these rare diseases, PPTA continues to act as a diligent 
advocate for the protection of therapeutic innovation and patient 
access to plasma protein therapies. One example of that commitment is 
the Association's strong support of my bill, the Medicare IVIG Access 
Act, H.R. 1845, which will make whole the home infusion benefit for 
patients with primary immune deficiencies. In addition to my work on 
this legislation, my interest, support, and commitment extend to all of 
the rare disease patients treated with life-saving plasma protein 
therapies, and I'm proud to work on issues so vital to the health of 
these fragile groups of patients.
  In addition to the Association's outstanding advocacy, PPTA has also 
led the industry in quality and safety assurance. In 2000, PPTA and its 
members implemented the Quality Standards of Excellence, Assurance and 
Leadership (QSEAL) as voluntary standards that complement FDA 
regulatory requirements for manufacturing plasma protein therapeutics. 
QSEAL certification provides a pathway for industry participants to 
provide independent certification of adherence to the QSEAL standards. 
The QSEAL program works in concert with the International Quality 
Plasma Program (IQPP), instituted more than 20 years ago to help ensure 
the safety of plasma used to produce lifesaving therapies and plasma 
donors.
  A global organization headquartered in the United States, with an 
office in Belgium, and that serves the needs of chronic, rare disease 
patients around the world, PPTA and its members should be commended for 
their ongoing commitment to supporting patient access to innovative, 
safe and effective treatments.

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