2014

Plasma Protein Therapeutics Association Supports Patient-Centered Outcomes Research Act of 2009

ANNAPOLIS, Md. July 20 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) strongly supports S.1213, the Patient-Centered Outcomes Research Act of 2009, a bill that would establish a nonprofit corporation called the Patient-Centered Outcomes Research Institute to contract with appropriate Federal agencies or the private sector to conduct comparative effectiveness research (CER).

In a letter to Sen. Max Baucus (D-MT), chairman of the Senate Finance Committee and Sen. Kent Conrad (D-ND), chairman of the Senate Budget Committee, PPTA stated that the inclusion of a provision in the legislation requiring that an expert advisory panel for rare diseases be convened each time a rare disease is proposed as a CER topic is a critical safeguard for patients with conditions such as alpha-1 antitrypsin deficiency, bleeding disorders such as hemophilia and von Willebrand disease and primary immune deficiency diseases. Plasma protein therapies are used in the treatment of these diseases and disorders, which are genetic, chronic, and life threatening. Very often, plasma protein therapies are the only viable treatment option for these patients.

PPTA believes that consulting with an expert advisory panel comprised of patient and physician experts for rare disease each time a rare disease is addressed as part of a proposed CER study topic is imperative to ensure the specific rare disease patient population directly affected by the proposed study is adequately represented. Furthermore, the panel would also determine whether such a study is even appropriate.

The letter noted that PPTA is also extremely encouraged about a provision that would allow an expert panel on a rare disease to include "a representative of each manufacturer of each medical technology that is included under the relevant topic, project, or category for which the panel is established."

The Association went on to state in the letter that it hopes that this important piece of legislation will be included in the Committee on Finance's broader health care reform legislation. "While we appreciate the efforts of many members of the Senate Committee on Health, Education, Labor and Pensions during its mark up of the Affordable Health Choices Act, S.1213 is the far superior CER legislation in the 111(th) Congress and must be the starting point in the health care reform debate," stated Julie Birkofer, PPTA's Vice President, North America.

To view PPTA's letter online, go to: http://www.pptaglobal.org/UserFiles/file/PPTA%20Letter%20of%20Support%20on%20S%20%201213%20(Baucus-Conrad%20CER)%20FINAL.pdf.

For more information, please contact Kara Flynn at 443-458-4669 or kflynn@pptaglobal.org. More information about PPTA can be found at www.pptaglobal.org.

The Plasma Protein Therapeutics Association (PPTA) is the trade association and standard setting organization for the world's major producers of plasma-derived and recombinant analog therapies (collectively, "plasma therapies"). These therapies are used by more than 1 million people worldwide each year to treat a variety of diseases and serious medical conditions. PPTA members produce over 80 percent of the plasma therapies for the United States market and more than 60 percent worldwide. Some of the critical therapies produced by PPTA members include: blood clotting factors for people with hemophilia, intravenous immune globulin used to prevent infections in people with immune deficiencies and other serious conditions, and alpha-1 proteinase inhibitor used to treat people with alpha-1-antitrypsin deficiency, also known as genetic emphysema.

SOURCE Plasma Protein Therapeutics Association (PPTA)



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