History

Twenty-Five Years of Saving and Improving Lives

PPTA 25th Annivers logo gold 01 CopyIn 2017, PPTA celebrated its 25th Anniversary. In two and a half short decades, it has become recognized as a global leader and authoritative voice of the plasma protein therapeutics industry.

PPTA represents the private sector manufacturers of plasma-derived and recombinant analog therapies—collectively known as plasma protein therapies—and the collectors of source plasma.

The Association originally formed as the International Plasma Products Industry Association (IPPIA) in 1992. The organization started a European division in 1994, the European Association of the Plasma Products Industry (EAPPI) and in 1998 formed IPPIA in North America. In 2000, EAPPI and IPPIA merged to form the Plasma Protein Therapeutics Association (PPTA). In 2002, PPTA merged with the American Blood Resources Association (ABRA) which added the Source division to represent collectors.

PPTA’s accomplishments demonstrate continued leadership and innovation. The Association’s dedication to quality, safety, and standards has resulted in no reported viral transmissions for more than two decades. In addition, the Association has established constructive dialog and relationships with regulators, policymakers, and patient organizations throughout the world and in doing so, has become a trusted and reliable leader in combatting rare diseases. Finally, PPTA has maintained an unwavering commitment to advocacy efforts that support patient access to care.

Timeline

1970s - 1980s

Established in 1971, the American Blood Resources Association (ABRA) served as the trade group for the private sector plasma collection industry.  Since the inaugural meeting in Memphis, Tennessee, ABRA’s focus grew to represent both collector and manufacturer interests and became a respected voice among regulators and policy makers. Of major importance was the establishment of voluntary guidelines, which paved the way for decades of safety.

1970 American Blood Resources Association (ABRA) established
1978 ABRA offices opened in Annapolis, Maryland, U.S.
1979 Plasma Quarterly (First Industry publication)
Center Managers Workshop (First regulatory training program for plasma collection personnel)
Plasma Forum (First industry symposium)
1980 ABRA/FDA Liaison meeting (First of annual open dialogues to address areas of mutual concern)
Voluntary Industry Recommendations and Guidelines adopted for:
1983  AIDS and donor deferral
1986  Infectious waste management
1987  HIV infection control
1988  Shipment of biological samples & etiologic agents
1989  Laboratory standards

1990 - 1999

As the Association’s activities increased within the public policy arena and with consumer groups in the U.S. and Europe, a demand for targeted, international representation emerged. In response, the International Plasma Products Industry Association (IPPIA) and the European Association of  the Plasma Products Industry (EAPPI) were formed to focus on increased international challenges. Concurrently, ABRA continued its focus on collectors and developed the first voluntary standards program for industry.

1991  Quality Plasma Program established
1992  International Plasma Products Industry Association (IPPIA) formed
1993  National Donor Deferral Registry initiated
1994 Association recommends precautionary measures to further reduce possible risk of transmission of Creutzfeld- Jacob disease (CJD)
European Association of the Plasma Products Industry (EAPPI) formed
Institute of medicine report on HIV and the blood supply
1997 NDDR receives 510(k) clearance
Congressional hearings on safety implications of pooled blood plasma products
1998 QPP Qualified donor standard approved
EAPPI action against danish blood law
IPPIA North America formed
Association activity expanded to Japan
Patient Notification System (PNS) established
Congressional hearings on IVIg shortage
60 Minutes reported on IVIG shortage
GAO Report: Plasma products risks are low if good manufacturing practices are followed
PPTA North America data program established
Ricky Ray Relief Fund Act of 1998
1999 QPP Viral Marker standard implemented
Quality Assurance program established

2000 - 2005

The Plasma Protein Therapeutics Association was created in 2000. IPPIA, EAPPI, and ABRA came together to form ONE VOICE for industry—PPTA. Activities focused on access to therapies, favorable reimbursement practices, quality standards, raising awareness on plasma donation and plasma protein therapies, and global issues.

2000 IPPIA and EAPPI merge to form the Plasma Protein Therapeutics Association (PPTA).
Quality Plasma Program goes international.
2001 Quality Standards of Excellence, Assurance and Leadership (QSEAL) implemented.
Inaugural issue of The Source magazine published.
2002
ABRA merges with PPTA.
www.PPTAglobal.org launched.
European Medicines Agency recognizes PPTA voluntary standards and the safety of plasma from compensated donors.

2004
Therapies exempted from Belgian reimbursement reduction.
Emerging infectious diseases roundtable established.
PPTA France formed.
Removal of the requirement to provide information on the label whether the therapies are made from paid or unpaid donations. According to the Minister of Health, there is no scientific justification for such a requirement.

2005 Relief from Japan’s Yakka Pricing Rul.
ALT Testing Eliminated in Italy.
First PPTA Capitol Hill Fly-in.
Blood Clotting Factors and Alpha-1 Proteinase.
Inhibitor (A1PI) exempted from Medicare.
Competitive Acquisition Program.
A1PI Classified as Orphan Drug.
Blood Clotting Factors Exempted from Preauthorization in Minnesota.

2006 - 2009

2006 Exempted from Belgian tax on turnover for manufacturers.
Separate reimbursement category for therapies created and exempted from New Belgian Hospital financing system.
European pediatric legislation enacted to recognize uniqueness of hemophilia and to avoid invasive new clinical trial requirements.
ALT and Neopterin Testing Eliminated in Austria.
Japan reimbursement price system reform provided manufacturer compensation for costs of required safety measure.
Albumin literature database website launched.

2007 IVIG therapies reimbursed at Medicare ASP and removed from multiple-source drug listing.
Office of Inspector General issued IVIG report.
IVIG therapies reinstated into World Health Organization’s Essential Medicines list.
ALT testing eliminated in Japan.
New European Parliament Policy Outreach Program initiated.
Congenital conditions treated with plasma protein therapies eliminated from new clinical trial requirements in European Union.
Source industry image campaign initiated.

2008 Donatingplasma.org launched.
“Gift of Life” Documentary Produced.
Source outreach campaign on Facebook, Rural radio and Google.
PPTA Becomes voting member on Health and Human Services Advisory Committee on Blood Safety and Availability (ACBSA).

2009 PPTA Deutschland Formed.
FIND-ID Initiative Implemented.
Donor History Questionnaire Approved.
Plasma Protein Therapies Month resolution passed in Texas and Florida.
IVIG Literature database website launched.

2010 - 2012

2010 “Bad Blood” documentary premiered.
IQPP Cross Donation Management standard implemented.
www.Donatingplasma.org translated into German (www.dieplasmaspende.org).
ALT and Neopterin testing eliminated in Austria.
Plasma Protein Therapies Month resolutions passed in Minnesota and California.
Plasma protein therapies exempt from Belgium reimbursement reduction.

2011 “Becoming a Donor” video produced in German and English with Spanish subtitles.
Joint PPT/FDA Workshop: Thromboembolic events in Immune Globulin patients.
IRS 1099 tax reporting requirements for U. S. donors repealed.
State Patient Access Coalition (SPAC) formed.
Health Technology Assessment models developed to address cost-containment issues.
Clotting Factors excluded from Mandatory Managed Care Law in Florida.
Plasma Protein Therapies Month resolutions passed in California and Florida.
PPTA Deutschland nominated to National Advisory Committee in Germany (AK Blut, Ministry of Health).

2012 Clotting Factors Sales Tax rejected in New Jersey.
Florida funded Severe Combined Immunodeficiency Disease (SCID) testing within the Newborn Screening Program.
IQPP continues to grow in the EU with 20 new centers achieving first-time certification, including the first two in the Czech Republic.
PPTA’s regulatory workshop “U.S./EU Inspections: Quality/Compliance Challenges & Solutions” provided a global perspective on challenges faced by plasma collectors and fractionators.
Decision analysis models for prophylaxis in hemophilia, sepsis with albumin, and therapeutic demand for Ig created.

2013 - 2015

2013 CMS begins consideration of Competitive Bidding for durable medical equipment, which would include the administration of SCIg.
The 30th Anniversary of the Orphan Drug Act (ODA) was recognized by the FDA.
PPTA published "Treatment for Life for Severe Haemophilia A- A Cost Utility Model for Prophylaxis vs. On-demand Treatment" in collaboration with physicians, patient groups and health economists in the peer-reviewed journal Haemophilia (2013), 1-11.
The EU Data Program launched.

2014
 PPTA secured a meeting with the World Health Organization (WHO) to express concerns over the Rome Declaration.
The FIND-ID Network presented to hundreds of German physicians at several congresses and training events called “Update für den Arztpraxis.”
PPTA and Latin American patient organizations met with the Ministry of Health in Montevideo, Uruguay, advocating for extension of prophylaxis into adult years.
Alabama passed legislation to reduce plasma donation age from 19 to 18.
PPTA coordinated Enterovirus D68 (EV-D68) testing of Ig by the CDC which concluded… “all products had high titers against the EV-D68 and no major differences between products were observed.”

2015 The focus on the EU Blood Directive continues: Two workshops held gathering company experts to define key issues and offer solutions.
Poland ceased its initiative to treat plasma protein therapies as generic drugs.
PPTA and IPOPI successfully engaged in Ecuador to avoid a reduction in reimbursement.
IVIG is excluded from a reimbursement reduction in Colombia.
PPTA identified major flaw in codification in Inventory Hold provision of Final Rule, Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use. Letter from PPTA highlighted issue and FDA clarified its position in response.
Cross Donation Check System launched.

2016 & Beyond

PPTA continues to focus on challenges and opportunities to promote the importance of plasma donation and plasma protein therapies. PPTA’s accomplishments continue to reflect its mission of promoting the availability of and access to safe and effective plasma protein therapeutics for all patients around the world.

2016 Romania recognizes the specificity of the plasma protein therapeutic sector and agreed to apply a different price setting methodology
SCIg successfully exempted from Durable Medical Equipment (DME) Competitive Bidding in Medicare
Nebraska passed legislation to specify that 18 year olds can donate plasma
FDA acknowledged that the safety of plasma protein therapies are not affected by Zika virus
European Plasma Alliance (EPA) established
New IQPP donor fluid administration standard implemented
PPTA partnered with Abbott on BE THE 1TM Campaign

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