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
  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
2005   Relief from Japan’s Yakka Pricing Rule
  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 measures
  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
Donatingplasma.org translated into German
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