Navigation Links
PPTA Applauds Preserving Access to Orphan Drugs Acts
Date:6/14/2013

ANNAPOLIS, Md., June 14, 2013 /PRNewswire/ -- The Plasma Protein Therapeutics Association (PPTA) commends the Preserving Access to Orphan Drugs Acts, bipartisan legislation that makes an important policy clarification and will remove a barrier to research and development of rare disease therapies.

Representative Jim Gerlach (R-PA), introduced H.R. 2315 with lead cosponsor Rep. Richard Neal (D-MA), and Senator Patrick Toomey (R-PA), introduced an identical bill, S. 1128, with lead cosponsors Sens. Robert Casey (D-PA) and Mike Crapo (R-ID). "Representative Gerlach and Senator Toomey have demonstrated exceptional leadership and commitment to the rare disease community with this legislation," Julie Birkofer, PPTA Senior Vice President, North America said.

The budget neutral bills will clarify the orphan drug exclusion from the annual pharmaceutical fee by basing the exclusion on whether the therapy is solely approved for marketing by the Food and Drug Administration (FDA) to treat a rare disease or condition. Under current law, a product only is excluded from paying the annual fee if it has claimed the Orphan Drug Act tax credit. This has left many plasma protein therapies unable to qualify for the exclusion and disproportionately affects these lifesaving rare disease therapies. In the U.S., a rare disease or condition is generally defined as one affecting less than 200,000 persons.

"Claiming of the Orphan Drug Act tax credit is not the best way to define all rare disease therapies; many are left out of the exclusion despite treating orphan conditions," Birkofer said. "The optimal way to meet the needs of patients who rely on PPTs is to clarify the provision in the Affordable Care Act to recognize rare diseases and this bill achieves that," she added.

Plasma protein therapies include plasma-derived therapies and recombinant blood clotting factors. These unique, non-interchangeable biological products for which no generics or substitutions exist are used to treat bleeding disorders, primary immunodeficiency diseases, alpha-1 antitrypsin deficiency, and certain rare neurological disorders

About PPTA
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 used for fractionation. PPTA member companies produce approximately 80% of the therapies in the U.S. and 60% of those manufactured in Europe. PPTA works globally to advocate for access to and affordability of therapies; engage in constructive dialogue with regulatory authorities and collaborate with patient organizations. PPTA also administers standards and programs that help ensure the quality and safety of plasma, manufacturing, donors and patients.


'/>"/>
SOURCE Plasma Protein Therapeutics Association (PPTA)
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. CHPA Applauds Alabama Senates Passage of Anti-Meth Bill
2. CHPA Applauds Alabamas Adoption Of HB 363
3. Lilly Applauds Law Enforcement Officials for their Successful Investigation and Recovery of Pharmaceuticals Stolen from Connecticut Distribution Center
4. CHPA Applauds Arizonas Adoption Of HB 2263
5. Omega Laboratories Applauds the Adoption of Enzyme Immunoassay (EIA) by Major Hair Testing Laboratories
6. Obesity Care Continuum (OCC) Applauds FDA for Approval of New Obesity Drug
7. Novation Applauds FDAs Unique Device Identification Rule
8. American Academy of Pain Medicine Applauds FDA Action to Enhance Patient Safety on Prescribing Opioids; Offers AAPM Safe Opioid Prescribing Course as Educational Model
9. Mylan Applauds Signing of Landmark "Food and Drug Administration Safety and Innovation Act"
10. ADVENTRX Applauds Inclusion of Rare Diseases Provisions in the FDA Safety and Innovation Act
11. CRN Applauds Introduction Of Designer Anabolic Steroid Control Act
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/6/2017)... TORONTO , Sept. 6, 2017 /PRNewswire/ ... new knowledge and skills while treating their ... for hands-on experience without involving patients. Simulation ... skills. Clinicians can carry out procedures, refine ... at risk. Integration of new technology, such ...
(Date:9/5/2017)... KEYSTONE, Colo. , Sept. 5, 2017 ... their XR-29 DoseCheck solution. Scannerside DoseCheck is a third-party ... update existing CT scanners and allows compliance with current ... The Sapheneia-Scannerside proprietary XR 29 DoseCheck solution is specifically ... notifications and alerts of potential radiation doses over a ...
(Date:9/5/2017)... Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ... company focused on the development of oral drug delivery ... meeting with the U.S. Food and Drug Administration (FDA) ... At the meeting, the ... submission of ORMD-0801, would be a Biologics License Application ...
Breaking Medicine Technology:
(Date:9/19/2017)... ... September 19, 2017 , ... Spain’s popular line ... Laboratories, is coming soon to RonnieColemanNutrition.com. , ACPG Laboratories has been in ... trusted, well-respected brand reliant on the healing properties of plants, a proven science ...
(Date:9/19/2017)... ... September 19, 2017 , ... ... to serve as strategic adviser to the animal healthcare division of Sonoma ... Bridge Animal Referral Center (BARC) in Edmonds, Washington, which specializes in compassionate ...
(Date:9/19/2017)... ... , ... Premiere Long Island dental office Gold Coast Smiles is pleased to ... dentists in America under age 40 by Incisal Edge magazine. , Incisal Edge ... the best 40 dentists under the age of 40 renowned for medical innovations and ...
(Date:9/19/2017)... ... September 19, 2017 , ... When it comes to household ... deserve clear instructions on how to keep babies and toddlers safe, and there's no ... Safety Month. , Great Time to Check Labels, Brands that sell all kinds of ...
(Date:9/19/2017)... ... September 19, 2017 , ... Emergency ... the Certified Emergency Nurse (CEN®) certification according to a large-scale study ... of certification study, conducted by the Human Resources Research Organization (HumRRO) in late ...
Breaking Medicine News(10 mins):