Medical Technologies

The US Orphan Drug Tax Credit

From the FDA page on the Orphan Drug Tax Credit.

Incentives

TAX CREDIT
(See Footnote 1 below)
FOR TESTING EXPENSES FOR
DRUGS FOR RARE DISEASES OR CONDITIONS

Introduction
Section 45C of the Internal Revenue Code of 1954 allows a credit against tax, up to 50 percent of certain clinical testing expenses related to the use of a drug for a rare disease or condition after it is designated as an orphan drug.

Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)

(Cite as Molly Redfield Ward, Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs), KEI Research Note 2010:3)

A PDF version of this document is available here.

Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)
KEI Research Note 2010:3

August 5, 2010

Molly Redfield Ward[1]

Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products for Rare and Neglected Pediatric Diseases

Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures


On the topic of

Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products.

James Love
Knowledge Ecology International
4 August 2010

2010 Fabrazyme March-In Request

NIH rejects Fabrazyme March-In Petition

Data points for Fabrazyme prices

Fabrazyme is a very expensive biological product used to treat Faby's Disease, a rare genetic disorder. A typical regime is 1 milligram per kilo of body weight every two weeks. A person weighing 70 kilos would thus require two 35 mg vials every two weeks (26 times per year).

The following are data points on prices for Fabrazyme

USA
Source: Fabry patient (See invoice), August 1, 2010
35 mg vial: $4,879.73 USD

Sweden
Source: Kirsten Myhr, July 22, 1010

Public and Private Sector Research for Fabry's Disease

KEI Research Note 2010:2
23 July 2010


Public and Private Sector Funded Research for Fabry's Disease

Introduction

Fabry's disease is a rare genetic multisystemic disorder associated with progressive lipid accumulation and cell damage, leading to a variety of aliments, including some that are life-threatening, including kidney failure, heart attacks and strokes. The disease was identified in 1898 independently by both Dr William Anderson in England and Dr Johannes Fabry in Germany. Other names for the disease include:

US NGO’s Call For George Washington University to Cease Industry-Sponsored Intellectual Property Training in India

On June 7, 2010 medicine access advocacy groups joined together in asking that George Washington University (GWU) put a stop to its industry-sponsored intellectual property (IP) summits and to take an academic, evidenced-based approach to conferences it conducts in India.

Why is there resistance to prize funds?

I was recently asked the following question:

Jamie
What is your view on the treatment of prize funds? By all standards it is treated as a radical off the wall proposal when in fact it is market based. Why is there so much resistance?

My response was as follows:

USTR pressures Taiwan on pricing and reimbursement of pharmaceuticals and medical devices

This from USTR's 2010 Trade Policy Agenda and 2009 Annual Report:

UNDP ranks the U.S. 26ths in term of life expectancy at birth

As the U.S. considers health reform legislation, it is useful to review how countries rank in terms of life expectancy at birth.

From the 2009 UNDP Human Development Report statistical appendix:

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