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Theresa Toigo, RPh, MBA Director

Office of Special Health Issues

Food and Drug Administration (FDA)

5600 Fishers Lane

HF-12, Room 9-49

Rockville, MD 20857

Theresa.Toigo@fda.hhs.gov

 

Dear Ms. Toigo,

 

We are people with Hemophilia and their supporters.

 

We recognize and appreciate the recent FDA publication of rules to clarify and expand the process whereby some patients may obtain access to drugs in development (Expanded Access to Investigational Drugs for Treatment Use – Federal Register August 13, 2009) .  However, many people with Hemophilia have run out of approved treatment options for hepatitis C (HCV) and are rapidly running out of time.  Meanwhile, promising drugs for HCV are under investigation.  We request that FDA focus on the urgent problem of access to life-saving HCV drugs for our community.

In summary the petition says:

People with Hemophilia, particularly those with advanced HCV and/or co-infection with HCV/HIV, desperately need access to promising investigational HCV therapies.  We call on FDA to:

 

Coordinate a public hearing for all stakeholders, including consumers, healthcare providers, medical industry representatives, and public officials to facilitate approval of promising HCV drugs and drug combinations;

 

Provide an ‘expanded access’ pathway to combinations of two or more promising HCV drugs for people infected with HCV who are poor candidates for P-IFN/RBV therapy;   

 

For persons who have HCV which is ‘difficult to treat / low likelihood of treatment success,’ and for whom P-IFN/RBV may be indicated, provide access to regimens which add promising (preferably oral) agents to the standard therapy.  Priority should be given to protocols which add two or more such promising agents.   

 

The petition requests that FDA recognize the crisis of HCV in People with Hemophilia and take definite steps to allow them access to promising HCV investigational drugs, beyond the scope of any current clinical trials.

 

We, the petitioners, look forward to engaging with you on this urgent concern.

 

Sincerely,

Individuals

Mark Antell, Person With Hemophilia (PWH)

Paul Brayshaw, PWH

David Elliott

Richard M. Lawrence

Dianne Shangold

L. Sabrina Adams

Debby Ballweg

Magdalen Ballweg

Florence and Jim Hellenbrand

Jeff and Judy Hellenbrand

Terry and Jamie Hellenbrand

Sue and Chuck Ziegler

Kevin and Sue Hellenbrand

Paul and Julie Hellenbrand

Jay and Michelle Hellenbrand

Jodi and Jeff Hellenbrand

Sandi Qualley

James DeArmon

Eileen Prophett

Wint Weisman

Joanne Intemann

Pat McFadden

Franklin Wayne Roberts

Miriam Goldstein

Patricia DeRatto

Cheryl Sherman

Karen Nolden

Shelby Klingaman

Kim and Martin Wood

Cathy Crapser

Faye Wood

Anna Rorick

Mari Droney

Sherenath Bishu

John McNeil

Jennifer White

Nicolas Cady

 

Non-Profit Organizations

Hemophilia Federation of America

Frank Burroughs, Abigail Alliance for Better Access to Developmental Drugs

 

Commercial Organizations

Tim Duncan, RN, CCRN, CRTT, Account Executive Grifols

Mandi White, Wyeth Hemophilia Specialty Manager

Sandy Deierhoi, Director of Marketing, Factor Support Network

 

 

Responses should be addressed to:

Mark Antell*

my-time@earthlink.net, and,

Paul Brayshaw**

pbrayshaw@cox.net

 

*Mr. Antell is a hemophiliac who also has HCV.  **Mr. Brayshaw is a person with hemophilia and is employed by a home health care company.   Other than an interest in saving our lives, and the lives of other people with hemophilia and HCV, neither of us have a conflict of interest in the matter of expanded access to HCV therapies.

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