WASHINGTON, April 27, 2011 /PRNewswire/ — Leaders in the battle
with the U.S. Food and Drug Administration to retain metastatic
breast cancer (mbc) as an indication for the drug Avastin today
filed a Freedom of Information Act (“FOIA”) request with the
FDA.
The filers include noted attorney David Rivkin, partner at the
law firm Baker Hostetler (www.bakerlaw.com/davidbrivkinjr/),
Frank Burroughs and Steven Walker on behalf of the Abigail Alliance
for Better Access to Developmental Drugs (www.abigail-alliance.org)
campaigners for increased access to experimental drugs and Terrence
Kalley on behalf of Freedom of Access to Medicines (www.fameds.org), an organization
dedicated to the right of women to retain Avastin as a medical
option for mbc.
The filers are troubled by many actions of the FDA in its review
of the drug Avastin, a drug relied upon by an estimated 17,500
women with incurable mbc. Forty thousand American women die
each year from metastatic breast cancer. Many woman and their
oncologists report great success with the drug, yet the FDA will
remove the indication for mbc, subject to a final appeal by the
drug’s manufacturer on June 28th & 29th at the FDA’s
headquarters in Silver Spring, Maryland.
The FOIA request includes documents regarding the nominations,
appointment, actions and communications of the Oncologic Drugs
Advisory Committee (ODAC) that will hear the appeal. Even though
this panel will render a life and death decision at the June
hearings, no patients or their advocates are allowed to speak and
many may not be able to attend as the FDA claims space
limitations.
The FOIA request also seeks documents regarding the processes by
which the FDA reached its conclusions regarding Avastin, the
communications between the FDA and various outside parties, any
discussions re
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