FDA analyst Dana Delman's insulting letter on ddI to Thai NGOs

[James Love <love@cptech.org>]

April 20, 1999

Stuart Nightingale
US FDA


Dear Dr. Nightingale,

I just received a copy of a note from Dana Delman, a policy 
analyst for the FDA Executive Secretariat,  that was sent to
the Thai NGO  Access to Treatment group.  The Delman letter was 
a response to a letter the Thai group sent Secretary Shalala in
September 1998, asking for a review of the reasonable pricing 
of ddI, and important AIDS drug.

The FDA letter is a baffling response to the Thai NGO group's
request to Secretary Shalala.  As FDA analyst Dana Delman 
quickly points out, the FDA plays no role in the determining the 
reasonable prices of drugs.  Why then did Secretary Shalala ask 
the FDA to  respond on her behalf?  Why did the FDA itself elect 
to respond? 

The patronizing note that the ddI patent expires in the year 2006
was particularly offensive, and the reminder that patent rights 
are important as a stimulus for private investment was also 
bizarre, in the  context of ddI.  ddI is a US government invention.   
The patent on ddI is held by the US government.  The decision to 
give a private firm the exclusive rights to market ddI in Thailand
is a US government decision.  

There are 1 million HIV/AIDS patients in Thailand, the vast 
majority of which cannot afford ddI, as the drug is priced 
by Bristol-Myers Squibb.  The patients who are dying in
Thailand are asking Secretary Shalala to review the price of ddI, 
to determine if Bristol-Myers Squibb is living up to the terms of 
its license for ddI, which includes a clause on reasonable 
pricing.   This isn't a joke, and a half baked response like the 
one from Dana  Delman is insulting.  

Who at the FDA was involved in this?

    
   Sincerely,


   James Love, Consumer Project on Technology
   love@cptech.org    http://www.cptech.org



<------------------------------------------------------------------->
This is the note I received from Dr. David Wilson, with MSF-Thailand.

20/4/99


Dear Joelle / Jamie
For your information, the Thai NGO Access to treatment group has now
received a reply to the letter sent to Donna Shalala about DDI 
pricing. The reply is from Dana Delman, Policy Analyst, FDA Executive 
Secretariat.

For what it's worth (not much), here is the text:

Dear Mr Cawthorne

Your February 16, 1999, letter to Secretary Shalala was forwarded to the
Food and Drug Administration (FDA) for response. We sympathise with the
problems caused by AIDS drug pricing in general, and your specific
concern
with the cost of ddI.

FDA is responsible for ensuring that drug products are safe and
effective for use as directed on the labeling. Neither FDA nor 
other segments of the U.S.Federal Government have control over the 
pricing of drugs sold in the United States, let alone overseas. 
Marketing exclusivity through the use of patent laws in this country 
has been an important stimulus to the development of new products to 
treat a variety of diseases. The generic drug industry in the U.S. has 
also been efficient in producing generic versions of many important 
innovator drugs shortly aftre they have come off  patent. The patent 
on ddI expires on August 29, 2006.

I regret that this response could not be more helpful.

Sincerely
Dana Delman
Policy Analyst
FDA Executive Secretariat



-- 
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org