E-drug: FDA analyst Dana Delman's insulting letter on ddI to Thai NGOs
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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
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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 after 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
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