generic production of ciprofloxacin
Posted by Nader / Love on October 19, 2001 at 13:14:51:
October 18, 2001


Tommy G. Thompson
Secretary of Health and Human Services
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201


Dear Secretary Thompson:


We were shocked by your comments in the October 17, 2001 Washington
Post, indicating that you do not have the legal authority to authorize
generic production of ciprofloxacin, a drug used to treat victims of an
anthrax attack. This, of course, is not true. As your own staff is well
aware, you may use 28 USC 1498 to issue compulsory licenses for patents,
and you could immediately authorize the five companies who have already
satisfied US FDA requirements for the quality of their products to speed
the manufacturer of ciprofloxacin, and indeed this could and should be
done for any other medicine needed to confront the current crisis.


By failing to act, you are putting Americans at risk. By acting to
authorize generic competitors to manufacture ciprofloxacin, you would
reduce public anxiety over the supply of the drug, and take steps to
introduce competition which would ensure redundant capacity and a more
favorable procurement environment.


It is our understanding that public health authorities are seeking a
stockpile of 1.2 billion pills in order to ensure that there are
treatments for 10 million Americans. It is obvious that the fastest and
most efficient way to accomplish this is to authorize every qualified
pharmaceutical company who can supply the drug to do so. Anything short
of this is cutting corners. Why put the lives of millions of Americans
ar risk?


Americans are facing a public health crisis that demands leadership and
action. It is unacceptable, in the face of a biological assault against
US citizens, to fail to secure adequate supplies of medicines in the
event that anthrax exposure spreads. Moreover, you may soon find we
confront a different access problem for another medicine, in the face of
a different biological or chemical threat. You need to ensure that there
are systems in place to protect the public health, and you must use
every necessary mechanism to ensure an adequate, affordable supply of
medicines.


Under 28 USC 1498 it is clear. You can authorize immediately the
production of needed medicines. As you and your staff know, the US
government has used 28 USC 1498 in many cases for less serious matters,
to authorize contractors to use patents held by others in order to
provide goods and services for the government. This includes cases
involving pharmaceutical products, in far less difficult circumstances.


Bayer, the giant German pharmaceutical firm, currently markets
ciprofloxacin on an exclusive basis in the United States. Drug stores
are charging in some cases more than $700 for a two month's supply of
medicine that can be obtained for as little as $20 in some foreign
county generic markets, and now it seeks to be the exclusive company
that can supply 1.2 billion pills to the federal government. Bayer
stands to make hundreds of millions if not billions of dollars in the
wake of the September 11 terrorist attack on Americans.


In the absence of adequate government stockpiles, families who cannot
afford the hundreds of dollars per month per family member for
ciprofloxacin risk not having access to this product, should the need
arise. This is an unethical and unnecessary form of rationing. Some
government officials and those who can afford the high prices have
secure supplies of ciprofloxacin. It is your duty to see that all
taxpayers and especially those who are less affluent are protected, and
are protected as soon as is possible, not as soon as it is possible for
one firm, Bayer, to supply the market. And it would make sense to have
redundant sources of supply, for all of the obvious reasons.


More generally, you need to be forward looking, should other cases arise
with similar constraints on the access to medicines, and you need to
find ways to obtain whatever medicines may be needed. You need to
provide a framework for acquisition of needed medicines, including the
steps that will be taken to address issues of pricing and affordability.


In this review, you should examine US government obligations for
compensation under 28 USC 1498, to see if there is a need for statutory
changes that would ensure that firms cannot exploit the current
situation, or engage in bio-terrorism profiteering. In that respect, you
are urged to look at models such as those in HR 1708 which would give
the US government the same tools that most European countries have to
protect consumers from abusive prices, refusals to license technologies,
unreasonable restrictions on the use medical research tools, and other
areas of public interest.


Your official responsibility is to protect the public's health, and not
to defend large profiteering pharmaceutical companies, which are already
making a fortune because of our country's current problems. How do you
define the patriotic choice here?


Sincerely,


Ralph Nader


James Love



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