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