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CNN Live Event/Special

Senator Schumer Pushes for Production of Generic Cipro

Aired October 16, 2001 - 14:17   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
AARON BROWN, CNN ANCHOR: Senator Chuck Schumer is speaking on this very subject now -- on Cipro.

(JOINED IN PROGRESS)

SEN. CHARLES SCHUMER (D), NEW YORK: Everyone knows we need to be aware of the potential for a biological attack. And everyone knows we need to be ready. And most people are beginning to learn that the United States needs to increase its supply of Cipro, the drug used to treat anthrax. And people are learning that there are concerns as to whether Bayer, the company that makes Cipro, has the capacity to handle it.

Given the fact that there is now only one manufacturer, there is real concern that we have enough Cipro on hand to deal with any potential future crisis. Fortunately, there is a solution. I have learned that the United States could significantly increase its stockpile of Cipro, the most effective drug for treating anthrax, by purchasing a generic version of the drug directly from manufacturers.

A federal law, specifically 28 U.S. Code, Section 1498, allows the government to make these purchases from manufacturers other than the patent holder, which, in this case, is Bayer. So if we invoke this statute, we can greatly increase our supply of Cipro and greatly reduce the cost to the government by about 50 percent. If we increase the number of manufacturers, we're more likely to have enough on hand should we need it.

Knowing we have enough Cipro just in case would go a long way towards calming the public about potential shortages and hopefully dissuading people from buying, stockpiling and taking a drug they currently don't need.

So, today, I'm calling on the Department of HHS to sign contracts directly with manufacturers to purchase the generic version of Cipro in bulk quantities at significantly reduced prices. Let me emphasize that this is a step I believe we should take out of an excess of caution. The government currently has enough Cipro to treat at least -- approximately two million people for 60 days. That's the length of time generally necessary to treat anthrax.

Secretary Thompson has requested an additional $643 million to build our antibiotics stockpiles. If all this was spent on Cipro, it would cover an additional 1.5 million people for 60 days. If the government buys the generic drug from generic manufacturers, we will be able to stockpile twice as much Cipro at half the cost.

Bayer has announced it will begin increasing Cipro production by 25 percent. But its ability to produce sufficient Cipro beyond the additional 10 million treatments requested by the U.S. government is unclear.

I have spoken to three generic manufacturers who are willing and ready to begin production of the generic version of the drug. There are two more that may already produce it. Some of these have been given preliminary approval by the FDA. The companies, for your information, are among the largest generic producers: Teva Pharmaceuticals, Par Pharmaceuticals and Ranbaxy Pharmaceuticals.

And they have assured me -- I have spoken to the CEOs of each this morning -- that they could begin shipments of the drug in eight to 12 weeks. Collectively, they could produce as much as 50 to 60 million pills per month, enough to treat a million people per month, should we need it. Each of these companies holds tentative approval from the FDA to produce the generic Cipro. All they need is a government contract and a final go-ahead from the FDA.

While Bayer, the current single patent holder -- while Bayer is currently the single patent holder for Cipro, the validity of its patent is in question. And the FDC is in process of investigating antitrust violations by Bayer to keep the drug off the market. But the fact is simple: There are other companies out there that can produce the drug. And we should ask them to do it.

The plan I've outlined would allow the government to stockpile the generic version of Cipro, while allowing Bayer to continue exclusive commercial production, at least until the patent issues in question are resolved. From a broader perspective, it's illogical to put our best response to anthrax in the hands of just one manufacturer. And it's illogical to spend a lot more for the drug and receive many fewer doses. Hopefully, we won't even need to use the Cipro we already have in the stockpile. But if we make plans to purchase it from multiple generic drug manufactures, we'll have it if we need it.

That's the bottom line here. Let's take cautious, proactive steps now to avoid the potential -- and I repeat, "the potential" -- for a hastily responded -- a hastily-planned response to crisis later.

Questions.

Yes, Julie (ph).

QUESTION: (OFF-MIKE) tentative FDA approval. Does that mean that they are ready to go, but for this patent issue? Or are...

SCHUMER: Well, here's the basic lay of the land. The actual patent expires in 2003. Originally, one company, Barr Pharmaceutical (sic), challenged the patent. And it's been alleged that they paid, that Bayer paid Barr $200 million not to go forward. But there are others that are challenging the patent. The FTC is looking into this. It may be wrong for them to do. But, regardless, the law allows... (INTERRUPTED FOR LIVE EVENT)

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