So :::: Hop in Granny's Time Machine
And ::: See Government in Action

India Offers $1 Million in Cipro Free ::: But :::
T. Thompson "pays it forward" to the Drug Mfgs


Published on Friday, October 26, 2001 by | Workingfor Change

Letter to Health and Human Services Sec. Tommy Thompson
by Laura Flanders

Dear Mr. Secretary,

Congratulations on your deal with the Bayer Corporation of Germany. The newspapers all seem very excited. You got Bayer to give you a cut price on their famous anti-anthrax drug, Cipro. Bayer has agreed to sell the administration 100 million tablets at 95 cents a piece, instead of their usual $4.67 a pill. Congress will only be paying Bayer $95 million, instead of almost half a billion dollars. That's great!

I did have one question. It's about India. Last week, the government of India offered to give the United States $1 million worth of generic Cipro as a gift to help us with the anthrax scare. That would buy some 10 million tablets in India, where Ranbaxy Pharmaceuticals sells their version of the same antibiotic for around 10 cents a pill. Ten million tablets could treat more than 833,000 people absolutely free! Wouldn't that be helpful?

The Indian government's offer did not receive much media attention even though it ran on several news wires, but I urge you to track down India's External Affairs Minister Jaswant Singh and take him up on his offer on our behalf.

Under your deal, Bayer cut the price of Cipro for the government, but it hasn't cut the price for private citizens who might need to buy some down the road.

I know, I know, nobody should be taking Cipro -- or ciprofloxacin, as it is called when Bayer doesn't make it -- unless they have good reason to believe they may have been exposed. But you've said the United States needs enough medicine to treat some 10 million people if the threat worsens -- and that probably doesn't even count folks, like the governor of New York, who misguidedly take it "just to be sure."

The usual treatment requires 120 pills per person; that's 1.2 billion pills. That's a lot of Cipro, and it's unclear if Bayer can even produce that much in a short time. In fact, it seems you are already dealing with shortages, if the government's recent response to events is any clue.

When those two postal workers died of anthrax after handling Senator Daschle's mail, a whole lot of government employees had good reason to get frightened. I know there are various drugs available to treat some kinds of anthrax, but the government chose Cipro to give to postal workers, and gave some out free of charge. Good for you.

We're still a bit concerned. The postal workers in Washington were given only ten days worth of Cipro. Your colleagues on Capitol Hill were given a sixty-day supply. Is that because there are shortages of Cipro, Mr. Secretary? If Cipro's the drug you think is best in these circumstances, wouldn't it be great to have a cheaper supply -- and a whole lot of free pills -- for those who are at risk, so that everyone who needs it could get the same professionally-approved standard dose?

If we bought the pills from India, we'd only pay $20 to treat a person with a complete ciprofloxacin therapy. The government could get the same number of pills they're getting from Bayer at one-tenth of the price, and could even resell to citizens who would otherwise have to pay 28 times as much. The Bush administration's always telling us that government should be frugal, and our national budget is suddenly bleeding red ink. Don't savings like these make sense?

Besides, Mr. Thompson, from what you've said in the past about welfare, I know you are a big believer in competition and the free market. You said women who'd been receiving welfare in your home state of Wisconsin were getting soft because of too much government aid.

Bayer owns the patent on Cipro until 2003 (a drug, by the way that was pushed through the FDA by government studies and the military's endorsement), and that that patent protects their monopoly in the U.S. market. But in this emergency situation, I think Bayer should have to compete -- just like those Wisconsin women had to! -- Even with firms in India, who can produce the same product more cheaply, and get it to us fast.

We're pretty scared out here, Mr. Secretary, and we care a lot more about protecting people than corporate patents right now. Don't you?

Laura Flanders is a journalist and broadcaster, host of the Laura Flanders Show (formerly on KWAB/RadioForChange) and author of "Real Majority, Media Minority: The Cost of Sidelining Women in Reporting." Her Spin Doctor Laura columns appear daily on WorkingForChange. You can contact her at laura@lauraflanders.com

© 2001 workingforchange.com


And ::: There is Much More
Schumer and McCain are Trying

"We cannot just rely on Bayer to ensure we have a sufficient supply of Cipro," Schumer said. "First, Bayer can only produce so much Cipro, and we should not put our best response to anthrax in the hands of just one manufacturer. Second, buying Cipro only from Bayer - who charges a lot more than generic manufacturers would - means we spend a lot more and receive a lot less. Hopefully, we won't even need to use the Cipro we already have on hand, but if we make arrangements to purchase it from multiple generic drug manufacturers, we'll have it if we need it."

Schumer also called on the Food and Drug Administration (FDA) to grant final approval to the five generic drug manufacturers who already hold tentative approvals to manufacture ciprofloxacin. Any manufacturer seeking approval solely to sell its product to the United States government can file a "paragraph IV certification" and receive clearance to begin production immediately. Denying certification could delay availability by at least 60-90 days, and since generic production of the drug will take an estimated 60-90 days before it becomes available, additional supplies of ciprofloxacin could be unavailable until April, 2002.

Schumer said that in order for any of the generic manufacturers to reach agreements with HHS, the United States would have to agree not to seek indemnification from the generic drug manufacturers if Bayer successfully sued, and would also have to agree to indemnify the manufacturers in the event Bayer successfully sued them for patent infringement. Federal law permits the United States to purchase products from manufacturers other than the patent holder, but says that the government could be liable for the patent holder's recovery of "reasonable and entire compensation for such use and manufacture." 28 U.S.C. 1498. No injunction preventing the generic manufacturers from producing ciprofloxacin and selling it to the government is available under 1498.

"Although it seems unlikely that Bayer would sue to prevent the United States from obtaining Cipro," Schumer said, "if that happens, the generic manufacturers need to be protected. Otherwise, they can't sell Cipro to the government and that puts us back to square one."

Although Bayer is the single patent holder for Cipro, the validity of its patent is in question. The Federal Trade Commission (FTC) is currently investigating possible anti-trust violations concerning a reported payment of over $200 million by Bayer to Barr Laboratories, the first generic drug manufacturer of ciprofloxacin to file with the FDA, to keep Barr's product off the market and avoid competing with Cipro. Bayer's payment to Barr prevents any and all generic drug manufacturers from producing ciprofloxacin until Bayer's patent expires more than two years from now.

Schumer is the author, along with Senator John McCain (R-AZ), of the Greater Access to Affordable Pharmaceuticals Act (GAAP), bipartisan legislation to improve access to generic drugs. The legislation would remove a number of obstacles currently blocking entry of many low-cost generic drugs to the market, including eliminating potential abuses of the 180-day exclusivity period granted to the first generic applicant, which has enabled Bayer to keep lower cost versions of ciprofloxacin off the market. The bill makes the exclusivity period available to the next-filed applicant if the first applicant has reached a financial settlement with the brand-name to stay out of the market until the patents have expired, fails to go to market within 90 days once their application is effective, does not get FDA approval within 30 months, fails to challenge a new patent within 60 days, withdraws their application, or is determined by the HHS Secretary to have engaged in anti-competitive activities.




- posted by JT @ 2:43 PM |