[Ip-health] Schumer's Press Release on CL for Cipro

[Mike Palmedo]

http://www.senate.gov/~schumer/

SCHUMER: NEW CIPRO SOURCE COULD DRAMATICALLY INCREASE SUPPLY

October 16, 2001

Washington, DC -- US Senator Charles E. Schumer today said that the
United States could significantly increase its supply of Cipro by
purchasing the drug's generic version directly from manufacturers.
Schumer called on the US Department of Health and Human Services (HHS)
to sign contracts directly with manufacturers to purchase the generic
version of ciprofloxacin in bulk quantities at significantly reduced
prices, increasing the drug's supply while decreasing its cost to the
government. 

Bayer holds the patent for Cipro – the brand name version of
ciprofloxacin, the most effective drug for treating anthrax – until
December, 2003. However, Bayer's ability to produce sufficient amounts
of Cipro is questionable and, as the drug's sole patent holder, Bayer
charges approximately 50% more than what the generic version is likely
to cost. Federal law – 28 U.S.C. §1498 – allows the United States to
purchase products like ciprofloxacin for official use from manufacturers
other than the patent holder. 

<snip>

HHS Secretary Tommy Thompson has requested an additional $643 million to
purchase antibiotics including Cipro, but that would only cover the
treatment of an additional 1.5 million people for sixty days. As the
sole patent holder, Bayer can set the price for Cipro and latest reports
indicate the price has risen significantly above the $3.20 per pill
level. – approaching $400 per patient in total . Patients using Cipro
take two pills per day for sixty days. On average, generic drugs cost
approximately 50% less than the brand name prescription version,
allowing the United States to obtain more than double the current amount
available with the funds Thompson has requested. 

<snip>

"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. 

<snip>