[Ip-health] Reuters on Schumer push for generic Cipro

[James Love]

The reporting is not that clear on this, but Schumer's request to DHHS
is I believe under 28 USC 1498.  Jamie

NY Senator urges U.S. to purchase generic Cipro
 
Updated: Tue, Oct 16 7:15 PM EDT 
 

WASHINGTON (Reuters) - A U.S. senator Tuesday called on the government
to increase the supply of the antibiotic Cipro, the only approved oral
treatment for anthrax, by purchasing cheaper generic versions of the
drug.

Sen. Charles Schumer, a Democrat from New York, said U.S. law allows the
government to make purchases from manufacturers other than the patent
holder, in this case Bayer AG.

"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," Schumer told a press conference.

Schumer and Sen. John McCain, Republican of Arizona, have introduced a
bill in Congress to limit the amount of patents that can be placed over
a branded drug, which would allow quicker introduction of cheaper
copycat drugs.

Germany's Bayer has said it plans to boost production of Cipro in
response to the increased demand that has followed the rash of U.S.
anthrax cases that began in Florida this month.

Bayer holds patent protection over sale of the drug in the United
States, and is slated to lose market exclusivity in December 2003.

The U.S. government has enough Cipro to treat 2 million people for 60
days but has announced it would like to increase that by 10 million.

In a conference call late Tuesday, Bayer officials refused to comment on
Schumer's proposal, but said the firm plans to boost production to 200
million Cipro tablets during the next three months, enough to treat
about 1.7 million people with the normal regimen of two pills per day.
It currently makes about 60 million tablets every three months.

Bayer officials said Cipro prices would remain at levels before the
Sept. 11 attacks. The average wholesale price is $4.67 per 500 milligram
tablet. It charges the government about $1.89 per tablet.

Schumer said he has been in contact with three generic drugmakers. Teva
Pharmaceutical Industries Ltd of Israel, Barr Laboratories Inc. in the
United States, and Ranbaxy Laboratories Ltd. in India, are willing and
ready to produce large shipments of generic versions of the drug if they
get a green light from U.S. regulators, he said.

Barr had challenged Bayer's patent on Cipro, but instead of pursuing the
matter in a potentially lengthy court battle, the Pomona, New York-based
company reached a pact with Bayer in 1997 to shelve the patent
challenge.

Under the terms of Barr's deal with Bayer, Barr received an initial
payment of about $25 million and gets royalty payments each quarter.
U.S. regulators are currently investigating whether big drug companies
violate antitrust laws with deals that keep generic versions of drugs
off the market.

"Our position at this point is we are ready, willing and able to make
the product," a Barr spokesperson told Reuters, adding that a few other
generic firms have tentative approval to market copycat forms of Cipro
once the patent expires.

Schumer called on the Department of Health and Human Services to sign
contracts directly with manufacturers to purchase the generic version of
Cipro in bulk quantities at significantly reduced prices.

A Food and Drug Administration spokesman said on Monday that the agency
believed Cipro supplies would remain adequate as long as people did not
hoard the medicine. "We believe there is an adequate supply," he said.

But Schumer said it was illogical to put the best U.S. response to
anthrax into the hand of one manufacturer.

"The fact is simple: there are other companies out there that can
produce the drug and we should ask them to do it," he said. "The plan
I've outlined would allow the government to stockpile generic versions
of Cipro while allowing Bayer to continue exclusive commercial
production."

Schumer's call comes one day Indian drug maker Cipla Ltd. offered to
supply large quantities of Cipro to the United States as further cases
of exposure to the bacteria emerged there.

Bayer said it plans to hold a conference call later Tuesday afternoon.
Further details were not immediately available.