DOJ investigation of Tamoxifen prices

[James Love <love@cptech.org>]

Publication Date: Thursday December 31, 1998
  USA Today
  (Copyright 1998)
  By Jayne O'Donnell

   The Justice Department is investigating whether a deal between a 
generic-drug maker and the U.S. patent holder for the breast cancer 
drug
tamoxifen is keeping prices high. 

   Zeneca Pharmaceuticals settled a 1993 patent-infringement case 
against
generic-drug maker Barr Laboratories by paying Barr $21  million and
giving it
U.S. distribution rights to generic tamoxifen.

   With a patent, a pharmaceutical company has exclusive rights to a 
drug for
17 years. Zeneca, which has a patent on tamoxifen until  2002, sued
after Barr
applied to the Food and Drug Administration to  sell generic tamoxifen,
charging
that Zeneca's patent was invalid. 

   Investigators now are looking at whether the agreement hurt 
competition
because if Zeneca hadn't settled and its patent had been  declared
invalid,
other companies could have started selling  tamoxifen. 

   The average wholesale cost of a one-month supply of Nolvadex, the 
brand name
of tamoxifen, is $101.80, with retail pharmacy prices  ranging from
about $104
to more than $120. Although generic drugs  sometimes cost as little as
20% of
the price of the brand-name drug,  generic tamoxifen often sells for 95%
of
Nolvadex's cost. 

   "In normal cases, we always carry the generic," says Jerry Danoff, 
owner and
pharmacist at The Medicine Chest in McLean, Va. "But the  price is so
close, it
just wouldn't mean anything for the patient or  the insurance company." 

   In October, the FDA approved use of Nolvadex for women who are at 
high risk
for breast cancer. The drug was already the most-prescribed  hormonal
treatment
for breast cancer in the world. 

   Federal antitrust enforcers have been targeting patent litigation 
settlements that they think are anti-competitive. The Federal Trade 
Commission
is investigating a settlement last year between Hoechst  and Andrx.
Hoechst
agreed to pay Andrx $40 million a year not to sell  the generic version
of the
heart drug Cardizem until the companies'  patent litigation was settled. 

 [snip]