Generic-Drug Industry Sues U.S.Over New Pediatric-Drug Policy

[James Love <love@cptech.org>]

At the end of this story, the average cost of pediatric clinical trials is put
at $250,000 to $1 million.
jamie

-------------------------
February 23, 1999

Generic-Drug Industry Sues U.S.
Over New Pediatric-Drug Policy

By ROCHELLE SHARPE 
Staff Reporter of THE WALL STREET JOURNAL

WASHINGTON -- The generic-drug industry has sued the U.S. 
government over its new pediatric-drug rules, saying they 
allow major pharmaceutical firms to get unfair patent and 
market-exclusivity extensions on blockbuster
medicines.

  [snip]

So far, drug companies have received six-month 
market-exclusivity extensions for various versions of five 
products, including Zantac, Advil and Motrin, reaping millions 
of dollars in extra profits by stalling off generic 
competitors. Six months of exclusivity on an average-selling 
drug is estimated to be worth $50 million, industry experts say.

The pediatric provisions, part of the Food and Drug 
Administration Modernization Act of 1997, give companies that 
study a drug's effect in children the right to keep generic 
versions of their product off the market for an extra six months 
-- either by extending the drug's patent or its market-exclusivity 
rights. Congress approved the law to encourage companies to test 
drugs' effects in children. With less than 20% of drugs approved 
and labeled for pediatric use, pediatricians are often forced to 
guess a drug's effect and what dosage level to prescribe.

'Interpretation Too Broad'

But the generic-drug groups contend that the FDA is interpreting 
the new law much too broadly, letting companies extend their 
marketing exclusivity on entire lines of products rather than on 
just the one drug studied for pediatric use.

For instance, Glaxo Wellcome Inc. now has market exclusivity 
on its popular Zantac products until June 1999 because it 
filed a study on pediatric use of an injectable form of Zantac for 
newborns on Dec. 18, 1998 -- one day before its
rights to exclusively market the over-the-counter versions of 
Zantac expired. The injectable form is useful for prematurely 
born babies that have partially formed digestive systems, while 
the over-the-counter drugs are used primarily for adults with 
ulcers.  Zantac had world-wide sales of $1.25 billion
last year, Glaxo Wellcome said.

    [snip]


"We went in knowing we were rewarding the drug companies too 
richly," said Timothy Westmoreland, spokesman for the Elizabeth 
Glaser Pediatric Aids Foundation, which had strongly supported 
pediatric testing of AIDS drugs. "But our past history shows that 
was the only way of motivating them."

The average drug company will probably spend $250,000 to $1 
million to do a pediatric clinical trial, he said, but will reap 
an extra $50 million in profit for its six-month 
marketing-exclusivity extension. But, he noted, drug companies
have ignored testing their products for pediatric safety for 35 
years.

    [snip]

-- 
James Love, Director, Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036, v202.387.8030 f202.234.5176
http://www.cptech.org, mailto:love@cptech.org