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Drug makers try to stall generics
March 17, 2008|Melissa Healy | Times Staff Writer
For the makers of brand-name prescription drugs, generic competition is about as welcome as a virus.
In the first year that a generic competitor goes on the market, a brand-name drug loses on average more than half of its market share, and its price drops with each new generic company that produces a copycat, May 2005 study said.

So companies that are about to face that competition have big incentives to delay the entry of new generics to the market -- and to erect obstacles to switching to the cheaper upstarts. Even a few months' delay in a generic's entry can salvage billions in revenue for the makers of a blockbuster pioneer drug.
The makers of brand-name pharmaceuticals also have powerful levers to maintain their exclusive hold on the market for their drug, or to staunch the loss of customers. They can slow FDA approval of a generic by filing "citizens' petitions." And they can lobby for state laws that would forbid switching patients from a brand-name drug to a generic without, say, the express approval of the prescribing doctor.
Citizens' petitions were designed to allow the public -- including consumers and watchdog groups -- to question the bioequivalence of a proposed generic or dispute a generic firm's capacity or legal right to produce a copycat drug. When filed, a citizens' petition triggers an obligatory FDA review of the issues raised -- a process that can delay a generic's approval by months or even years.
Citizens' petitions are now overwhelmingly filed by or on behalf of brand-name companies, and the FDA dismisses about three-quarters of them as without merit, says Kathleen Jaeger of the Generic Pharmaceutical Assn.
In addition to causing delay, these petitions often aim to cast suspicion among the public about a generic's effectiveness.