Hill Action – New Proposed Legislation Affecting Generics

J0262969 The Los Angeles Times reports that new legislation has been introduced that would impact pharmaceutical practices regarding generics.  The Bill is S. 3695 introduced by Senators Rockefeller, Schumer and Leahy and aims to make an impact of the involvement of pharmaceuticals in the generics market.

The bill is very short.  It would prohibit a brand-name drug being manufactured by the company that had marketed it from converting it to a generic immediately after it loses patent protection.  These are called "authorized generics" and the bill would make them history. 

Under current practice, when a pharmaceutical brand drug goes off patent, the manufacturer can issue it as its own generic or license it to another.  As an incentive to generic manufacturers, they are given 180-day exclusivity when they challenge and win against a patent holder.  But the Senators who are proposing the legislation say that authorized generics cuts into this 180-day exclusivity of the new generic manufacturer. 

On the other hand, previous FDA studies have demonstrated that the more generics that are on the market, the faster the price decreases.  Some may wonder then, why the senators feel that fewer generics will accomplish the same.  It does not seem as if generic manufacturers have been unwilling to challenge patents, so one is left to wonder if there is a problem that is truly in need of fixing?    

There is a link to the legislation above.  In the future, I’ll list the legislation in the right hand column.  If you are interested, you can track it yourself at GovTrack.US

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