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Consulting

 

 

Patent and Generic Medicine Rules to be Proposed by President Bush.

 In a formal ceremony in the Rose Garden on Oct. 22, 2002 President Bush announced a plan that is designed to cut the cost of prescription drugs for all Americans, particularly Seniors.

 The plan, which could take effect in the next few months, is expected to save Americans up to $3 billion a year on their current prescription drug expenditure.

 

The new rules to be proposed by the President are based on a new interpretation of a law that controls how the brand name pharmaceutical companies get and preserve patents for the therapies they develop. This plan is reported to be in response to recent criticisms on how the industry allegedly exploits loopholes in the law to slow down generic competition and keep their brand name product on the market longer.

 

In the briefing session the White House stated that the proposal will have three parts. Section one addresses the issue of repeated 30 day stays by brand-name companies.  Bush proposes that a brand-name company be given only one such stay, to give the FDA time to determine whether-or-not to allow the generic on the market.  Secondly the plan would make it more difficult for companies to file “frivolous” new patents on their drugs; such as, new packaging, different ingredients added, or different forms of the same drug.  At the same time the White House does not want to hinder companies from getting patents for new uses of a drug; stating that they do not want to prevent research on beneficial new therapies.  Last, companies will be required to list more detailed information on their patent applications and certify that it is true.

 

The plan coming from President Bush will be detailed in a proposed FDA Regulation to be made public this week.  The FDA will invite responses to the regulation for 60 days.  The White House hopes to put the changes into effect soon thereafter.