WASHINGTON, June 12 (UPI) -- Health and Human Services Secretary Tommy Thompson Thursday announced new FDA rules to streamline the process for making generic drugs available.
The changes includes limiting drug companies to only one 30-month patent challenge "stay" of a generic drug's entry into the marketplace,
The FDA also will implement changes in its review process to help improve the speed and reduce the cost of determining a new generic drug is safe and effective.
Officials say the rules changes will save consumers about $35 billion over 10 years by making generic alternatives to certain more costly brand-name drugs available more quickly by avoiding legal delays.
The improvements in the efficiency of review procedures, which will require changes by both FDA and generic manufacturers, are expected to save consumers billions more by reducing the time for determining new generic drugs are safe and effective.
