Generic drug approval process streamlined

Medical societies and health activists hope the new rule means better availability of more affordable medications.

By Victoria Stagg Elliott, AMNews staff. Sept. 1, 2003.

This month marks an important change in the regulatory climate surrounding generic drugs.

The Food and Drug Administration will start implementing its final rule governing the speed at which generic drugs can move into the marketplace. The rule aims to speed consumers' access to generic drugs and reduce the number of barriers to their approval. It limits to one the number of automatic 30-month patent infringement stays that a drug company can file in order to delay a generic drug's entry.

Also, a company can only make a new patent claim on an existing name-brand medication on the basis of actual changes in the drug's active ingredient, formulation, composition and delivery method -- not in an effort to simply block a competing generic drug from getting the FDA's nod.

The agency hopes that this step will reduce the number of patent claims that do more to extend market protection of a name-brand drug than to document a true innovation.

"The final rule balances innovator drug companies' need for intellectual property protections and the desire to have equivalent generic drugs approved and marketed," according to an FDA statement. "[This] will help speed the approval of generic drugs and should result in billions of dollars in health care savings for consumers."