Generic Drugs

Published January 1, 2003

The cost of that prescription drug you take may be going down soon.

The Bush administration announced new rules designed to speed up the process of getting generic drugs to market by limiting how many times the makers of brand-name drugs can request additional patent protection.

The change, effective on August 18, 2003, limits brand-name pharmaceutical companies to only one 30-month extension of a legal patent. Repeated extensions, while currently legal, delay the availability of a generic drug.

The Bush administration says the move could save consumers $35 billion over 10 years by making generic alternatives available sooner.

In addition, the FDA is planning to speed things up even more by cutting three months off its consideration period for a generic application. This is currently a 20-months-long process. Basically, the change means better advice to generic manufacturers on how to file a drug application properly.

But a nagging issue remains. The biggest problem in health care may be that a small percentage of the population consumes most of the nation’s health care dollars. We still have to address the fact that people don’t plan ahead for long-term health care insurance, as they do for homeowner’s and automobile insurance.

IT’S YOUR HEALTH is written by Conrad Meier, senior fellow in health policy at The Heartland Institute. This program is produced as a public service by Radio America. Meier passed away unexpectedly on March 18, 2005.