NCPA - National Center for Policy Analysis

Rules Changes Will Save $3.5 Billion

June 19, 2003

Cheaper generic drugs will get to market faster with Food and Drug Administration rules changes announced by President Bush last week.

The FDA rules complement broader reforms in Senate legislation that Bush had opposed until last October.

  • The rule change should save seniors money long before proposed prescription-drug Medicare benefits would be slated to take effect.
  • President Bush said the savings with the new FDA rules will run to $3.5 billion a year for consumers, and government and employer health plans.
  • Beginning in August, the rules will allow brand-name drug makers a single 30-month extension of their monopoly after suing a generic competitor for patent infringement.

The FDA also will limit generic-blocking over patents on features unrelated to drug effectiveness. That should curtail delays of generic competitors, which may now be sued and blocked from going to market for years by multiple patent disputes over issues as ridiculous as pill color.

The Senate legislation also will deter brand-name drug makers from another practice: paying generics companies to delay the introduction of cheaper competitive drugs.

Source: Editorial, "Drug Price Relief at Last," Miami Herald, June 19, 2003.


Browse more articles on Health Issues