THE HOUSE gave unanimous approval this week to a compromise worked out between the two major factions of the drug industry -- those that produce brand-name drugs and those that produce lower-cost generic copies. By happy circumstance, consumers will suffer no harmful side effects from the deal. In fact, they should benefit substantially.
For manufacturers of generics, the bill promises streamlined government clearance of copies of brand-name drugs whose patents have expired. Firms will no longer have to duplicate the expensive and time-consuming tests of drug effectiveness and safety -- a burden on both the firms and the government that had no justification beyond protecting brand-name drug manufacturers from unwanted competition. Generic makers would have to prove only that their copies are the chemical duplicates of previously approved drugs. This should mean much lower prices for the many widely used drugs no longer covered by patents.
The bill would give firms up to five years of added patent protection to compensate for marketing time lost because of government-required testing and review. It would also assure firms that generic-company challenges to their patents -- more likely under the new review system -- will not deprive them of at least a few years of protected marketing in which to recoup their investments. Brief protection would also be given to prescription drugs cleared for over-the-counter sales if the government required substantial new testing.
Some consumer advocates have attacked the new patent protections as excessive. But it's important to remember that neither the generic industry nor the consumer will benefit if major drug companies aren't willing to make the huge investments needed to develop, test and market new drugs. That's why the concessions included in the bill for brand-name manufacturers are also, ultimately, in the consumer's interest.
The Senate has already passed a bill differing in only minor respects from the House version, and the White House now supports both measures. The only roadblock is a protectionist textile labelling provision riding on the House version -- an issue that should not prevent Congress from completing work on the measure before it adjourns.