THE PRESIDENT’S DRUG PLAN

President Bush’s welcome announcement this week to reduce through rule-making the delay of bringing generic drugs to market should help a little, but it also forcefully points to the need for further legislation. The House’s lame-duck session is the appropriate time to do this and a bill already passed in the Senate is the proper proposal.

The president’s bill does some of what is accomplished in the bill by Sen. Susan Collins and Sen. John Edwards of North Carolina, but not nearly enough to fully close loopholes in drug-patent law and ensure prices for a broad range of drugs drop for consumers. For instance, the president’s plan does not give a generic-drug company the right to sue if it believed a patent-drug company was filing new patents solely to delay the generic equivalent of a drug.

These delays and others that endlessly extend drug patents cost consumers billions. The Bush administration estimates its plan would save $3 billion annually; the Edwards-Collins legislation, overwhelmingly endorsed by the Senate, would save far more. But even if it supported all of the measures in the Senate generics bill, which it does not, but the Bush administration could not make those extensive changes through rule-making.

That’s why the Edwards-Collins legislation is so necessary. It narrows the patent extension to a single 30-month stretch unless a judge specifically allows it to continue, lessens the possibility of paying a generic manufacturer to keep a drug off the market by limiting its exclusivity rights and reduces the incentive for brand-name drug manufacturers to file frivolous patents. The bill is fair to manufacturers and helpful for consumers, returning patents to the process envisioned when the drug-patent law under the Hatch-Waxman Act was passed a generation ago.

The president no doubt recognizes the interest this election season in doing something to lower the price of prescription drugs, saw the lack of movement on the issue in the House and saw an opportunity to offer a compromise that could take effect in a couple of months. His involvement is encouraging, although it should not tell House members that the issue is now finished. Instead, they should take the rule changes as evidence that there is broad agreement that action is needed.

The Maine Department of Human Services expects to save about $20 million in Medicaid funding this year by emphasizing the use of generic drugs, which typically cost half or less than their brand-name competitors. Without removing the incentive for drug manufacturers to continue research – the legislation leaves original patents alone – the bill delivers essential drugs at a much lower cost.

Having recognized both the problem and an opportunity for a solution, the White House could help Congress complete work on this bill next month.