Until Midnight to Undo a Veto : Bush Administration misreads a very good orphan drug bill

The White House made a big mistake Friday on a bill intended to trim huge profits from some drugs that are produced under federal protection to treat rare diseases. It should erase the error.

The mistake was an announcement that President Bush would let the bill die. That baffled Washington, where decisions often hinge on relative levels of pain inflicted by lobbyists. This bill was painless.

The Senate and the House approved the bill unanimously. The pharmaceutical industry was prepared to step aside and let the bill become law.

The bill amends the Orphan Drug Act of 1983, so-called because drugs useful only for treating very small numbers of patients seldom cover the cost of research and so were left out in the cold.

The act gives manufacturers a seven-year monopoly on sales, plus tax incentives, for developing drugs for patient-populations of under 200,000. The industry has responded with 49 new drugs so far.

Nobody questions the good it has done, only the occasional side effect. For example, one drug, used to treat a kidney ailment, earned $200 million in its first year, not exactly the minuscule market Congress had in mind in 1983.

The new bill would move a drug out of the orphan category if the number of patients being treated with it went over 200,000, and would let rival drug firms produce the same drug if they applied for market protection within a year of one another.

The National Organization for Rare Disorders first opposed the bill but now supports it. Executive Director Abbey Meyers said she thinks Bush does not understand the problem.

That seems likely. The White House said that cutting off exclusive marketing rights, when some 200,000 patients needed a drug, would weaken research incentives.

But the number of patients with rare diseases is static, except for AIDS, and that is why drug companies stayed out of the market for so long.

The President has until midnight to rethink this. He would be wise to do so.