Federal action needed on drug shortages

A life-threatening crisis was averted this week when federal regulators approved foreign suppliers for two cancer drugs in dangerously short supply. But with the number of critical drug shortages soaring, Tuesday's action is a limited fix for a problem that demands a long-term solution from Congress.

This time it was methotrexate, used to treat childhood leukemia, and Doxil, used for ovarian cancer and AIDS-related Kaposi's sarcoma, that were in short supply. The Food and Drug Administration said Tuesday it will temporarily allow importation of methotrexate from Australia and a replacement for Doxil from India. Otherwise, patients could have begun missing treatments by the end of the month.

But there were a record 267 drug shortages reported in 2011. Most were generic injectables administered in hospitals and not very lucrative for drugmakers. Many are made by only one or two companies, so production disruptions can quickly pinch supply. Manufacturers are urged to voluntarily alert officials when they anticipate shortages, and an executive order from President Barack Obama in October gave the FDA some additional powers to address the problem.

But legislation that would require drugmakers to report impending shortages is languishing in Congress. So is action to relieve the years-long backlog of generic drugs awaiting FDA approval. The generic drug industry has proposed paying new fees to cover the cost of adding staff to speed FDA review.

Congress must not dally. There are lives at stake.