Thursday, May 24, 2012

A Newsday editorial on drug shortages

Congress should do its part to make sure fewer patients get the horrifying news that a drug needed to treat a life-threatening illness is simply not available.

There have been disruptive shortages of an alarming number of drugs in recent years, particularly sterile injectables used in hospitals to treat conditions like cancer and systemic infections. The number tripled over the last six years, and hit a record of 267 in 2011. The American Medical Association has called the situation a public health emergency.

Under an executive order issued in November, the Food and Drug Administration asked drugmakers to voluntarily report production disruptions. The result has been a sixfold increase in notifications and fewer shortages -- 42 new ones this year compared to 90 at this time last year.

Legislation slated for a Senate vote this week would help sustain the gains by turning that request into a requirement. It would mandate that companies alert the FDA of production problems up to six months before they result in a shortage. Congress should also impose fines for noncompliance to prevent lax reporting once the crisis ebbs. Currently only companies that are the sole source of a drug considered indispensable are required to give advance notice before shutting down production.

Shortages often occur as a result of quality-control problems in production facilities or disruptions in the supply of ingredients. Most of the drugs involved are generics that aren't particularly profitable. Many are made by only one or two companies, so production troubles in a single plant can dramatically pinch the supply.

The Senate bill would also allow the FDA to expedite the inspection and approval of new manufacturing facilities, which should help.

With early warning, the FDA has shown that effective action is possible. Alerted in February that metho-trexate, used to treat childhood leukemia, and Doxil, used for ovarian cancer and AIDS-related Karposi's sarcoma, were in short supply, officials temporarily allowed importation of methotrexate from Australia and a replacement for Doxil from India.

The Senate, and then the House, should give this critical early warning system some legal muscle.

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