Protect supply of cancer medications

If you or someone you love has a life-threatening illness, you don't want to hear the drugs you need aren't available. But that's increasingly what's happening. There have been critical shortages this year of a record number of prescription drugs used in treating cancer, serious infections and other illnesses.

Virtually all of the 820 hospitals the American Hospital Association surveyed nationally this summer experienced one or more drug shortages in the past six months, and a majority of them delayed treatment and rationed drugs as a result.

Officials of the Food and Drug Administration aren't sure why scarcities are increasing, but the number of drugs in short supply has tripled over the last six years, hitting a record 178 last year. With 180 shortages declared so far in 2011, another record is assured.

Most of the supply problems have involved "sterile injectables," medicines given by injection or intravenously to patients in hospitals. Supplies of the mostly generic drugs have been pinched for a variety of reasons, including quality control problems in some production facilities, disruptions in the supply of ingredients and, in some cases, increased demand.

Many of the drugs involved have been on the market for years and are no longer particularly profitable, so fewer companies are making them. That problem has been compounded by consolidation in the generic drug industry, where mergers and acquisitions have reduced the number of competitors. As a result, production problems in one or two plants can lead to significant supply disruptions.

The White House and Congress are considering creating a national stockpile of crucial cancer drugs or the active ingredients needed to make them. It's a promising approach already used with certain vaccines and antibiotics. With critical drugs it would have the added benefit of undermining unscrupulous wholesalers who buy up scarce drugs and sell them to hospitals at more than 10 times the usual price, exploiting shortages they helped to create. About half of 549 hospitals surveyed by the Institute for Safe Medication Practices this summer reported purchasing drugs from such gray market vendors in the past two years.

Congress should also require drug companies to alert the FDA if they become aware of potential production disruptions that could lead to shortages, while ensuring the alerts don't become shopping lists for gray market wholesalers. Right now, notification is voluntary with one exception: Companies that are the sole source of a drug considered medically necessary are legally required to notify officials six months in advance if they plan to shut down production.

With early warning, in cases with more than one supplier, the FDA has been able to work with other firms to ramp up production. In especially critical situations, if supply problems with an FDA-approved drug can't be resolved quickly, the agency has the discretion to allow the limited importation of a version of the drug from a reputable foreign manufacturer until the shortage is resolved. FDA officials said they helped head off shortages of 38 drugs last year.

Some in Congress won't like more regulation and greater government intrusion in the private market. But there are lives at stake. hN