WSJ - FDA Sets New Rules to Better Address Drug Shortages

The Food and Drug Administration has forged plans to deal with the thorny medical issue of drug shortages, especially for sterile injectable drugs like those used in emergency medicine, cancer and intravenous nutrition.

Under a new rule, the FDA will require companies to notify the agency of any plans to stop making drugs that are in short supply, or of any temporary manufacturing stoppages that would threaten supply. For the first time, the FDA will also apply these requirements to complex "biologic" drugs that are manufactured in microorganisms, plant cells and animal cells.

The FDA will take these actions through a new federal rule, and a strategic plan on drug shortages, both of which will be disclosed on Thursday. They put new teeth into a law passed by Congress in 2012 and an order signed by President Barack Obama in 2011.

Many drugs are in chronic short supply, and production snafus can create other shortages.

"Drug shortages are complex, and this isn't something that will be resolved overnight," said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "But we can find workarounds when there are other manufacturers" to make a drug in short supply.

The federal agency has already made some progress on the drug-shortage front, with more companies alerting it to coming shortages so that it can proactively find substitute manufacturers. Following the 2011 presidential order, the number of notifications by companies alerting the FDA of impending production stoppages has increased six fold. The agency said, too, that it has helped prevent 195 drug shortages in 2011 and 282 in 2012.
But this accomplishment falls far short of resolving the problem, according to doctors and researchers.
"The number of new drug shortages is declining, and that's good news," said Erin R. Fox, manager of the Drug Information Service at the University of Utah. "But the ones we have already are not going away. The current status is we're really stuck, and it's almost getting worse."

Among those drugs in shortest supply, she said, are electrolytes, vitamins and fluids used in resuscitation and in treatment of premature infants. "Patients are going without therapy," said Dr. Fox, describing the situation as "incredibly critical." She said the problem stems from the fact that there are only a handful of companies making mostly generic versions of the products in question. From time to time, these companies have closed down some of their production because of impurities such as glass or metal found in injectable products.

Intravenous drugs for cancer, including liquid nutrition for patients unable to eat and drink by mouth, also are in short supply.

Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology, said there have been shortages of mostly generic cancer drugs such as leucovorin, daunorubicin and cytarabine.
"None of this has really gotten better," said Dr. Schilsky. "It's hard to say what the FDA can do except use discretion in their regulatory oversight, and work with suppliers to assure adequate raw material supply."

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