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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.

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.
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.”

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.”