UPDATED: FDA planning new attack on drug shortages

There are 29 drugs on the FDA's most recent list of resolved drug shortages. The problem is, there are dozens and dozens more on the list of drugs still in short supply. The FDA has been having success in heading off new shortages, but the list of those hard to come by remains stubbornly persistent. The agency today announced two steps it hopes will help provide some relief.

"The number of new drug shortages is declining, and that's good news," Erin Fox tells The Wall Street Journal. "But the ones we have already are not going away. The current status is we're really stuck, and it's almost getting worse."

Fox is manager of the Drug Information Service at the University of Utah, which tracks shortages. She said right now the biggest problem seems to be with electrolytes, vitamins and fluids used in resuscitation and in treatment of premature infants. But there also are shortages of cancer drugs, and there are long lists of other needed treatments. Particularly troubled by shortages of drugs for children, 14 members of Congress in May sent a letter to the FDA urging it to do whatever is possible to solve drug shortages for pediatric drugs.

According to the FDA announcement, it has a new strategic plan, sent to Congress today, that looks short-term to improving its response to shortages and long-term to manufacturing quality imrovements that will prevent them. Secondly, it is proposing a new rule requiring manufacturers to include biologic drugs among those they must notify the agency about if they anticipate a shortage. It's unclear what result this new rule may have since many drugmakers already let the FDA know about any drug they believe will fall into short supply so the agency can look for alternatives.

The FDA has been putting big resources behind its efforts. Valerie Jensen, the FDA's associate director of drug shortages, in June said the agency has 25 employees working on each of the 133 medication shortages the FDA had listed at the time. There were 10 cancer drugs on the list, and she said the FDA expected to resolve those shortages soon. But when one gets resolved, another may come up.

In one case, that illustrates the difficulty of resolving shortages. Johnson & Johnson's ($JNJ) popular ovarian cancer drug Doxil went into shortage two years ago when the FDA took actions over shortcomings at the Boehringer Ingelheim plant that manufactured it for J&J. The agency worked with J&J on a new supply scheme to help resolve the shortage. It also allowed India's Sun Pharmaceutical Industries to import a generic that was unapproved in the U.S. It then put the Sun drug through an expedited review to get an approved version quickly to the market. The shortages of Doxil eased for awhile. But now that Boehringer Ingelheim has decided close the plant, J&J says Doxil will again be in short supply at least until late 2014 while it gets new suppliers approved. The Sun drug is available, and the company says it expects to be able to meet demand.

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

But Richard Schilsky, chief medical officer of the American Society of Clinical Oncology (ASCO), is less sanguine. "None of this has really gotten better," Dr. Schilsky said. "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."

- here's the FDA announcement
- here's the FDA plan 
- read the Wall Street Journal piece (sub. req.)

Related Articles:
Federal case over drug shortage comes to an end
J&J's Doxil shortage to last until at least end of 2014
Boehringer Ingelheim gives up on troubled Ben Venue plant, laying off 1,100
FDA close to resolving all cancer drug shortages
Pediatric drug shortages draw Congressional attention
FDA turns to Fresenius to help relieve TPN shortage

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