Regulatory Focus™ > News Articles > Reasons for Shortage Unclear, House Members Ask FDA to Consider Importing Alternatives

Reasons for Shortage Unclear, House Members Ask FDA to Consider Importing Alternatives

Posted 14 November 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) may have recently unveiled a new rule intended to facilitate more coherent responses to ongoing drug shortages, but some legislators are now hunting for answers about one shortage of a drug used to treat childhood cancer patients, saying neither the agency nor the drug's manufacturer have been able to provide answers thus far.


As regular readers of Focus well know, drug shortages have been an endemic problem in the US for at least the last two years.

Causes of the shortages are myriad, including gray market pharmacies, government reimbursement policies, low profit margins for generic manufacturers, quality manufacturing problems, and allegations of overly aggressive inspections by FDA.

In response to these challenges, FDA has taken a number of actions intended to mitigate the effects of drug shortages over the course of the last year. Among them:

  • allowing the import of certain unapproved drugs to ease especially dire shortage situations
  • asking manufacturers to notify FDA of any impending supply problems or disruptions
  • working one-on-one with manufacturers experiencing problems
  • approving novel manufacturing agreements for some facilities to allow them to release some products for further processing or quality checks-a significant deviation from the usual quality-by-design parameters of current good manufacturing practices (CGMP)
  • expediting the reviews of substitute medications
  • formulating a strategic plan on drug shortages, as required by Title X, Section 506D of the Food and Drug Administration Safety and Innovation Act (FDASIA)

Most recently, FDA proposed a rule, Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products, requiring manufacturers to notify FDA of disruptions in their manufacturing processes.

FDASIA and Shortages

But perhaps the most visible way FDA has been fighting drug shortages has simply been to inform people that they exist. The information obtained by FDA has been going into an online drug shortages database, which indexes the drugs and provides information about the dose of the product, estimated date of availability, reason for the shortage and any other related information.

Under FDASIA, manufacturers are required to notify FDA of disruptions, and FDA is required to obtain the reason for the shortage from the manufacturer (Sec. 506E). And under the proposed regulation on drug shortages, manufacturers will be required to notify FDA of the reason for the discontinuance.

Meanwhile, though, the FDASIA legislation does not seem to contain any provisions requiring a drug company to make that information available to FDA.

House Members: Why the Shortage?

And the lack of information provided either to FDA or by FDA for some shortages has left some members of Congress frustrated.

In a letter this week to FDA Commissioner Margaret Hamburg and pharmaceutical manufacturer Teva, members of the Childhood Cancer Caucus expressed concern that supplies of daunorubicin, a drug used to treat leukemia in children, has been in short supply for months with no indication as to what is causing the shortages.

"The FDA website does not list a reason for the shortage, leaving providers little additional information to estimate the potential scope of the disruption," members of the caucus wrote on its website. The low supplies of the drug are reportedly causing disruptions in clinical trials, as some groups will not start a trial unless they already have a full course of the treatment on hand. Already, some children have been unable to enroll in one prominent trial, legislators wrote.

The drug's current listing (last updated 23 October 2013) on FDA's website lists the shortage reason for daunorubicin as "other."

"Teva has daunorubicin available on allocation with limited supply through 1Q 2014," announces another part of the notice.

Legislators say they're calling on FDA and Teva to inform them "as to the cause of this shortage and the plans in place to return daunorubicin to full production." In addition, legislators asked FDA if it had considered-as it did with doxirubicin last year-importing the drug from foreign sources if it remains in short supply domestically.

"We strongly urge you to do what you can to reduce or eliminate this critical shortage as soon as possible," wrote Michael McCail (R-TX) and Chris Van Hollen (D-MD), co-chairmen of the caucus.

Letter to FDA

Letter to Teva

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