Regulatory Focus™ > News Articles > FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages

FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages

Posted 11 February 2013 | By Alexander Gaffney, RAC

It's been more than a year since the US Food and Drug Administration (FDA) started to make a concerted, large-scale and coordinated effort to combat mounting drug shortages. But now, in response to new statutory requirements contained within the FDA Safety and Innovation Act (FDASIA), the agency is reaching out to the public in the hopes of learning what more it might be able to do.


The US has been grappling with a series of mounting drug shortages for the better part of two years. Though the causes are legion-quality failures, reimbursement problems, low profit margins, lack of consumer appreciation for quality, rampant sterility issues, gray market pharmacies and everything in between-the effects of the shortages have been simple: Consumers can't get the medication they need, sometimes to survive.

The shortages have largely affected sterile injectable drugs, many of which are used in the treatment of cancer. Two drugs in particular, Doxil and methotrexate, are so widely used and were in such shortage that FDA resorted to allowing the selected import of otherwise unapproved drug analogs to reduce shortages (Lipodox from India's Sun Pharma and methotrexate from Hospira's Canadian supplier).

With so many causes, FDA has cautioned that drug shortages are likely to be persistent for years, even with sustained FDA efforts to reduce them. One of the biggest challenges noted by FDA's Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research, is that facility upgrades to alleviate systemic shortages will take time. "It will be several years before companies building new plants get them up and running," she said in March 2012. "We don't have any expectation the issue will be resolved soon."

That's because if a facility has endemic problems, it likely needs extensive-and costly-renovations, the likes of which were recently seen at Ben Venue's Bedford, OH manufacturing facility, which has undergone $300 million in renovations in order to resume operations after quality deficiencies forced it to shut down.

But even if those shortages take years to fully resolve, FDA isn't exactly resting on its haunches and waiting for it to happen naturally. 2012 saw a flurry of regulatory activity by the agency, undoubtedly eager to remove itself from the crosshairs of angry legislators, some of whom directly blamed the agency's regulatory enforcement actions for the shortages. Its actions-better communication, use of regulatory enforcement discretion, new guidance documents, new directives and more-have resulted in improvements.

In September 2012, NBC reported that drug shortages are down by about a third relative to 2011, which saw 267 drug shortages. At least 52 of those drugs are no longer in short supply, the report found.

A Strategic Plan

But past, as they say, is prologue, and FDA is now in the process of getting together additional plans that legislators hope will allow it to resolve shortages more quickly and fully.

In a Federal Register notice posted on 11 February 2013, FDA notes that it's looking for assistance, which will be used to help draft a "Strategic plan on drug shortages," as required FDASIA's Title X, "Drug Shortages."

"As soon as practicable after the date of enactment of FDASIA, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages," Section 506D of the Act says.

That strategic plan is to include ways to "improve interagency and intra-agency coordination, communication and decision making," and mandates that FDA consider the possibility of drug shortages when conducting any regulatory action against a manufacturer. The effects of drug shortages on clinical trials, the possibility of establishing a "qualified manufacturing partner program," and communication plans will also be considered.

Such a "qualified manufacturing partner program" would potentially allow a third-party manufacturer to produce drugs in short supply so long as they have the "capability and capacity" to supply those products. FDA is also set to examine whether incentives are necessary to allow qualified manufacturers to participate in the program.

A similar model was recently used on a novel, one-off basis by Ben Venue, which manufactures a large number of drugs, including Johnson & Johnson's Doxil (doxorubicin). Under the plan, Ben Venue would manufacture the drug products, which would then be testing and finishing the product to ensure its sterility. Under normal circumstances, regulations require quality to be built into the process, not tested.

Other Questions

But beyond the questions prescribed by FDASIA, FDA said it has a number of questions of its own that it wants answers to, including:

  • What metrics do manufacturers currently use to monitor production quality? 
  • To what extent do purchasers and prescribers use information about manufacturing quality when deciding how to purchase or utilize products? 
  • What kinds of manufacturing quality metrics might be valuable for purchasers and prescribers when determining which manufacturers to purchase from or which manufacturers' products to prescribe?
  • What kinds of manufacturing quality metrics might be valuable for manufacturers when choosing a contract manufacturer? 
  • How frequently would such metrics need to be updated to be meaningful?
  • Is it possible to design a qualified manufacturing partner program-similar to that used by the Biomedical Advanced Research and Development Authority (BARDA)-that would have a positive impact on shortages?
  • Are there incentives that FDA can provide to encourage manufacturers to establish and maintain high-quality manufacturing practices, to develop redundancy in manufacturing operations, to expand capacity, and/or to create other conditions to prevent or mitigate shortages?
  • Are there incentives other US government agencies can provide, separately or in partnership with FDA, to prevent shortages?
  • Are there changes to existing drug shortage monitoring and mitigation tools that FDA can make to improve their utility in managing shortages? 
  • Are there other actions that FDA can take under its existing authority to address impending shortages?
  • Are there other communication tools that FDA should use or additional information the Agency should share to help health care professionals, manufacturers, distributors, patients, and others manage shortages more effectively? 
  • Are there changes to our public shortage Web sites that would help enhance their utility for patients, prescribers, and others in managing shortages? 
  • What impact do drug and biological product shortages have on research and clinical trials?  What actions can FDA take to mitigate any negative impact of shortages on research and clinical trials?
  • What other actions or activities should FDA consider including in the strategic plan to help prevent or mitigate shortages?

Comments on the strategic plan proposal are due by 11 March 2013.

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