By Osefame Ewaleifoh (PhD/MPH candidate)
The problem of drug shortages remains a subtle but complex public health concern particularly for clinics in remote locations and surgical centers. Drug shortages stem from an intricate web of economic, legal, and clinical decisions that span from the need to tightly regulate the distribution of highly potent drugs to lack of infrastructure for delivering drugs to remote locations . Surgical center drug shortages impact anesthesia and chemotherapy drugs most severely, creating problems for ambulatory surgery centers that depend heavily on these drugs for patient care. While seemingly inconsequential drug shortages can have fatal consequences as physicians find new substitutes for scarce drugs.
Unlike most players in the healthcare continuum, the U.S Food and Drug Administration (FDA) is uniquely poised to lead a carefully orchestrated and multifaceted effort to manage the drug shortage crises – The sole objective of the FDA is to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products.The FDA is also responsible for coordinating federal responses to drug shortages. Thus with the growing challenge of drug shortages the pressure on the FDA has also grown . In response the FDA has taken on the herculean task of working with stakeholders such as drug manufacturers and suppliers to prevent and respond to drug shortages in surgical centers. The FDA’s working model to manage drug shortages is simple; learn about an impending drug shortage as early as possible and bring critical stakeholders like manufacturers and suppliers together to prevent or ameliorate such a potential shortage.
At the core of the push to track and prevent drug shortages is the Center for Drug Evaluation and Research (CDER) (2). The CDER tracks shortages in both prescription and over the counter medications . The CDER’s drug shortage program (DHP) receives notifications from manufacturers, Health care centers, surgical centers and wholesalers and validates this potential shortage information with manufacturers. Upon confirming shortage the CDER activates a series of tools and strategies to mitigate and limit the potential drug shortage. The FDA currently employs two main approaches to managing drug shortages; prevention of drug shortages and response to drug shortages (3) .
To prevent drug shortages the FDA has three main strategies; expediting the review and approval of new manufacturing sites and new suppliers, exercising regulatory flexibility and discretion and asking other firms to increase production. To respond to drug shortages the FDA has three main strategies; Asking other firms to increase production, expediting review of regulatory submissions and exercising regulatory discretion such as controlled importation of similar products approved abroad but not in the U.S. Other efforts by the FDA to curb the growing shortage of drugs in surgical centers include writing a letter to drug manufacturers reminding them of their current legal obligation to notify the FDA in advance of drug shortages and supporting legislation that requires early notification from manufacturers on impending drug shortages.The role of the FDA as a facilitator, managing drug shortage is complicated by the lingering perception that the FDA itself is partly responsible for drug shortages because of its intense regulatory activities. Today most of the FDA’s operational powers with regards to managing drug shortages come from section 506c (4)of the FD&C act which requires the sole source manufacturer of certain drugs (life sustaining or intended for use in the prevention of debilitating disease) to notify the agency at least six months prior to the date of discontinuation of the manufacture of such a drug. However this act does not provide the FDA with any explicit enforcement authority, leaving it relatively impotent. In response to this impotence, a recent bill ( S. 296) proposed by senator Klobuchar expands the 6 month rule by requiring manufacturers of all drugs (not just life threatening drugs) to report all supply disruptions or product discontinuations that could lead to shortages six months in advance or as soon as practicable or face very stiff penalties (5).
On the executive level, the Obama administration, also recently signed an executive order directing the FDA to streamline the process of approving changes to production lines (6) . This streamlined process should make it easier for drug manufacturers to respond more rapidly to notifications by quickly ramping up production of drugs anticipated to be in short supply.While individually important, these measures by the government and FDA remain only a small part of a desperately needed multi faceted approach to stem the growing crises of drug shortages in surgical centers around the country.
While some progress has been made by the FDA, it is clear that the challenge of ending drug shortages is a very daunting task. A look at the FDA’s public drug shortage inventory online shows that this challenge is not going away any time soon. Resolving drug shortages both domestically and internationally will require the brilliance and ingenuity of young scientist, public health scholars and entrepreneurs who can adapt emerging technologies and models to crack this intransigent public health conundrum.
2. Center for Drug Evaluation and Research, Food and Drug Administration. Manual of Policies and Procedures (MAPP). Available at:
3. A review of FDA’s approach to medical product shortages. Press release October 31, 2011. Available at http://www.fda.gov/DrugShortageReport
4. 21 U.S.C. 356c
5. Preserving Access to Life‐Saving Medications Act, S. 296, 112th Cong., 2011.
6.“Executive order–reducing prescription drug shortages”. Office of the press secretary, The white house October 31st 2011
7. FDA schematic on drug production and distribution to prevent shortage. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm