FDA report analyzes problem, identifies action steps for agency
posted November 30, 2011
President Barack Obama signed an executive order Oct. 31 directing the Food and Drug Administration to take steps to attempt to reduce drug shortages, which have been arising mostly from supply disruptions.
In a report released that day, the FDA concluded that "drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care."
The presidential order particularly targets current shortages of sterile injectables, such as drugs for treating cancer or inducing anesthesia.
Shortages of drugs that the FDA has approved for human use increased from 61 in 2005 to 178 in 2010, according to the agency's report, "A Review of FDA's Approach to Medical Product Shortages." Many of these drugs are in use in veterinary practice.
Analyzing 127 shortages of drugs that occurred during 2010 and 2011, the FDA found that sterile injectables accounted for 80 percent of the shortages. By therapeutic class, cancer drugs accounted for 28 percent of the shortages.
Major causes of drug shortages include quality problems at the drug manufacturing facility and other delays in manufacturing or shipping. Other causes include shortages of active pharmaceutical ingredients and business decisions to discontinue production.
"While FDA has taken on the task of working with manufacturers to help prevent and mitigate these shortages, many of the root causes and potential solutions to the shortage problem lie beyond its purview," according to the report.
The FDA acts to help prevent drug shortages primarily by expediting regulatory reviews of new manufacturing practices, sites, and suppliers.
The presidential order on drug shortages directs the FDA to take the following steps:
- Require drug manufacturers to provide notice of manufacturing disruptions for certain drugs.
- Expedite regulatory reviews to help address drug shortages.
- Communicate to the Department of Justice any findings of drug stockpiling or price gouging.
The agency responds to existing drug shortages with steps such as asking other manufacturers to increase production, working with manufacturers to identify means to mitigate dangers of products with quality issues, and expediting regulatory reviews.
The FDA report noted that sterile injectables are more complex to manufacture than oral drugs are, leading to a greater likelihood of quality problems. For 60 percent of sterile injectables, one manufacturer produces at least 90 percent of the supply.
In conjunction with the FDA report, the Department of Health and Human Services released an issue brief focusing on market factors in shortages of sterile injectables.
The shortages appear to be "a consequence of a substantial expansion in the scope and volume of products produced by the industry that has occurred over a short period of time, without a corresponding expansion in manufacturing capacity," according to the brief.
As a result, any disruption in the supply of sterile injectables because of quality problems or other issues can lead to persistent shortages.
The president also called on Congress to pass the Preserving Access to Life-Saving Medications Act, H.R. 2245 and S. 296.
The legislation would require drug manufacturers to notify the FDA of product discontinuations or other supply disruptions that could lead to shortages of any drugs that the agency has approved for human use—not just medically necessary products—six months in advance or as soon as practicable after recognition of an impending shortage. The law would enable the FDA to impose monetary penalties on manufacturers that fail to adhere to reporting requirements.
The FDA report identified immediate actions for the agency to take to help reduce drug shortages.
The first action was for the FDA to send a letter to drug manufacturers, on Oct. 31, reminding them of current legal obligations to notify the agency in advance of certain product discontinuations and urging them to notify the agency voluntarily of other potential disruptions to the supply of drugs.
Other actions for the FDA include developing guidance and regulations to enhance the information that manufacturers submit on potential drug shortages, providing additional staffing resources for the agency's efforts to address drug shortages, and creating a database to analyze the characteristics of drug shortages.
The FDA called for comments on the report, which is available at www.fda.gov by searching for "medical product shortages." Parties may submit comments through Dec. 23 at www.regulations.gov by searching for "FDA-2011-N-0690-0002."