By: Capt. Valerie Jensen, R.Ph.
I’ve led FDA’s efforts to address hundreds of drug shortages for more than 10 years. During that time, we’ve made progress. Just last year, we cut the number of new shortages by more than half. But more work needs to be done.
In an effort to enhance FDA’s current approach to drug shortages and bring new ideas to reduce the number of patients who are affected, we provided Congress today with a strategic plan aimed at enhancing efforts to prevent and reduce drug shortages. FDA is actively working, as required by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, to address the public health threat caused by critically needed medications being unavailable for patients. And we will continue that work and build on our progress.
An important part of our work is understanding the impact on patients. I’ve talked with many patients and caregivers about the effects of drug shortages. It deeply saddens me to hear a mother talk about her new baby boy, born prematurely, who is struggling to survive due to the scarce supply of drugs to meet his nutritional needs. Or a husband whose wife has been battling cancer and her doctor says the hospital is running out of the medication needed to properly treat her.
I’m often asked, “Why do drug shortages persist?” and “Why are so many lifesaving drugs in shortage?” The majority of these problems stem from quality and manufacturing problems. Therefore, the answers boil down to quality manufacturing.
While “quality manufacturing” may sound like a simple concept, getting there is a complex process – and one in which FDA and outside stakeholders have important roles to play.
The strategic plan includes a number of new ideas to address shortages. Many of these strategies focus on enhancing FDA’s response and communication when we become aware of quality or manufacturing issues that could lead to a shortage. Other strategies that FDA is considering include the development of new risk-based approaches to identify early warning signals for manufacturing and quality problems that could lead to production disruptions.
In addition, the strategic plan identifies some preventive measures companies can take that place a greater emphasis on manufacturing quality and stability of supply, thereby eliminating the root causes of most shortages.
Better manufacturing quality will help eliminate drug shortages over the long-term. But when a manufacturing disruption is likely to occur, early notification by manufacturers is critical. Along with the strategic plan, therefore, FDA is today issuing a proposed regulation implementing the expanded early notification requirements included in FDASIA. This regulation would require that all manufacturers of certain medically necessary prescription drugs give FDA advance notice of a permanent discontinuance or a temporary interruption of manufacturing. It would also extend this requirement to manufacturers of biologic products.
Advance notification of a potential shortage allows FDA to work closely with manufacturers on the underlying issues, and in many cases, we are able to prevent the shortage.
FDA envisions all stakeholders coming together to ensure patients have access to the safe, effective, and high-quality medications they rely on and deserve, and we believe the strategic plan we presented to Congress today will make great strides in ensuring that happens.
Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research