Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury.
Rep. Elijah E. Cummings (D-MD) alleges that secondary drug distributors are charging exorbitant prices for drugs that are in short supply. Allied Medical Supply, for example, has charged $990 per vial of cytarabine, a treatment for leukemia that usually costs about $12 per vial. A shortage of leucovorin, which is used to treat advanced colon cancer, has enabled Premium Health Services to charge more than $270 per vial, even though the drug’s typical price is approximately $5 per vial. On behalf of the House Committee on Oversight and Government Reform, Cummings has sent these companies letters asking how much they are making in profits on these drugs.
The biggest cause of drug shortages, according to FDA, is manufacturing quality problems. Fortunately for us, FDA just awarded a multimillion-dollar grant to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug development and manufacturing. NIPTE, a not-for-profit research organization, will use the money for various projects that could help manufacturers better understand their products and processes. For example, NIPTE will seek to develop analytical methods that can characterize complex molecules and enhance control of product quality. The group also will investigate specialized manufacturing techniques for low-dosage and high-toxicity products.
By improving manufacturing quality, NIPTE’s work could help reduce the number of future drug shortages that patients must endure. And FDA will soon provide recommendations for avoiding and mitigating drug shortages. FDA’s efforts are a good sign that it takes the problem seriously, but for many patients, relief cannot come too soon.