Drug Shortages are Compromising Patient Health and Safety

The following is an opinion piece from State Senator Katherine Clark:

Shortages of drugs for some types of cancer and other serious medical conditions are affecting the health and safety of patients in the Commonwealth.  Insufficient supplies are also driving up the costs of healthcare.  A “shadow” market now exists where scare drugs are stockpiled and sold, legally, at a much higher price to hospitals desperate for these medicines. 

The U.S. government has reported that while only a small number of drugs experience a shortage in any given year, that number nearly tripled between 2005 and 2010, from 61 to 178.  This is an alarming trend. 

As a member of the Joint Committee on Public Health, I recently had the opportunity to hear from a panel of experts on this subject, including doctors, patient advocates, an FDA official, and leaders from Children’s Hospital, the Dana Farber Cancer Institute and others. 

This group, representing all sides of the healthcare industry, shared heartbreaking stories of patient suffering and the agonizing decisions they and their doctors must make about how to use scarce drugs.  One prominent example concerned Doxil, a drug used to treat ovarian cancer that last year was in short supply. Some women were simply not able to get the care they needed. 

This problem is also affecting our children.  An official at Children's Hospital explained that many of the drugs used to treat childhood leukemia are in short supply, in part because the number of suppliers is so small and pediatric drugs represent such a small fraction of the national pharmaceutical market.

Possible causes of these shortages are varied and complex, but experts point to a lack of adequately modern, high-tech production capacity by pharmaceutical manufacturers.  If there is only one supplier of a certain drug, any sort of production problem or contamination concern threatens every patient who needs that medication. 

The U.S. government also relies on a voluntary warning system for impending drug shortages.  As Dr. Sandra Kweder of the FDA’s Center for Drug Evaluation and Research explained, the federal government is examining ways to encourage drug manufactures to build new, modern facilities, while still maintaining current production under safe conditions, but cannot require them to do so.

While my colleagues and I will continue to look for ways for the state to mitigate the drug shortage impact, the real answer is with the federal regulation of pharmaceutical production. President Obama issued an important Executive Order last fall, and the FDA acted just last month to address the critical shortage of the Doxil and also methotrexate, which is used to treat many forms of cancer like acute lymphocytic leukemia (ALL) in children.

At the state level we will continue to partner with our Congressional delegation to tackle this issue comprehensively and give the FDA the tools it needs to aggressively and proactively confront this problem.  Our healthcare costs are already too high, but more importantly, we must do what we can to end the patient suffering.