CHICAGO, IL–(ENEWSPF)–March 2, 2012. Families of sick children and adults—and the medical professionals who care for them—should not have to worry about where they are going to find the next dose of life-saving drugs, U.S. Senator Dick Durbin (D-IL) said today at Children’s Memorial Hospital. The bipartisan Preserving Access to Life-Saving Medications Act, of which Durbin is a co-sponsor, would require drug manufacturers to notify the U.S. Food and Drug Administration of a disruption to a drug supply six months in advance—under threat of financial penalty—giving the FDA an opportunity to prevent the shortage, notify providers and develop a contingency plan.
“Over the past few years, the hardworking doctors, nurses, and pharmacists at Children’s Memorial hospital – and at hospitals all over Illinois – have become all too familiar with this troubling scenario: their patient arrives for chemotherapy or another treatment only to discover that the critical drug needed to save their life is not available. This is a situation in which no doctor and no patient should ever find themselves. Congress must work to pass a comprehensive solution to ease the burden on hospitals and pharmacies and to ensure that patients are receiving the best drug therapies available,” Durbin said.
Multiple factors contribute to drug shortages including disruptions in the availability of raw supplies, manufacturing problems, limited manufacturing capabilities, delayed oversight and the termination of drug manufacturing due to low profit margins.
Children’s Memorial Hospital is currently running short of 70 drugs—including 15 drugs used to treat cancer. A shortage of a drug used to treat an illness—such as the one experienced recently in parts of the country for a childhood leukemia medicine—can force medical professionals to treat some patients with an alternative. Alternatives may have additional side effects and require closer monitoring of a patient’s safety, which increases the burden on hospital staff. Drug shortages have particularly negatives consequences for younger patients, because most alternative drugs have not been tested on children.
Originally introduced in February 2011, the Preserving Access to Life-Saving Medications Act would require the U.S. Department of Health and Human Services to create criteria for identifying potential drug shortages and require the FDA to work with the manufacturer to maintain a drug supply. HHS would also report the actions taken to address a shortage to Congress.
In October of 2011, President Obama issued an executive order advancing the key provision in the bill, which urged pharmaceutical companies to notify the FDA of impending prescription drug shortages. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies. Additionally, the FDA further expanded requirements on certain manufacturers of lifesaving, medically necessary drugs.