The Food and Drug Administration is asking U.S. pharmaceutical companies to provide warnings about production shortages for “medically necessary” medicines, although drugmakers do not face legal penalties if they do not.
Late News: FDA wants shortage warnings on 'medically necessary' meds
The federal agency defines “medically necessary” medicines as drugs used to treat or prevent a serious disease or conditions where no alternative medicines are available. “FDA is urging drugmakers to voluntarily notify us if they change production quantities of drugs as a matter of corporate responsibility and in the interest of public health,” Ilisa Bernstein, deputy director of compliance in FDA's Center for Drug Evaluation and Research, said in an agency consumer update. Drug shortages have nearly tripled from 2005 to 2010, according to the FDA. Last year, 178 drugs shortages were reported, including cancer drugs, anesthetics, “crash cart” drugs used in emergencies and electrolytes for patients who are fed intravenously. The FDA said most shortages involved sterile injectable drugs.
The recent shortages can be attributed to increased demand for some medicines, decisions to stop manufacturing some drugs, and quality and manufacturing problems, the FDA said.
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