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.
FDA asks drugmakers for warnings about medicine shortages
The federal agency defines “medically necessary” medicines as drugs used to treat or prevent a serious disease or condition where there are no alternative medicines 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,” said Ilisa Bernstein, deputy director of compliance in FDA's Center for Drug Evaluation and Research, in an agency consumer update (PDF).
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 of the shortages involved sterile injectable drugs.
The FDA said that the recent shortages can be contributed to increased demand for some medicines, a company's decision to stop manufacturing some drugs, and quality and manufacturing problems for companies.
Legislation that would require drug manufacturers to provide warnings to the FDA about medicine shortages was introduced in February.
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.