For the last few years, the U.S. has been experiencing an increasing frequency of drug shortages, which have caused a number of difficulties for clinicians and patients. Medication shortages are caused by many factors, including difficulties in acquiring raw materials, manufacturing problems, regulatory issues, and natural disasters. Shortages can adversely affect patient care when alternative treatments are substituted for safe and effective therapies. Shortages can also compromise or delay medical procedures; or may cause medication errors and can significantly burden health care providers' finances and personnel.
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, on the agency's response to ongoing drug shortages for critical products