FDA initiatives target drug shortages

The Food and Drug Administration is addressing potentially life-threatening drug shortages with two new initiatives announced last week.

The agency released a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the agency of manufacturing interruptions that could lead to a scarcity of the product. The rule includes manufacturers of biologic products. The FDA also released a strategic plan that outlines various activities the agency is undertaking to get to the root causes of shortages, how long they might last and how they can be avoided.

As of Sept. 30, there were 109 new shortages this year, according to the University of Utah Drug Information Service. As of the end of October, there are a total of 294 active shortages.

The FDA became more aggressive in having manufacturers report production halts after President Barack Obama signed an executive order two years ago requiring the FDA to increase enforcement of reporting requirements for manufacturers running low on drugs. This action came after hospitals reported their worst shortage of oncology drugs in nearly a decade.

Drugs in short supply include electrolytes, vitamins, and fluids for resuscitation and treatment of premature babies; liquid nutrition for patients; intravenous cancer drugs; and the injectable antibiotic cefotaxime.

Erin Fox, director of the Drug Information Service at University of Utah Health Care, Salt Lake City, said no one should expect a quick end to the shortages because “most are due to quality problems that take a long time to fix.”