Immediate reaction to the rule was mixed. "Our initial read of the language is positive and we are encouraged that the agency's proposed definitions are consistent with previous rules," said Christopher Topoleski, director of federal regulatory affairs at American Society of Health-System Pharmacists.
But there could be some downsides to increased transparency, said Devon Herrick, a senior fellow at the conservative National Center for Policy Analysis. He noted that hospitals and other providers tend to hoard certain drugs to ensure they don't get caught without inventory after hearing about a shortage. The FDA also cited this as a possible issue in an October 2011 report.
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 last month, there are a total of 294 active shortages.
The FDA became more aggressive in having manufactures report manufacturing 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 and intravenous cancer drugs, and cefotaxime injection, an antibiotic manufactured by both Hospira and Baxter.
Also in short supply are a dopamine injection manufactured by Hospira as well as American Regent and used to treat circulation problems caused by heart attack, and cortisone acetate tablets made by West-Ward, which treats congenital adrenal hyperplasia and other issues.
Even with the proposed rule, experts say healthcare stakeholders shouldn't expect a quick end to drug shortages.
"The shortages that are ongoing are not going away because most are due to quality problems that take a long time to fix," said Erin Fox, director of the Drug Information Service at University of Utah Health Care.
The FDA's strategic plan includes updates to the FDA website making it easier to find out about shortages, their causes and how long they might last. Also, the FDA is launching a new mobile app to alert relevant stakeholders of shortages.
"This will allow for a more targeted communications approach with particular physicians affected by a shortage," Valerie Jensen, associate director of the drug shortages program at the FDA's Center for Drug Evaluation and Research, said during a press call Thursday.
Early in 2014, the U.S. Government Accountability Office is scheduled to release a report on whether the contracting policies of group purchasing organizations are a cause of drug shortages.
