Obama Signs Executive Order Directing FDA to Reduce Drug Shortages

On Monday, President Obama signed an executive order directing the United States Food and Drug Administration (FDA) to take measures which will reduce drug shortages. By signing the executive order, however, the President has bypassed Congress’ approval of the action, leaving many to question whether political motives were behind the order, as well as how effective this action will be in the long run.

The FDA reported 178 drug shortages last year alone, the bulk of which were cancer drugs, anesthetics, electrolytes, and emergency room drugs. This year, those shortages have increased.

In a statement released before signing the order, the President said, "Even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all across the country. Congress has been trying since February to do something about this,” President Obama continued. “It has not yet been able to get it done. And it is the belief of this administration...is that we can't wait for action on the Hill."

The President’s executive order directs the FDA to:

• Urge drug manufacturers to report potential drug shortages or discontinued products as far in advance as possible, six months being the ideal time frame
• Accelerate regulatory review of drugs
• Evaluate "certain behaviors" by market participants, including actions such as collecting drugs and reselling them at drastically increased prices

These changes could shake up the drug manufacturing industry. Currently, drug manufacturers are only required to notify the FDA on the discontinuation of medically essential drugs; notifications on shortages are voluntary.

The American Hospital Association (AHA) Executive Vice President Rick Pollack reported that the order "comes at a critical time and is welcome news for hospitals and the patients they care for. The number of drug shortages has tripled in the last six years and the shortages are affecting patient care." According to a survey conducted by the AHA, almost 100% of American hospitals have reported shortages in the past six months, and the majority of them did not receive any notification from manufacturing companies prior to the shortages. "Clinicians need more notice from drug manufacturers so they have time to act to ensure that patient care is not disrupted," Pollack stated. "Hospitals are doing their best to reduce the impact of shortages by increasing inventories, buying alternative drugs, and training clinical staff on how to deal with drug shortages." Although the AHA supports the president's order, however, Pollack suggests that Congress work next on passing bipartisan legislation entailing drug corporations to inform the FDA about disruptions in supply or discontinuations immediately.

While many are applauding the resolve shown by the President through this action, others are skeptical. This executive order will be the President’s fifth this week, including the executive order he signed on Friday giving orders to government agencies to reduce the time it takes for federal research to result in commercial products on the market. With the Presidential electionions approaching, some cannot help but feel there may be an ulterior motive behind the President’s latest bypass of congress.

On the recent executive orders, Americans for Limited Government President Bill Wilson stated that "they overstep the president's constitutional boundaries.” Aside from the potential political motives that may have driven this order, the Director for Clinical Pharmacy Solutions at Novation, Steven Lucio, reported that he was pessimistic about the effect the order will have on the shortage situation. “This is a free market and that is what we have to understand. The government can't force drug companies to make products. Unless we want to change that—and there is a lot of sensitivity these days about what it is practical for the government to do—I don't think it can be done and I don't think it is appropriate."

According to Lucio, the FDA currently only employs four people in its drug shortage division to monitor 178 to 211 drug shortages."Four people can't manage that," he said.

Blair Childs, senior vice president of Public Affairs at Premier healthcare group purchasing organization, urged providers not to depend on the government to find all of the answers to the drug shortage issue. "There are things the government can do that are positive, but there are things we need to do in the private sector," Child stated. "We need to work with manufacturers and distributors to manage or mitigate the disruptions that occur in the market.”

“How do we help ensure that the products are shared broadly and allocated effectively, that there is a heads up so that folks are preparing when there is an impending shortage. Those are the things we talk to distributors about,” Childs concluded.