GPOs Back Obama Order on Drug Shortages

The American Hospital Association and two hospital group purchasing organizations say they support President Barack Obama's executive order this week to reduce the nation's prescription drug shortage.  

Steven Lucio, director for clinical pharmacy solutions at Novation, told HealthLeaders Media that the federal government really can't go much beyond the president's order. "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."

Lucio says that the Food and Drug Administration now has only about four people in its drug shortage division monitoring anything from 178 to 211 drug shortages."Four people can't manage that," he said. 

While there have been calls to ease restrictions on importing prescription drugs that are in short supply, Lucio says that probably wouldn't work all that well. "The problem is you can't find it," he said.

"If there is a product to be found they will go and try to get it. It's just [that] we can't take all the medication from Europe. However, if the FDA has greater notifications maybe they can do something with a foreign government that would have more time to respond. "

The executive order calls on the FDA to:

• Press drug manufacturers to report as far in advance as possible on the potential shortages or discontinued product;
• Expedite regulatory review of drugs; and
• Review "certain behaviors" by market participants that could include hoarding drugs and reselling them at exorbitant prices

"The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety," Obama said Monday in prepared remarks. "This is a problem we can't wait to fix. That's why today, I am directing my administration to take steps to protect consumers from drug shortages, and I'm committed to working with Congress and industry to keep tackling this problem going forward."

Blair Childs, senior vice president of Public Affairs at Premier healthcare group purchasing organization says that providers shouldn't wait on the government to supply all the answers to the drug shortage problem.

"There are things the government can do that are positive, but there are things we need to do in the private sector," he said. "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 believes that much of the president executive order will do little if anything to solve the short-term shortage of prescription drugs. "But it will help reduced the problems in the longer term. The ultimate long term solution is they need to speed approval at FDA and also for both the new generic products and the active pharmaceutical ingredients," he said.

AHA Executive Vice President Rick Pollack said in a prepared statement 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."

An AHA survey this year found that nearly 100% of hospitals reported a shortage in the past six months, but that most of them rarely -- if ever -- received advance notification of these drug shortages.
"Clinicians need more notice from drug manufacturers so they have time to act to ensure that patient care is not disrupted," Pollack said. "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."

While AHA supports the president's order, Pollack says Congress must step up to pass bipartisan legislation that requires drug companies to tell the FDA as soon as possible of interruptions in supply or discontinuations.

"In addition, we believe that obstacles must be removed so that FDA is able to streamline approval of drugs in shortage," Pollack said.