President Obama ordered federal regulators Monday to step up efforts to prevent shortages and price fixing of life-saving prescription drugs, the latest White House initiative that does not require congressional approval.
Obama’s executive order directs the Food and Drug Administration to more broadly enforce reporting requirements for manufacturers running low on drugs, expedite review of new prescription drug suppliers and work with the Justice Department to prosecute price gouging.
“There’s a combination of tools that are going to be contained in this executive order that can make sure that life-saving drugs are available, and if we start seeing shortages, that we’re able to catch those ahead of time,” Obama said before signing the mandate in the Oval Office.
The number of shortages of crucial drugs has increased dramatically in recent years to at least 232 this year, industry experts said. This list includes some of the most commonly used drugs in hospitals that are designed to care for cancer patients, heart attack victims and accident survivors.
Administration officials said the executive order is not meant to supplant legislation pending in Congress that would require drug companies to notify the FDA of potential shortages far earlier than is mandated under current federal law.
Rather, the order is intended to marshal the government’s regulatory and administrative powers to address the growing problem, said Health and Human Services Secretary Kathleen Sebelius.
In that regard, experts said the executive order is unlikely to have any immediate effect, given that it does not address the fundamental problems causing the shortages.
The causes vary from drug to drug, but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, snags can quickly spiral into shortages.
“The executive order is good because it raises awareness, but unfortunately the order isn’t targeting anything that could help prevent shortages,” said Erin Fox of the University of Utah, who monitors drug shortages for the American Society of Health-System Pharmacists. “Asking FDA to post more shortages won’t get the industry to improve their manufacturing or help secure a market for much-needed drugs.”
The Obama administration’s response is limited in part because the White House is acting only in areas that do not require congressional approval. With his $447 billion American Jobs Act stalled in Congress, the president last week began rolling out smaller-scale executive actions, including providing mortgage relief to underwater homeowners and college graduates repaying student loans.
The steps are intended to put pressure on the GOP to support the president’s larger economic policies or risk being painted as a party unwilling to act during a crisis.
Obama’s executive order Monday did not include more aggressive steps that some health advocates had suggested, such as creating a national stockpile of drugs that could be tapped to alleviate shortages. Administration officials said they examined that possibility and concluded it could do more harm than good.
“There really is not an effective way to predict which drugs are going to come into shortage,” FDA Commissioner Margaret A. Hamburg said during a conference call with reporters. “Trying to anticipate which drug might go into shortage might create a shortage.”
No organization has systematically tracked the toll of the shortages, but news media across the country have reported on delays in treatments for cancer and other illnesses, anxious searches for desperately needed drugs, devastating injuries from mistakes and less-adequate drugs, and even deaths.
Federal regulators have been rushing to alleviate the shortages, sometimes helping firms resume production more quickly or approving emergency imports of supplies from overseas. Officials said they had prevented 137 shortages, including 99 this year.
Public health officials praised the White House for raising public awareness about the problem.
“It raises this to a presidential level, which is a good thing,” said Kasey K. Thompson of the American Society of Health-System Pharmacists.
To meet the additional regulatory burden under the executive order, the FDA said it would increase the number of people working in the drug-shortage program from five to about 11 and add two staff members to the Office of Compliance.
“Where are the resources going to come from?” Thompson said. “We know the FDA is a terribly underfunded agency.”