Obama Orders FDA to Zero In on Drug Shortage Crisis

President Obama signs an Executive Order directing the Food and Drug Administration to take action to help prevent and reduce prescription drug shortages on Oct. 31, 2011. Photo by Kristoffer Tripplaar-Pool/Getty Images.

President Obama called for swift government action Monday against a drug shortage crisis that’s increasingly left doctors and hospitals scrambling for life-saving medications — often including those used in cancer and emergency treatment.

The executive order from the White House called on the Food and Drug Administration to broaden its reporting of potential drug shortages, speed up the review of applications from companies wishing to change production of drugs facing a potential shortage, and pass along more information to the Justice Department regarding instances of suspected collusion or price gouging.

“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 over the country,” the president said.

At the same time, Obama strongly supported legislation that’s working its way through both houses of Congress that would force drug makers to notify the FDA six months before a potential shortage. Currently, manufacturers only need to alert the agency if medically necessary drugs are discontinued. Shortage notifications are strictly voluntary.

But the president also said “we can’t wait for action on the Hill, we’ve got to go ahead and move forward.”

It’s just the latest in the “We Can’t Wait” campaign, a series of executive actions designed to circumvent congressional Republicans who are currently blocking Obama’s jobs bill. Even so, the executive order is designed as little more than a stopgap to help incrementally improve the drug shortage crisis until Congress acts.

Last year alone, the FDA reported 178 drug shortages caused by a range of factors, including manufacturing problems and the simple fact that many companies abandon production of life-saving medications after their patents expire and they become less profitable.

The consequences have been dire.

As NewsHour Health Correspondent Betty Ann Bowser reported in August, a survey of American Hospital Association members recently found that 82 percent of patients who couldn’t get medications on the shortage list experienced delayed treatment. For those who were given a substitute, 69 percent were given medicine known to be less effective.

Watch Drug Shortages Force Tough Choices for Patients, Doctors on PBS. See more from PBS NewsHour.

The medications on the shortage list are mostly low-cost generics given in hospital settings. But they are also critical drugs — ones used to keep patients in the intensive care unit alive, anti-cancer drugs for which there may be no substitute, anesthetics and medications crucial for some surgeries.

Most of the other 40 percent on the list are brand-name drugs still under U.S. government patents, for which there are no generic equivalents. And few of them are critical to patient care.

The president’s executive order “echoes a priority of America’s biopharmaceutical research companies,” according to John J. Castellani, president and CEO of the pharmaceutical trade group PhRMA.

“Patient access to innovative treatments is the cornerstone of our industry. That is why the critically important issue of drug shortages demands our collective attention to ensure patients can access the medicines they need in the most expeditious manner possible,” Castellani said in a statement.

Both Obama administration and Castellani railed against the unscrupulous vendors fueling the situation through the so-called “gray market” — a hazy industry in which secondary retailers buy up medication outside of the normal, tightly controlled pharmaceutical distribution channels. When the moment is ripe, the companies then sell their stockpiled supplies to desperate pharmacists and hospitals at exorbitant mark-ups.

High blood pressure medication that normally costs $25.90, for example, can go for $1,200 — a mark-up of 4,533 percent.

Rep. Elijah Cummings, D-Md., the ranking member of the House Committee on Oversight and Government Reforms, has been leading a congressional investigation into the gray market for several months.

“The idea that some companies may be taking advantage of cancer patients and others in such vulnerable positions is criminal, and we are taking action to get to the bottom of this,” he wrote in a statement.