Obama Orders FDA To Curb Drug Shortages

President Obama signed an executive order Monday directing the Food and Drug Administration to take action to reduce prescription drug shortages, which the White House says have endangered patients and led to price gouging.

“Recently we have seen how the potential of drug shortages for vital drugs, including some cancers, can really have an adverse impact on patients and those who are caring for patients. Sometimes we run out of or run low on certain types of drugs and that drives up prices and it increases patient risk,” President Obama said at the signing in the Oval Office.

The new executive order instructs the FDA to take action in three areas: broaden reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages, and examine whether potential shortages have led to illegal price gouging.

According to the White House, these additional steps will help achieve some of the goals of bipartisan legislation currently in Congress that would strengthen the FDA’s ability to prevent prescription drug shortages in the future. The president supports the pending legislation.

What the Executive Order does not do, however, is give the president any new authority. White House officials today made clear that this action simply “enhances” and “amplifies” steps that are already being taken by the FDA to monitor and prevent drug shortages.

“The Executive Order does not grant us new authority beyond what the legislation on the books has already done,” HHS Secretary Kathleen Sebelius told reporters on a conference call this afternoon.

In addition to expediting review of drug suppliers and new manufacturing sites to prevent shortages, the administration also announced it is adding five new staffers to the FDA’s Drug Shortages Program and sending a letter to manufacturers to remind them to report the discontinuation of certain drugs.

Today’s action is part of the president’s continuing “ We Can’t Wait” campaign to take unilateral action to boost the economy without the need for cooperation from Republicans in Congress, who are blocking the president’s $447 billion  bill to spur job growth.

“Over the last five years the number of these drug shortages has nearly tripled. Even though the FDA has 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,” Obama said today. “Congress has been trying since February to do something about this. It has not yet been able to get it done and it is the belief of this administration… that we can’t wait for action on the Hill. We’ve got to go ahead and move forward.”

The president was joined at today’s signing by Bonnie Frawley, a Pharmacy Manager for perioperative services at the Brigham and Women’s Hospital in Boston, Mass., and Jay Cuetara, a 49-year-old cancer patient who lives in San Francisco, Calif.