Obama Orders FDA to Step Up Efforts to Prevent Medicine Shortages

President Barack Obama has signed an executive order to direct the Food and Drug Administration step up efforts to prevent shortages of vital drugs. As The Associated Press reports, Obama said the aim is to combat a “slow-rolling problem” that puts patients at risk and raises the potential for price gouging.

The executive order instructs the FDA to step up its tracking of potential medicine shortages and to speed its reviews of applications for beginning or changing the production of drugs facing possible supply shortages

Obama also emphasized the need to prevent price gouging. In a news release, the White House cited a report of a leukemia drug, whose typical price is about $12 per vial, being sold for $990 per vial.

The shortages tend to involve cancer drugs, anesthetics, drugs used in emergency medicine and electrolytes needed for intravenous feeding. In some cases, surgeries and cancer treatments have been delayed, and hospitals have been forced to buy from secondary suppliers at huge markups.”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,” Obama said.

The president ordered the new steps without congressional approval. Obama said the White House would continue to push lawmakers to pass  legislation pending in Congress to prevent drug shortages, but said “we can’t wait for action on the Hill, we’ve got to go ahead and move forward.”

As The New York Times reports, so far this year at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections and other diseases have been declared in short supply. The shortages have forced patients with curable diseases to take medicines that may not be as effective.

In the worst known case linked to the shortages, Alabama’s public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given because the sterile premixed liquid wasn’t available.

The president’s order is not considered likely to resolve the problem soon or entirely. Administration officials characterized it as one step in a long effort. While responding to problems in the drug supply chain, Obama eschewed more ambitious proposals — such as federal drug stockpiling or manufacturing — that would have injected the government more directly into the nation’s drug market.

STUART SILVERSTEIN

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