Obama executive order targets drug shortages

President Obama on Monday is pushing drugmakers and federal regulators to do more to address dangerous shortages of critical medicines, sidestepping a deadlocked Congress that has not moved legislation to help patients suffering from deadly illnesses.

In a limited executive order signed Monday, the president directed the Food and Drug Administration to press drug companies to more quickly report shortages to federal regulators, an early warning that advocates say can help mitigate problems.

The order, which administration officials said does not give the FDA any new authority over drugmakers, also ordered regulators to expedite review of new manufacturing facilities.

And it directed the FDA to work with the Department of Justice to step up investigation of increasing reports of price gouging in the pharmaceuticals market.

“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,� Obama said in a statement.

“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.�

The White House action comes amid mounting alarm among physicians, patients and others about the rising unavailability of drugs to treat cancer, to control infections, to anesthetize patients before surgery, even to provide basic electrolytes to patients who need IV feeding.

There were 178 drug shortages reported to the FDA in 2010, according to the agency. And this year, federal regulators have seen a continuing surge in reported shortfalls.
Many of the shortages have resulted from quality problems in the manufacturing of drugs.

But the FDA has also seen disruptions caused by drugmakers’ decisions to stop production of some products and rising demand for some drugs that is outstripping supplies.

“That’s not something we can control,� Secretary of Health and Human Services Kathleen Sebelius acknowledged Monday. “We can’t fix the capacity issue.�

But administration officials said the federal government could take some steps to address some of the problems. “We know we can do better,� said Dr. Margaret Hamburg, the FDA commissioner.

The executive order follows a parade of recent initiatives in which the president has used his executive authority to take on problems including rising student loans, home foreclosures and persistent unemployment among military veterans.

The president has argued these moves are necessary in the face of partisan gridlock on Capitol Hill. But some of the executive orders have drawn criticism from Republicans, who have accused the president of election politicking.

The Republican National Committee on Monday called Obama’s FSA order “just more words� in a news release that proclaimed: “Obama ignores years of headlines warning about drug shortages; finally decides to look like he’s doing something for political expediency.�

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