President targets medicine shortages

FDA ordered to press drugmakers

WASHINGTON – President Barack Obama is pushing federal regulators to do more to address dangerous shortages of critical medicines, sidestepping a deadlocked Congress that has not dealt with the problem.

In an 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 shortages.

The order, which administration officials concede does not give the FDA any new authority, also ordered the agency to expedite reviews of new manufacturing facilities.

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

“Congress has been trying since February to do something about this,” Obama said at the White House. “It has not yet been able to get it done. … We can’t wait for action on the Hill.”

The White House action comes amid mounting alarm among physicians, patients and others about the unavailability of some drugs to treat cancer, to control infections, even to provide basic electrolytes to patients who need intravenous 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.

Some shortages have resulted from quality problems in manufacturing. But others have been caused by drugmakers’ decisions to stop making some products and by an increase in demand for some drugs that outstrips supply.

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

In detailing their plans, officials said the government will use existing authority to require drugmakers to more regularly report when drugs are discontinued, and when production disruptions might create shortages.

Several companies, trade groups, hospital leaders and patient advocates praised the executive order. Christopher W. Hansen, president of the American Cancer Society Cancer Action Network, called it an “essential step.”

The influential Pharmaceutical Research and Manufacturers of America was more cautious. “The implementation of the president’s executive order must effectively strike a balance between addressing a complex set of rare but nevertheless concerning issues in the manufacturing process while promoting a market environment that fosters accessibility,” said PhRMA President John J. Castellani.

The executive order is the latest in a series of initiatives in which Obama has tried to address problems including rising student loans, home foreclosures and unemployment among military veterans.

The Republican National Committee on Monday said Obama initially ignored the drug shortages and now was trying “to look like he’s doing something.”

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