Obama to order FDA to help reduce drug shortages

[October 31, 2011]  WASHINGTON (AP) -- Acting once again ahead of Congress, President Barack Obama is directing the Food and Drug Administration to take steps to reduce drug shortages, an escalating problem that has placed patients at risk and raised the possibility of price gouging.

A White House official said the president planned to sign an executive order Monday instructing the FDA to take action. The order would be the latest in the president's campaign to move on initiatives that do not require congressional approval.

Last year, the FDA reported 178 drug shortages, and the agency says it continues to see an increase in shortages this year. These scarcities tend to affect cancer drugs, anesthetics, drugs used in emergency medicine, and electrolytes needed for intravenous feeding.

Obama also will announce his support for House and Senate legislation that would require drug makers to notify the FDA six months ahead of a potential shortage, the official said. Under current regulations, drug manufactures are only required to notify the FDA if medically necessary drugs are being discontinued. Notification of shortages is strictly voluntary.

The White House official spoke on the condition of anonymity because the order had not been officially announced.

The executive action is part of an overarching push by the White House to portray Obama, who is facing re-election, as an effective counterpoint to congressional Republicans blocking his jobs legislation. Last week, he issued an executive order to help homeowners refinance at lower mortgage rates and to allow college graduates to simplify and lower their student loan payments. On Friday he directed government agencies to shorten the time it takes for federal research to turn into commercial products in the marketplace

The FDA says major causes of drug shortages are quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of newer medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug.

Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Peggy Hamburg were expected to join Obama at the White House on Monday when he signed the executive order.

Also invited to attend was a Boston hospital pharmacy manager who has regularly encountered drug shortages, and a 49-year-old San Francisco cancer patient who told an FDA workshop last month how he grappled with a shortage in his chemotherapy drug.

[Associated Press; By JIM KUHNHENN]

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