Pres. Obama acts without Congress to hasten production of medicines for life-threatening illnesses

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WASHINGTON — President Barack Obama will issue an executive order Monday that the administration hopes will help resolve a growing number of critical shortages of vital medicines used to treat life-threatening illnesses, among them several forms of cancer and bacterial infections.

The order offers drug manufacturers and wholesalers both a helping hand and a gloved fist in efforts to prevent or resolve shortages that have worsened greatly in recent years, endangering thousands of lives.

It instructs the FDA to do three things: broaden reporting of potential shortages of certain prescription drugs; speed reviews of applications to begin or alter production of these drugs; and provide more information to the Justice Department about possible instances of collusion or price gouging . . .

The order, the first since 1985 by a president to affect the functions of the Food and Drug Administration, is part of a series of recent executive orders involving such disparate issues as mortgage relief and jobs for veterans . . .

“The president’s action is a recognition of the fact that this is a serious problem, and we can and should do more to help solve it,” said an administration official who asked to remain anonymous to avoid upstaging the official announcement on Monday. “We can’t wait anymore.”

read: http://www.omaha.com/article/20111031/AP/111039976


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.

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.

read: http://www.newsday.com/business/obama-to-order-fda-to-help-reduce-drug-shortages-1.3285364