President Obama is directing the FDA to take steps to curb drug shortages, a growing problem that has put patients in danger and raised the possibility of price gouging.
Cancer drugs, anesthetics, drugs used in emergency medicine, and electrolytes needed for intravenous feeding are the drugs that tend to be in short supply.
The shortages have been blamed for patient deaths, and hospitals have been forced to buy from secondary suppliers at huge markups. Surgical procedures and cancer treatments have been delayed.
Obama planned to sign an executive order Monday instructing the FDA to take action, a White House official said. 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 required to notify the FDA only if medically necessary drugs are being discontinued. Notification of shortages is strictly voluntary.
The FDA reported 178 drug shortages last year, and the agency says it continues to see an uptick in shortages this year. Major causes of drug shortages are said to be quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of new medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug.
In the worst known case linked to the shortages, Alabama’s public health department this spring reported nine patients died and 10 were harmed as a result of bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn’t available.
Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Peggy Hamburg were expected to join Obama at the White House as he signs the executive order.
Also invited to attend was a Boston hospital pharmacy manager who has 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.
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