President Barack Obama is directing the FDA to take steps to reduce drug shortages, an escalating problem that has compromised patient safety and raised the possibility of price gouging.
In 2010, the FDA reported 178 drug shortages, a number that is expected to increase this year. Medications often affected by shortages include oncology drugs, anesthetics, drugs used in emergency medicine, and electrolytes needed for intravenous feeding. As a result of insufficient supplies, hospitals have been forced to buy from secondary suppliers at significant markups, and a number of surgeries and cancer treatments have been delayed.
According to an Associated Press report
, a White House official said that Obama planned to sign an executive order instructing the FDA to take action in 3 areas:
Broadening its reporting of potential drug shortages
Accelerating reviews of applications to change production of drugs facing potential shortages
Giving the Justice Department more information about possible instances of collusion or price gouging.
The executive order would be the latest in the president’s campaign to move on initiatives that do not require congressional approval.
Obama also will announce his support for House and Senate legislation that would require drug manufacturers to notify the FDA 6 six months prior to a potential shortage, said the official, who spoke on the condition of anonymity because the order had not been officially announced. Under current regulations, drug makers are only required to notify the FDA if medically necessary drugs are being discontinued. Notification of shortages is strictly voluntary.
Experts believe that among the more common causes of drug shortages are quality or manufacturing problems, along with 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.
Earlier this year, Alabama’s public health department reported 9 deaths and 10 patients harmed due to 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 regularly encountered drug shortages, and a 49-year-old San Francisco cancer patient who spoke to the FDA last month about his struggles with a shortage in his chemotherapy drug.
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