WASHINGTON (AP) — President Barack Obama is
directing the Food and Drug Administration to take steps to reduce drug
shortages, an escalating problem that has endangered patients and raised the
possibility of price gouging.
Patient deaths have been blamed on the shortages,
which tend to affect cancer drugs, anesthetics, drugs used in emergency
medicine, and electrolytes needed for intravenous feeding. Hospitals have been
forced to buy from secondary suppliers at huge markups. Surgeries and cancer
treatments have been delayed.
A White House official said Obama planned to sign
an executive order Monday instructing the FDA to take action in three areas:
broadening its reporting of potential drug shortages; accelerating reviews of
applications to change production of drugs facing potential shortages; and
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 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 reported 178 drug shortages last year, and
the agency says it continues to see an increase 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 newer 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 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 told an FDA workshop last month
how he grappled with a shortage in his chemotherapy drug.
Copyright
2011 The Associated Press.
(AP
Photo/Pablo Martinez Monsivais/file)
