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发帖数: 2273 | 1 Between 2006 and 2010, drug shortages increased by more than 200%, according
to a Government Accountability Office report released Thursday. There were
a record 196 shortages last year, and even more are expected in 2012.
“These shortages often force Americans to go without treatment,” Senator
Tom Harkin said.
Renee Mosier is one of those patients who has been forced to forgo treatment
and look for alternatives. The 61-year-old was first diagnosed in 2006 with
ovarian cancer. After several successful surgeries and chemotherapy
treatments, the cancer came back this past June.
Her doctor suggested a chemo regimen that included Doxil, one of the most
successful drugs to help keep ovarian cancer at bay. The only problem? Doxil
wasn’t available. It is one of the drugs on the drug shortage list, and
has not been available for several months. On average, the GAO report found
that most shortages last more than 9 months.
For Mosier, it’s not just about waiting for the drug. “It’s a life and
death thing,” she says.
More than half of the drugs of the shortage list are considered critical,
meaning there are no other alternatives for them. Doxil has no generic
equivalent. The drugs most often in short-supply included anesthetics and
oncological drugs.
The report pointed to manufacturing issues, such as shutdowns, and technical
difficulties as being some of the biggest reasons for the drug shortages.
In addition, many drugs, like Doxil, are very difficult to technically
replicate. So, once there is a shortage, it is almost impossible for another
manufacturer to start producing a similar drug to relieve the shortage.
The report suggested that the Food and Drug Administration could better
respond to the shortages if manufacturers were required to report to the FDA
of potential shortages, allowing the FDA to find alternatives to deal with
the potential shortage. Currently there is no such legislation requiring
drug manufacturers to do so, and the FDA most frequently finds out about
shortages from doctors and patients.
In addition, the FDA does not maintain its own drug shortage data, which
would better enable the FDA to monitor trends.
A result of the drug shortage has been price gouging and the creation of a
“grey market” for hard-to-find drugs. “Aggressive measures are necessary
to crack down on anti-consumer practices promoted by so-called 'gray markets
' that inflate prices, creating a public health menace," Senator Richard
Blumenthal said. "There should be zero tolerance for profiteering or price
gouging in these essential drug markets.”
President Obama did sign an executive order this past October requiring the
FDA to expedite regulatory reviews of drug manufacturers and investigate
price gouging.
Building on the Executive Order in October, the White House also announced
on Thursday that they will immediately begin requiring some drug
manufacturers to report production interruptions to the FDA. The
manufacturers that have to report to the FDA are those drug manufacturers
that have no generic equivalent and are critical to maintaining life.
In addition, there are currently two bills before Congress that address the
issue. But while Congress tries to create some sort of solutions, patients
like Renee Mosier are forced to wait.
“You just don’t expect it to happen here." |
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