- WASHINGTON (Reuters) - The
U.S. Food and Drug Administration should work more closely with companies
making narcotics and other drugs to make sure they are not abused like
OxyContin was, congressional investigators said on Thursday.
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- The official General Accounting Office report on OxyContin
spreads the blame evenly - noting that the FDA failed to aggressively regulate
the popular painkiller and that its makers pushed too hard in marketing
it.
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- But now, it said, the company, federal and state regulators
were working to get the problem under control and were putting into place
plans that can help prevent such problems in the future.
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- OxyContin was introduced in 1996 and while it contained
high levels of narcotic, it was formulated for time-release and drugmaker
Purdue Pharma said its formulation made it unlikely anyone could abuse
it.
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- But the labeling on the pills clearly told how to circumvent
controls - by crushing the tablets. The drug quickly became a favorite
of narcotics abusers.
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- More than 100 people across the country have died from
abusing OxyContin, according to the Drug Enforcement Administration.
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- At the same time, Purdue was aggressively promoting the
drug to doctors. By 2001 OxyContin, known generically as oxycodone, was
the most prescribed brand-name narcotic for moderate-to-severe pain.
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- The DEA and the Food and Drug Administration have both
expressed concern about how Purdue markets OxyContin and the FDA has acted
twice against the company for violating advertising standards.
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- The GAO, the official investigation arm of Congress,
was asked to sort out what happened.
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- "The active ingredient in OxyContin is twice as
potent as morphine, which may have made it an attractive target for misuse,"
the GAO said it its report released on Thursday.
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- "Further, the original label's safety warning advising
patients not to crush the tablets because of the possible rapid release
of a potentially toxic amount of oxycodone may have inadvertently alerted
abusers to methods for abuse."
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- The drug also became highly available because of its
popularity, the GAO noted in the report, available on the Internet at http://www.gao.gov/cgi-bin/getrpt?GAO-04-110.
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- And the FDA did not work hard to see the promotional
videos Purdue used to market the drug - some of which were later recalled
and destroyed by the company.
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- The GAO said federal and state agencies were working
with Purdue to address the problem. For instance, the FDA approved a revised
label in 2001 that stresses the dangers of OxyContin. It also worked with
Purdue on a plan to identify potential abusers and to prevent illicit sales
and use.
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- "Purdue has also taken disciplinary action against
its sales representatives who improperly promoted OxyContin and has referred
physicians who were suspected of misprescribing OxyContin to the appropriate
authorities," the GAO said.
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- The GAO said it had suggested to the FDA that when approving
future drugs that could be abused, the agency encourage the makers to come
up with a plan for preventing abuse.
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- But it said only 15 states had prescription drug monitoring
programs and most were not comprehensive.
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- The GAO said the FDA and Purdue mostly agreed with its
findings but noted that Purdue also laid some blame on the media, which
publicized how to crush and abuse the pills.
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- "We are firmly committed to combating the abuse
of our product, and we appreciate the GAO's acknowledgment of our efforts
in this regard," Howard Udell, Purdue's chief legal officer, said
in a statement.
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