OT: FDA Fails to Follow Up on Unproven Drugs

http://www.time.com/time/health/article/0,8599,1932236,00.html

FDA Fails to Follow Up on Unproven Drugs
By AP / MATTHEW PERRONE Monday, Oct. 26, 2009

The Food and Drug Administration has allowed drugs for cancer and
other diseases to stay on the market even when follow-up studies
showed they didn't extend patients' lives, say congressional
investigators.

A report due out Monday from the Government Accountability Office also
shows that the FDA has never pulled a drug off the market due to a
lack of required follow-up about its actual benefits — even when such
information is more than a decade overdue.

When pressed about that policy, agency officials said they have no
plans to get more aggressive.

The GAO says the FDA should do more to track whether drugs approved
based on preliminary results actually have lived up to their promise.

The FDA responded that the report paints an overly negative picture of
its so-called "accelerated approval" program, which is only used to
approve drugs for the most serious diseases.

"Millions of patients with serious or life-threatening illnesses have
had earlier access to new safe and effective treatments," thanks to
the program, the FDA said in its response to the report.

In 1992, the FDA began speeding up the approval of novel drugs based
on so-called surrogate endpoints, or laboratory measures that suggest
the drug will make real improvements in patient health. HIV drugs, for
example, are cleared based on their virus-lowering power, a predictor
of increased survival.

Drugmakers favor the program because it helps them get products to
market sooner, without conducting long-term patient studies that can
take years and cost hundreds of millions of dollars. A condition of
quicker approvals is that drugmakers conduct follow-up studies to show
the drug's benefits actually panned out.

But the GAO report, a copy of which was obtained by The Associated
Press, identified several drugs still on the market that never lived
up to their initial promise. And in the 16 years that the FDA has used
accelerated approval, it has never once pulled a drug off the market
due to missing or unimpressive follow-up data.
...

--
Luke
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