myrl

Thanks to one of our readers for sending the following article...Myrl


Dec. 11, 2004, 8:49PM
http://www.chron.com/cs/CDA/ssistory.mpl/nation/2942064

Critics: FDA efforts to monitor drugs lacking
Ill effects among patients not found because of deal made with makers,
some maintain
By GARDINER HARRIS
New York Times

Dozens of former and current Food and Drug Administration officials,
outside scientists and advocates for patients say that the agency's
efforts to monitor the ill effects of drugs that are on the market are
a shadow of what they should be because the White House and Congress
forced a shotgun marriage between the agency and industry years ago for
the rich dowry that industry offered.


Under the 1992 agreement, the industry pledged to give the agency
millions - this year, $200 million - but only if the agency spent a
specified level of money on new drug approvals.

As congressional support sank since then, the agency has cut everything
else but new drug reviews. In the past 11 years, spending on the
reviews has increased from about half to more than four-fifths of the
agency drug center's budget.

Among the priorities that took the worst hit was ensuring the safety of
the drugs that patients are already taking. Drug companies test their
products in people before they are approved, but sometimes potentially
serious problems arise only when they are being used by millions of
people. The FDA cannot require drug makers to undertake new safety
tests once a drug is approved, so tracking the safety of drugs already
on the market is the agency's responsibility.

But as a result of the agency shifting its resources, almost everyone
now agrees that its mechanisms for uncovering the dangers of drugs
after they have been approved are woefully inadequate.

The FDA's present safety monitoring system "is not good for determining
if a drug increases the rate of a side effect already common in the
population," said Dr. Janet Wood****, acting deputy commissioner for
operations at the agency.