* Agency has required 385 postmarket studies since 2008
* New safety information led to changed labels 65 times
By Debra Sherman
ATLANTA, April 21 The U.S. Food and Drug
Administration said on Saturday it now spends as much effort and
resources on surveilling a drug after it is approved as it does
in the pre-approval process.
The FDA was responding to critics who say the agency is
toothless when it comes to tracking the safety of drugs already
on the market, when industry funds that supported pre-approval
reviews tend to dry up.
"We think we've really balanced this," Dr. Janet Woodcock,
director of the agency's Center for Drug Evaluation and
Research, told reporters attending the Association of Healthcare
Journalist meeting in Atlanta.
In a report released on Saturday, the FDA says it has
required companies to do 385 post-market studies since 2008, and
to change the label based on new safety information 65 times.
Before 2008 the FDA could not compel label changes or
require additional safety trials and had to rely on voluntary
action from drugmakers, she said.
The FDA's focus on post-market drug safety comes after the
agency was sharply criticized as being slow to respond to drug
side effects, notably Vioxx, a painkiller that Merck & Co Inc
pulled five years after approval because of a link to
heart attacks and strokes.
A 2006 report from the Institute of Medicine, an independent
research body that advises the government on scientific matters,
found the FDA needed to do more to police the safety of
medicines after they reach the market.
Congress later gave the FDA more power to oversee drugs
after approval, such as ordering companies to change their
labels or conduct additional safety trials, and fining them if
they fail to do so.
But critics question how often the agency actually follows
through on penalties.
In 2008 the FDA also launched Sentinel, a computer tracking
system designed to help identify problems with drugs and medical
devices already on the market by searching various databases for
possible side effects - rather than just relying on voluntary
reports from companies and patients.
The FDA said it used the system to see if there were
negative drug interactions for Chantix, the smoking cessation
drug manufactured by Pfizer Inc, but did not find any.
Last November U.S. researchers said Chantix carried too many
risks and should only be tried when other treatments fail.
The findings, which Pfizer said were flawed, contradicted
two studies released in October by the FDA that showed Chantix
(sold as Champix outside the United States) did not increase the
risk of being hospitalized for psychiatric problems such as
The agency at the time acknowledged those studies were
flawed because they were too small to identify rare events and
captured only cases severe enough to land people in the
Woodcock could not immediately provide examples of where
Sentinel alerted the agency to safety information they had not
been aware of before.