At a town hall meeting in Atlanta today, FDA officials said they are taking several steps to address public perception that they are not tending well to drug safety. By building in more
time for reviewers to mull approval decisions and to communicate in a more timely
fashion with drug firms about labeling and postmarketing commitments, the agency
hopes fewer safety issues will slip through the cracks.
“We are really embarking on a new era of transparency within
the review team,” said Sandra Kweeder,
deputy director of FDA’s Office of New Drugs. “What you [companies] will
likely see from this is earlier communication from us to you about potential
problems with a [new drug application].”
Changes in review
timelines also will extend the final decision period for reviewers. “One
of the biggest things that…we were not doing well was leaving enough time at
the end of a review process for the person who has to sign on the dotted
line…to really think about the decision,” Kweeder said.
She said the
agency plans to ask staffers to phase in the new timelines and processes gradually,
beginning in fiscal year 2008, which starts this fall.
As far as creating a separate drug safety office—an idea the
agency has resisted—Kweeder acknowledged that “we haven’t done as good a job as
we could to integrate the work” but that new processes address the increased
workload that comes with monitoring safety reports. In every division of the
Office of New Drugs, a senior person has been assigned the role of associate
director for safety, whose job it is to monitor such issues, and a new safety issue
tracking system is being used.
Changes are in the works even as legislation affecting the
agency’s power to require postmarketing studies is being debated on Capitol
Hill. The House is moving closer to reauthorizing the user-fee legislation,
which would raise the amount drug companies usually pay to speed premarket
review plus bring in millions more to fund issues related to postmarketing
review. The House bill would also give the FDA more authority to decide which
drugs need to be monitored following approval. Last month the Senate passed a bill
that includes three years of annual safety reviews.
Enhanced authority would give the agency some additional
tools to beef up drug safety. Republicans and Democrats have pilloried the FDA
over its handling of safety issues involving drugs like Merck’s Vioxx and just
recently GlaxoSmithKline’s diabetes drug Avandia. After they were approved,
both were linked to an increased risk of heart attacks.
At the town hall meeting, hosted by the Drug Information
Association at its annual gathering, officials addressed the future of agency communication as well as
how the increased scrutiny from the media and lawmakers has altered its focus.
“One of the things you read about in the papers all the time
is that [the FDA doesn’t] care about safety, just effectiveness,” said Bob
Temple, director, Office of Medical Policy, Office of Drug Evaluation. “We may
or may not be as successful in identifying safety issues or characterizing them
but…people in the review divisions…care deeply, violently about the safety things
that turn up later….They would be unbelievably embarrassed if they were thought
to be asleep at the switch.”