FDA hopes better communication can lessen safety slip-ups

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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.”

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