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 moretime for reviewers to mull approval decisions and to communicate in a more timelyfashion with drug firms about labeling and postmarketing commitments, the agencyhopes fewer safety issues will slip through the cracks.
“We are really embarking on a new era of transparency withinthe review team,” said Sandra Kweeder,deputy director of FDA’s Office of New Drugs. “What you [companies] willlikely see from this is earlier communication from us to you about potentialproblems with a [new drug application].”
Changes in reviewtimelines also will extend the final decision period for reviewers. “Oneof the biggest things that…we were not doing well was leaving enough time atthe end of a review process for the person who has to sign on the dottedline…to really think about the decision,” Kweeder said.
She said theagency 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 theagency has resisted—Kweeder acknowledged that “we haven’t done as good a job aswe could to integrate the work” but that new processes address the increasedworkload that comes with monitoring safety reports. In every division of theOffice of New Drugs, a senior person has been assigned the role of associatedirector for safety, whose job it is to monitor such issues, and a new safety issuetracking system is being used.
Changes are in the works even as legislation affecting theagency’s power to require postmarketing studies is being debated on CapitolHill. The House is moving closer to reauthorizing the user-fee legislation,which would raise the amount drug companies usually pay to speed premarketreview plus bring in millions more to fund issues related to postmarketingreview. The House bill would also give the FDA more authority to decide whichdrugs need to be monitored following approval. Last month the Senate passed a billthat includes three years of annual safety reviews.
Enhanced authority would give the agency some additionaltools to beef up drug safety. Republicans and Democrats have pilloried the FDAover its handling of safety issues involving drugs like Merck’s Vioxx and justrecently 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 InformationAssociation at its annual gathering, officials addressed the future of agency communication as well ashow the increased scrutiny from the media and lawmakers has altered its focus.
“One of the things you read about in the papers all the timeis that [the FDA doesn’t] care about safety, just effectiveness,” said BobTemple, director, Office of Medical Policy, Office of Drug Evaluation. “We mayor may not be as successful in identifying safety issues or characterizing thembut…people in the review divisions…care deeply, violently about the safety thingsthat turn up later….They would be unbelievably embarrassed if they were thoughtto be asleep at the switch.”
