Two important pieces of news from our friends at BioCentury:
Hamburg opposes separate safety reviews
FDA Commissioner Margaret Hamburg told BioCentury she opposes separating postmarket safety oversight from new drug reviews, a policy Rep. Rosa DeLauro (D-Conn.) and Sen. Chuck Grassley (R-Iowa) are promoting. DeLauro recently announced plans to attach a report instructing FDA to create an independent postmarket drug safety office to an appropriations bill.
"We need to strengthen the integration of safety and efficacy throughout the lifecycle of medical products," Hamburg said. "It would be a mistake to further separate and stovepipe safety and efficacy." Hamburg said she is considering organizational changes to better integrate safety and efficacy oversight. In addition, she said FDA needs to "strengthen safety science, and that's why I've asked the Institute of Medicine to do a report [on postmarket safety studies], and our Science Board will be undertaking a study about safety science at FDA"
Hamburg supports releasing complete response letters
Releasing information about negative decisions on drug applications could benefit drug developers and advance scientific progress, FDA Commissioner Margaret Hamburg said Tuesday at a conference on drug development. An FDA transparency working group's draft proposals include publicizing redacted versions of complete response and refuse to file letter.
"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," Hamburg said at the meeting, sponsored by Friends of Cancer Research, Ewing Marion Kauffman Foundation, Council for American Medical Innovation and others. Companies might oppose public release of information about rejection of their application, but "those same companies can recognize there are benefits if everyone opens up and does the same,” she said.
Hamburg told BioCentury that disclosures would describe the reasons for a rejection. They also "would obviously speak to the adequacy of data in certain instances, but more significantly, that certain approaches might not be effective or certain kinds of molecular entities have certain toxicities, and that could have relevance beyond a particular application." FDA would not release commercial confidential information "without industry's explicit permission," she said.
Hamburg opposes separate safety reviews
FDA Commissioner Margaret Hamburg told BioCentury she opposes separating postmarket safety oversight from new drug reviews, a policy Rep. Rosa DeLauro (D-Conn.) and Sen. Chuck Grassley (R-Iowa) are promoting. DeLauro recently announced plans to attach a report instructing FDA to create an independent postmarket drug safety office to an appropriations bill.
"We need to strengthen the integration of safety and efficacy throughout the lifecycle of medical products," Hamburg said. "It would be a mistake to further separate and stovepipe safety and efficacy." Hamburg said she is considering organizational changes to better integrate safety and efficacy oversight. In addition, she said FDA needs to "strengthen safety science, and that's why I've asked the Institute of Medicine to do a report [on postmarket safety studies], and our Science Board will be undertaking a study about safety science at FDA"
Hamburg supports releasing complete response letters
Releasing information about negative decisions on drug applications could benefit drug developers and advance scientific progress, FDA Commissioner Margaret Hamburg said Tuesday at a conference on drug development. An FDA transparency working group's draft proposals include publicizing redacted versions of complete response and refuse to file letter.
"We don't publish information when we don't approve a drug as to why we don't approve it, but that information clearly could have broad value," Hamburg said at the meeting, sponsored by Friends of Cancer Research, Ewing Marion Kauffman Foundation, Council for American Medical Innovation and others. Companies might oppose public release of information about rejection of their application, but "those same companies can recognize there are benefits if everyone opens up and does the same,” she said.
Hamburg told BioCentury that disclosures would describe the reasons for a rejection. They also "would obviously speak to the adequacy of data in certain instances, but more significantly, that certain approaches might not be effective or certain kinds of molecular entities have certain toxicities, and that could have relevance beyond a particular application." FDA would not release commercial confidential information "without industry's explicit permission," she said.
