Under growing pressure from Republican lawmakers and drug manufacturers to speed up and de-risk the approval process, FDA Commissioner Margaret Hamburg has been signaling a willingness to relax the agency's conflict-of-interest rules in order to ensure it has the experts it needs for its high-profile advisory committees.
Speaking to Public Citizen, one of the fiercest critics of the pharma industry, Hamburg says she's interested in loosening the three-year-old set of rules governing the financial ties of experts and biopharma companies. But she also adamantly maintained that the FDA has received a bum rap for being slow, saying that the stats demonstrate that the agency has been faster than its counterparts around the globe.
"We have to be sure that FDA has subject-matter experts that we need for our important decision making," Hamburg told the unreceptive crowd, according to a report in Bloomberg. She said that the FDA must "prevent inappropriate influence or distortion of information" that could compromise a review, adding that researchers as well as patient advocates have voiced "valid concerns" that demand a review of the rules.
Bloomberg's story emphasizes that critics of the FDA--particularly Republicans in Congress alongside pharma companies--have complained about the slow-moving approval process, claiming that regulators are making unanticipated demands for new safety data. Of course, it would be hard to find a single example of a drug developer presented with a demand for a new trial which didn't feel it had been completely blindsided--even after regulators clearly began to ratchet up the bar on safety.
MedPage notes in its coverage of Hamburg that much of the criticism leveled at the agency has been directed at regulators charged with reviewing devices, with heavy turnover in the staff of the Center for Devices and Radiological Health. And Public Citizen's Sidney Wolfe offered some scathing criticism of Janet Woodcock, claiming that the head of CDER was often far slower than regulators in other countries when it came to pulling unsafe drugs from the marketplace.
- read the story from Bloomberg
- and see the report from MedPage