Expert conflict rule: FDA officials disagree with pharmaceutical industry critics

Source: the impact of the shortage of drug experts in 2012-02-06 of the China Council for the promotion of drugs on the review process of the FDA expert panel is an issue under debate in the biopharmaceutical industry However, anyone who expects the FDA to be willing to change its conflict of interest rules - isolating stakeholders - will not be supported by FDA director Margaret Hamburg At this week's congressional hearing, Margaret Hamburg made it clear that the agency does not support any new legislative initiatives to ease the conflict of interest rules that have been in place for four years, despite calls from supporters that change would significantly reduce approval time and improve industrial innovation The FDA director said they have enough immunity available if the agency thinks it needs more panel members According to Reuters, Margaret Hamburg told the House Committee, "so far we have not broken the upper limit of the exemption clause" and "we currently do not see the professional areas that need to be amended by legislation" Patient advocacy groups may support this position But it is hard for many people on the side of drug development to accept, especially critics who often ridicule the FDA as an unresponsive bureaucracy "We believe it is necessary to improve the procedures of the Advisory Committee, especially in areas where there is a lack of expertise," said Gino Germano, President of Pfizer's professional care and oncology division, Reuters reported Due to differences of opinion, the problem may not be solved soon Original link: http://www.firecebiotech.com/story/fda-commit-counters-industry-criticism-expert-conflict-rules/2012-02-03