House Democrats tacked on two riders to the Food and Drug Administration appropriations bill this week that would lessen pharmaceutical industry influence at that critical agency. Amazingly, the Republican majority, which usually sides with the industry, let them through.
Rep. Rosa DeLauro (D-Conn.)’s amendment gave the FDA the authority to pull a drug from the market if its manufacturer didn’t follow through on its promises to conduct post-approval clinical trials confirming its safety. Recent reports from FDA showed that about two-thirds of such promises, which are made at the time of approval, never get fulfilled.
A second rider came from Rep. Maurice Hinchey (D-NY), who is pushing for a thorough overhaul of the agency that regulates about a quarter of the U.S. economy. His bill would prohibit the FDA from using physicians with financial ties to drug or medical device manufacturers on its 31 outside advisory panels. Over 110 waivers of those conflicts-of-interest have been issued in recent months, according to Hinchey’s press release. The FDA doesn’t turn to outside panels for every decision it makes, but it does when it has real doubts about the new drug being considered for approval. And it usually followed these panels’ advice.
Does it make any sense to allow physicians with financial ties to the maker — or one of its rivals — to sit on the jury guiding the decision?
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While I think this sort of reform is needed, I have my doubts about it getting through both houses of congress. I am
surprised that Republicans went along but I am sure there are reasons why even if we don’t understand it. I doubt it will even pass the House if it gets floor vote.
Ed Vawter
QD Information Services LLC
website: http://www.qdinformation.com
blog: http://www.qdinformation.com/qdisblog/
this is a hard one.
it makes good sense to limit decision making experts to those without a vested interest in the outcome.
but many if not most of the best researchers are currently tied to private company funded research.
That’s where the research money is after our government cut back on NIH (National Institute of Health) and NIMH (National Institue of Mental Health) funded research, the neutral research.
maybe we need something like the supreme court judges bowing out on cases with personal or professional type vested interest or prejudice. FDA decision makers and experts might have to be free of ties to a specific company or competator for a certain type of medicine or device.
that way we can keep good researchers invovled, just limited by specific potential biases.