Didn't take long for the new Congress to take aim at pharma

Feb/03/2007 07:18 Filed in: Pharma Business
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Congress is kicking off efforts to pass big reforms of the Food and Drug Administration, and that could produce some bitter pills for the pharmaceutical industry: potentially, tougher safety rules and provisions to reduce the cost of medicines. Tying new reforms to the FDA's budget the Congress wants to give the FDA more enforcement power but the real question is how can this be done without adding another layer of government bureaucracy.


One thing I believe about politicians; they will say anything to posture for the media. Logistics don't matter t them, that's someone else's responsibility. Among the provisions of the new bill is a measure to restructure the FDA to create a Drug Safety Center. This unit would have the power to alter labels (including a black box warning) on approved drugs if ongoing clinical studies suggest that there maybe some safety issues. What concerns me about this whole process of development of "new guidelines" is the fact that the senators who developed these programs did not reach out to the pharma industry leaders to reach a consensus that would benefit both benefit and protect patients. They went off into their own little worlds and developed these proposals without considering the consequences of their actions.

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As this author has said all along there are changes on the horizon for the drug industry but the issues are complex and far reaching. Poll's continue to show that the public is getting fed up with posturing and lip service, they want people to work together to find solutions for all of us. Pharmaceutical companies continue to be targeted by the media and Congress and who can blame them. All we see on TV are commercials with the CEO of Merck telling us how the company is committed to developing great drugs at a time when they are in the headlines with Vioxx litigation or Pfizer talking about innovation in new drug development when they are laying off 10,000 people and have had a major new drug fail in clinical tests.

Again this author believes that the pharmaceutical industry needs to circle the wagons and inform a skeptical public about the expense of developing new drugs and the number of people worldwide who are leading a better quality of life thanks to todays prescription drugs. If the pharma industry does and says nothing than they had better be prepared for the consequences that will, I believe, limit their ability to compete in an increasing competitive marketplace.

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