Saturday, December 1, 2007

The FDA Considers Giving Away the Shop

The FDA is considering allowing pharmaceutical companies to advertise off label uses of drugs by sending articles to physicians. The proposed new regulations would sell-out on FDA responsibilities and further skew the ethical landscape for drug use in the U.S.

I can’t believe the proposed change will go through. The ethical quality of our health care system depends on whether we can achieve a balanced deliberative process to consider the multiple values involved in steering the system. We depend on the FDA to play a role in checking Pharma’s marketing juggernaut.

It is right and proper for drug companies to market their products vigorously, but only within the boundaries created by law, regulation, and ethics. The FDA has slapped multiple fines on pharmaceutical companies for illegally marketing off label uses for their products, but these fines are treated as an ordinary cost of doing business.

Now the FDA proposes to lower the bar for marketing of off label prescribing. I doubt that I am alone in assuming that the FDA and its administrative masters are being bought off.

Marketing isn’t an evil activity. But for the FDA to abdicate its responsibilities to the public is.

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