Wednesday, December 10, 2008

Should a doctor in the UK be warned a year earlier for a dangerous drug than a doctor in the US?

Of course not. But that is exactly what happens today, and vice versa, because of provincialism at regulatory authorities in both US and Europe.

The FDA should work together with the European regulatory authority, EMEA, and could inform US doctors when a major warning goes out in Europe, if the FDA is not yet ready to issue the same warning, and let them know what the FDA's schedule is. At a minimum this would keep US doctors informed. And it doesn't cost more than printing the letter.

It is time for change at the FDA and to start protecting the American public.

Another academic as FDA Commissioner won't create change. Doing the same thing and expecting a different result is the definition of insanity.

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