collaboratively in crisis situations and then informing the public about those decisions.

Dr. Goldman’s suggestion that more judgment be put in the materials that the FDA gives to consumers prompted a comment that this was very different from Mr. Hutt’s argument (see Section 4) that patients be given the facts only and be allowed to make their own judgments. It was noted that this is an excellent demonstration of the fact that very reasonable people have diametrically opposed views about what the FDA should do on any given matter.

A comment was made about how much of the workshop discussion focused on academics, industry and consumers, but that the entire FDA regulation process relies on the prescribing physician as a critical “learned intermediary.” The complete absence of participation by such groups in the FDA regulatory process is striking. While, in the past, efforts have been made to build relationships with medical professional organizations, budgetary constraints have eliminated that component from the agency. Little has been done to reestablish those relationships and have had varying degrees of success in trying to partner with them. Dr. Goldman noted that this is why she mentioned how difficult it is for physicians to understand some drug labels. She agreed that they are “out of the loop.” Dr. Leiden agreed and noted that “opinion leaders” practice in highly controlled academic medical centers where drugs are used very differently than they are in the “real world.” We need to consider the knowledge and input of practitioners who are regularly seeing patients and prescribing drugs.



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