authority and better enforcement tools, including fines, injunctions, and withdrawals), Dr. Haffner suggested that if the FDA is given more authority, there must be a clear description of that authority, how it is to be exercised, and how it can and should be exercised with input from other stakeholders. Moreover, that authority should be used only outside the political arena. While industry benefits from a strong and scientifically based FDA, and while the FDA should have the authority to withdraw a product, Dr. Haffner emphasized that this must be done with care and only under rare circumstances.

The IOM report recommended that the FDA have increased authority to restrict drug distribution (Recommendation 5.1). With respect to Recommendation 5.1.a—conditional distribution based on agency-initiated changes in drug labels—Dr. Haffner argued that imposition of this condition (1) must include dialogue with industry, (2) should be a transparent process involving communication of risk to patients, and (3) should involve only thoughtful changes that meet the perceived safety need. With respect to Recommendation 5.1.d—distribution restricted to certain facilities, pharmacists, or physicians with special training or experience—Dr. Haffner noted that to some extent, the FDA already has this authority and uses it. Once again, however, she emphasized that such restrictions should be used only in the appropriate circumstances, that patient access should be taken into account, and that patients should be properly accommodated when necessary.



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