Whatever the outcome, the big picture is clear: We are now on the brink of significant drug and biologic regulatory changes. Companies should expect a much more significant oversight of the systemic use of their drug products, with constant reevaluation of critical drug safety issues. They should also anticipate the increasing use of data mining—by FDA and third parties—to engender what will essentially be an "open source" drug safety dialogue with the scientific and medical community. The sponsor–FDA dialogue—and any resolutions, whether actual or notional—of drug safety issues will continue to be questioned even if the perception of FDA grows stronger after PDUFA IV implementation. Companies should also anticipate enforcement activities testing the scope and impact of new PDUFA IV authorities. Given the stakes, although the final details remain to be written, manufacturers should plan now to help shape the implementation of PDUFA IV.

Daniel Kracov is partner and head, FDA and Healthcare Practice Group, Arnold & Porter LLP. He can be reached at daniel_kracov@aporter.com
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