Drug Safety Forecast: Greater Understanding Could Signal Fewer Withdrawals
Efforts to foster innovation may have been the major theme for FDA in 2013, with new and expanded programs to expedite review of drugs for unmet medical needs dominating headlines, but senior agency officials also describe continued advances on the safety side of the regulatory equation.
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FDA rejected two of the sponsor’s labeling proposals because they failed to adequately address safety issues seen in the PACE trial. Ariad apparently preferred to quantify in labeling only treatment-emergent adverse events that investigators attributed to ponatinib – an approach FDA disdains for single-arm studies.
Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.