By Blair Childs, Senior Vice President of Public Affairs, Premier
We applaud FDA’s proactive leadership to promote competitive markets by calling out manufacturers that abuse well-intentioned programs like the Risk Evaluation and Mitigation Strategy (REMS) to block new market entrants. While Commissioner Scott Gottlieb deserves great credit for shining a light on this problem and for taking important preliminary actions, we believe FDA’s authority only goes so far. We also need Congress to enact the CREATES Act (S.974/H.R.2212) that will create a legally enforceable, clear process for generic manufactures to obtain product samples.
We also support the FDA’s willingness to review and examine its policies and authorities to help prevent drug shortages. Premier is intensely focused on reducing and managing drug shortages overall, and we have made a number of recommendations to FDA on how to better managing them. From advocating for the DEA to address the shortage of injectable narcotic medications to assisting hospitals obtain critical IV saline solution products after key suppliers were ravaged by hurricanes in 2017, Premier has been a crucial player in preventing shortages from escalating and impacting patient care. We are encouraged by and supportive of FDA’s willingness to explore an improved and more dynamic procedure for advanced notification of impending shortages, as well as the potential for new authorities that could be used to prevent or mitigate ongoing drug shortages that have serious implications for public health.
-By Blair Childs, Senior Vice President of Public Affairs, Premier