Indiana Representative Pushes Bill on Drug Shortages
Earlier this week, Representatives Larry Bucshon (R-IN) AND John Carney (D-DE) and introduced H.R.3839, the "Drug Shortage Prevention Act," which, according to its sponsors, is intended to bring "more efficiency to the manufacturing and distribution processes" and to require "FDA to take action to prevent drug shortage problems before they begin impacting patients."
The bill would require FDA to develop and make publicly available two lists of products: (1) a National Critical Drug List; and (2) a National Critical Drug Shortage List.
The bill would require the HHS Secretary to conduct a study on the feasibility of creating a national contingency plan to address critical drug shortages, including the possible creation of a Federal stockpile of critical drugs or the expansion of an existing Federal stockpile of drugs to include critical drugs for such purpose.
The Drug Shortage Prevention Act also requires FDA to notify the DEA of any critical drug on the critical drug shortage list that is a controlled substance, and permits the Attorney General to allow for the determination of whether or not it is appropriate to increase a controlled substance quota to address the shortage.