House Introduces Bill to Expedite FDA Drug Review

March 2012, Vol 3, No 2 - FDA Approvals, News & Updates


A new House bill—the Drug Shortage Prevention Act (H.R. 3839)— received bipartisan support to expedite the FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply. This legislation includes the following short-term fixes to the drug shortages:

  • Requiring the FDA to identify drugs that are vulnerable to shortages and mandate expedited review and approval; the FDA would be required to expedite review of changes to manufacturing processes of drugs in shortage, and expedite approval of an alternative supplier
  • The FDA will notify distributors of an imminent critical drug shortage, while allowing the agency to withhold notification to a distributor determined to be stockpiling, price gouging, or engaging in other illegal activities related to distribution of a drug in shortage; furthermore, the FDA would have to develop a system to notify the public when a drug is added to the drug shortage list
  • Mandating closer communications between the FDA's regulatory staff and its drug shortage team and communicating any new concern identified about a critical drug, including possible manufacturing problems, within 1 business day to the FDA drug shortage office, and within 5 business days to manufacturers
  • The Attorney General will determine whether it is appropriate to increase ≥1 DEA quotas to address a drug shortage, and mandate that the DEA and FDA increase the quota for controlled substances on the shortage list
  • The Secretary of Health and Human Services will determine the logistics associated with creating a national contingency plan in the event of a critical drug shortage, including the creation of a national stockpile for these drugs.

(January 31, 2012)