Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage

By Kurt R. Karst –      
 
Earlier this week, Representatives John Carney (D-DE) and Larry Bucshon (R-IN) 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 is the latest action plan to address the increasing problem of drug shortages.  Last year saw the introduction of the “Preserving Access to Life-Saving Medications Act of 2011” (S. 296, H.R. 2245), an Executive Order from President Obama (see our previous post here), and an interim final rule from FDA to make better use of its existing shortage-related authority under the FDC Act among other things (see our previous post here).  The topic of drug shortages is expected to be raised next week at the House Energy and Commerce Committee hearing on generic drug and biosimilar user fees.

H.R.3839 would amend the FDC Act to add § 506D to 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 does not actually define the terms “critical drug” or “critical drug shortage.”  Rather, FDA would be required to solicit stakeholder input through a public hearing or public docket to define the terms.  The bill does state what information should be included in each list, such as (for the shortage list) an indication of the severity of the shortage, the reason for the shortage, and identification of alternative therapies.

FDA would be required to expedite its review of NDAs and ANDAs seeking approval of a “critical drug” and any request by the sponsor of a critical drug to approve a change to the manufacturing process, manufacturing facility, or to add an alternate active pharmaceutical ingredient supplier.  “In expediting the review of applications and requests . . . [FDA] shall not unnecessarily delay the review of applications and requests for drugs and biological products that are not critical drugs.”  In addition, 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.