NABP Comments on FDA Drug Shortages Strategic Plan Stress Ensuring Safety When Non-Approved Drugs Are Used

To protect the public health, Food and Drug Administration (FDA) should carefully consider using the exercise of enforcement discretion during drug shortages, urges NABP. The statement was part of the Association’s comments submitted to FDA in response to the establishment of the FDA Drug Shortages Task Force and Strategic Plan. In the comments, NABP also requested that FDA clarify the current meaning of manufacturer registration and require that such registration be reserved for entities possessing an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and adhering to current Good Manufacturing Practices (cGMPs). NABP indicated that “when FDA-approved sterile drugs are in shortage, an exercise of enforcement discretion by FDA that subsequently allows for non-FDA approved, prepared sterile dugs to be used in place of FDA-approved sterile drugs should be carefully considered, as the solution may be more dangerous to patients than the shortage itself.” NABP suggested using a benefit-risk assessment, considering three questions, in such cases. The benefit-risk assessment should include considering whether an alternative approved drug is available, whether the drug in shortage can be safely prepared outside of cGMPs, and whether doing so will cause manufacturers holding an NDA or ANDA for the drug to discontinue production. NABP also emphasized that when it is determined that the use of unapproved drugs is the only solution, product preparation requirements and enforcement procedures should be put into place, and close coordination among FDA and state pharmacy and medical boards should be initiated. Further, the Association believes that in such cases, communication strategies should be implemented to inform prescribers, pharmacists, payers, and patients about the differences in products and risks associated with non-approved drug products. The NABP comments (PDF) submitted to FDA are available in the Newsroom of the NABP Web site.