US FDA review and regulation of preventive vaccines for infectious disease indications: impact of the FDA Amendments Act 2007

Abstract

Vaccines for prevention or treatment of infectious diseases are biological products that are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research of the US FDA. The legal framework for the regulation of vaccines derives primarily from Section 351 of the Public Health Service Act and from certain sections of the Federal Food, Drug and Cosmetic Act (FFD & C Act). The FDA Amendments Act of 2007 (FDAAA 2007) includes extensive modifications to the FFD & C Act. This article provides an overview of the review process for preventive vaccines and highlights applicable statutory provisions. In addition, this article will discuss changes in the pre-and post-licensure evaluation process for preventive and therapeutic infectious disease vaccines since implementation of the FDAAA 2007.

Keywords::

• enhanced authorities
• FDAAA 2007
• Federal Food, Drug & Cosmetic Act
• infectious disease
• managed review process
• Pediatric Research Equity Act
• postmarketing drug safety
• US FDA
• vaccine
• vaccine approval process

Acknowledgement

The author would like to thank K Midthun, T Finn, L McVittie, M Hess and D Hithe for their critical review and assistance with preparation of this manuscript.

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.