The FDA Amendments Act of 2007: Assessing Its Effects a Decade Later

From the New England Journal of Medicine.

By Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH; Ameet Sarpatwari, JD, PhD.

SUMMARY: This NEJM Perspective by Avorn, Kesselheim, and Sarpatwari evaluates the FDA Amendments Act of 2007 (FDAAA) a decade after its enactment. The authors open by situating the FDAAA within the long history of US drug regulation, which has been shaped by crises: Progressive-era concerns about patent medicines led to the 1906 Pure Food and Drug Act; the deaths of more than 100 patients from a toxic sulfanilamide formulation in 1937 led to pre-market safety requirements. The FDAAA itself was driven in significant part by the Vioxx crisis. The piece evaluates whether the Act's key provisions — particularly around post-market safety surveillance, Risk Evaluation and Mitigation Strategies, and comparative effectiveness — have achieved their intended goals a decade on.

BACKGROUND: The FDA Amendments Act of 2007 was enacted in the wake of major drug safety crises, particularly the withdrawal of rofecoxib (Vioxx) after it was found to double the risk of myocardial infarction and stroke in over 20 million patients.

KEY FINDINGS: The authors assess a decade of experience with FDAAA's provisions on post-market safety surveillance, Risk Evaluation and Mitigation Strategies, and related requirements for drug manufacturers.

IMPLICATIONS: A decade-long assessment of the FDAAA offers lessons for how Congress and the FDA can design post-market safety requirements that are both effective in protecting patients and administratively workable.