After-market drug regulation: An essential element of public trust in innovation

Abstract

Newly marketed drugs present unavoidable risks, no matter how diligent the level of pre-market review. Numerous adverse drug events attest to the need for post-market vigilance. However, the Food and Drug Administration monitors drugs with considerably less rigor after launch than before. This burdens both public health and public trust in the safety of new medicines. As new technologies such as genomics guide a larger share of drug development, the issue will become more acute. Most reform proposals present considerable logistical challenges. A promising alternative is to harness existing managed care databases to search for drug effects.

Citation

Field, R.I. (2007), "After-market drug regulation: An essential element of public trust in innovation", Farquhar, I., Summers, K.H. and Sorkin, A. (Ed.) The Value of Innovation: Impact on Health, Life Quality, Safety, and Regulatory Research (Research in Human Capital and Development, Vol. 16), Emerald Group Publishing Limited, Leeds, pp. 3-27. https://doi.org/10.1016/S0194-3960(08)16001-2