safety. To that end, the website MedWatch: The FDA Safety Information and Adverse Event Reporting Program ( now includes information on new package inserts and labels, recent safety information and alerts, quarterly reports on potential safety issues identified by using the Adverse Event Reporting System database, and links to other FDA-approved safety information. FDA has recently taken advantage of new technology by making electronic subscriptions available to MedWatch via e-newsletters, safety alerts, and Twitter (FDA, 2012).

Under FDAAA, FDA is also required to include on its website the approval package, which contains FDA staff reviews of a drug with proprietary information redacted, for any new molecular entity. For drugs that are not new molecular entities, it is required to provide the same material upon request. That approval information is now posted for each drug on FDA’s website at Drugs@FDA.17 As suggested in the 2007 Institute of Medicine report, FDAAA called for FDA to form an Advisory Committee on Risk Communication,18 which was established in 2008. The role of the advisory committee is to improve how information on drugs and drug safety is communicated to health care professionals and the public.19


Carpenter, D. 2010. The other side of the gate: Reputation, power, and post-market regulation. In Reputation and power. Organizational image and pharmaceutical regulation at the FDA. Cambridge, NY: Princeton University Press.

FDA (US Food and Drug Administration). 2009a. IOM recommendations: FDA actions update. (accessed March 20, 2012).

FDA. 2009b. FDAAA implementation—highlights two years after enactment. (accessed March 20, 2012).

FDA. 2012. MedWatch: The FDA safety information and adverse event reporting program. (accessed August 17, 2011).


17Drugs@FDA is located at (accessed on February 13, 2012).

1821 USC § 360bbb–6 (2010).

1921 USC § 355(r)(6) (2010).

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