Editing Food and Drug Administration (section)

===Post-marketing drug safety monitoring===
The widely publicized recall of [[Vioxx]], a [[non-steroidal anti-inflammatory drug]] (NSAID) now estimated to have contributed to fatal [[myocardial infarction|heart attacks]] in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. The FDA approved Vioxx in 1999, and initially hoped it would be safer than previous NSAIDs due to its reduced risk of intestinal tract bleeding. However, a number of pre and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and results from the APPROVe trial in 2004 conclusively demonstrated this.<ref>{{cite journal | vauthors = Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA | title = Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial | journal = The New England Journal of Medicine | volume = 352 | issue = 11 | pages = 1092–1102 | date = March 2005 | pmid = 15713943 | doi = 10.1056/NEJMoa050493 | s2cid = 8161299 | doi-access = free }}</ref>

Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials<ref name="Graham">{{cite web |url=http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf |title=David Graham's 2004 testimony to Congress |access-date=August 30, 2012 |archive-date=September 25, 2012 |archive-url=https://web.archive.org/web/20120925094651/http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf |url-status=live}}&nbsp;{{small|(28.3&nbsp;KB)}} Retrieved August 30, 2012.</ref> for reforms in the FDA's procedures for pre- and post-market drug safety regulation.

In 2006, a [[United States congressional committee|Congressional committee]] was appointed by the [[Institute of Medicine]] to review pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicine medical research, economics, [[biostatistics]], law, public policy, public health, and the allied health professions, as well as current and former executives from the [[drug company|pharmaceutical]], hospital, and [[health insurance]] industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.<ref name = "Henderson_2006">{{Cite web | vauthors = Henderson D |title=Panel: FDA needs more power, funds |work=[[The Boston Globe]] |date=September 23, 2006 | url = http://www.boston.com/business/healthcare/articles/2006/09/23/panel_fda_needs_more_power_funds/ | archive-url = https://web.archive.org/web/20121023223500/http://www.boston.com/business/healthcare/articles/2006/09/23/panel_fda_needs_more_power_funds/ | archive-date = October 23, 2012 }}</ref><ref>{{cite book | chapter-url = http://www.nap.edu/openbook.php?record_id=11750&page=205 | publisher = Books.nap.edu | archive-url = https://web.archive.org/web/20121025132523/http://www.nap.edu/openbook.php?record_id=11750&page=205 | archive-date=October 25, 2012 | chapter = Executive Summary of the 2006 IOM Report | title = The Future of Drug Safety: Promoting and Protecting the Health of the Public | date = 2007 | doi = 10.17226/11750 | isbn = 978-0-309-10304-6 }}</ref> Some of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the [[Food and Drug Administration Amendments Act of 2007]].<ref>{{cite web |url=https://www.fda.gov/oc/initiatives/advance/fdaaa.html |title=Food and Drug Administration Amendments Act (FDAAA) of 2007 |publisher=Food and Drug Administration |access-date=March 14, 2015 |archive-date=May 25, 2009 |archive-url=https://web.archive.org/web/20090525082137/http://www.fda.gov/oc/initiatives/advance/fdaaa.html |url-status=live}}</ref>

As of 2011, Risk Minimization Action Plans (RiskMAPS) have been created to ensure risks of a drug never outweigh the benefits of that drug within the post-marketing period. This program requires that manufacturers design and implement periodic assessments of their programs' effectiveness. The Risk Minimization Action Plans are set in place depending on the overall level of risk a prescription drug is likely to pose to the public.<ref>{{cite journal | vauthors = Qato DM, Alexander GC | title = Improving the Food and Drug Administration's mandate to ensure postmarketing drug safety | journal = JAMA | volume = 306 | issue = 14 | pages = 1595–1596 | date = October 2011 | pmid = 21990303 | doi = 10.1001/jama.2011.1457 }}</ref>