id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-18832	Bard, Jennifer S.	Putting Patients First: How the FDA Could Use Its Existing Powers to Reduce Post-Market Adverse Events	2012	66	.pdf	application/pdf	22899	917	46	The FDA faces a difficult challenge in balancing the interest of the sponsors to recoup their investment by getting new products on the market quickly and that of the public which deserves a better understanding of the limits to which the FDA, the Sponsor or even the prescribing physician know of the risks when the product gets used in real life.9 5 PREVENTING ADVERSE DRUG EVENTS To DECREASE HOSPITAL COSTS (2001), available at http://www.ahrq.gov/qual/aderia/aderia.htm (last visited April 30, 2013) (Adverse drug events (ADEs) result in more than 770,000 injuries and deaths each year and cost up to $5.6 million per hospital, depending on size. See Ananya Mandal, Older Drugs May be Better Than Newly Approved Ones, NEWS MEDICAL (Sept. 13, 2011) (quoting Dr. Michael Carome, deputy director of Public Citizen's Health Research Group), http://www. news-medical.net/news/20110913/Older-drugs-may-be-better-than-newly- approved-ones.aspx. 7 21 U.S.C. § 355(o)(3)(B). 8 For an overview of FDA drug regulation see Susan Thaul, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, Congressional Research Service (2012) http://www.fas.org/sgp/ crs/misc/R41983.pdf; see 21 U.S.C. §355(b)(6)	cache/ihlr-18832.pdf	txt/ihlr-18832.txt