Policy Debate: The US food and drug administration and new drug approvals: A safety vs. innovation paradox?

The US Food and Drug Administration (FDA), founded in 1906, is an agency of the US Department of Health and Human Services, an executive department of the United States Government. The FDA is legislatively responsible for regulating and supervising food safety, tobacco products, dietary supplements, prescription and over-thecounter drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products, and cosmetics. The FDA's Center for Drug Evaluation and Research is responsible for approving three types of ethical drugs: new drugs ('new drug applications, NDAs' or 'biologics licensing applications, BLAs'), generic drugs and over-the-counter drugs. A drug that is approved by the FDA is deemed 'safe and effective when used as directed'.Based on unofficial data compiled from the FDA, 21 new molecular entities and novel biologics (hereafter NDAs and BLAs) were approved by the agency in 2010 - the lowest number of NDAs/BLAs since 2007 when 18 were approved (Larkin, 2010). Some analysts have conjectured that the FDA is being overly cautious in approving NDAs/BLAs due to a tougher safety approach, including those treating obesity, such as GlaxoSmithKline's Avandia, which was sharply curtailed, and diabetes, including Abbott Park's Meridia, which was removed from the marketplace (Dooren, 2010). Earlier, in 2004 and 2005, two high profile arthritis drugs, Merck's Vioxx and Pfizer's Bextra respectively, were removed from the marketplace amid allegations of an inadequate FDA drug safety approval review process.Recently, FDA Commissioner Margaret Hamburg acknowledged that 'we can do a better job of assessing safety and, partly we need to do a better job because science is evolving' - although, she does not want to stand in the way of the practice of medicine or improving health (Silverman, 2010). 'If the rules get too onerous, it could potentially keep innovative drugs out of US hands', says Les Funtleyder, a fund manager at Miller Taback & Co. in New York City (Larkin, 2010). Yet, according to FDA spokeswoman Sandy Walsh, the agency has initiated 'no systematic change in how the FDA is approaching drug approvals (Dooren, 2010)'. Given these contrasting opinions on the impact of new agency safety initiatives, what is the recent record of the FDA on new drug approvals?FDA APPROVALS AND NEW DRUG SAFETY INITIATIVESUnlike the 'standard' review process followed by the FDA, i.e., applied to drugs that offer only minor improvement over existing commercialized drugs, the FDA's 'priority' review process focuses on drug products that treat serious diseases and drugs for less serious illnesses, and its' goal is to shorten the time it takes from completed application until an approval decision from 10 months ('standard') to 6 months ('priority') (U.S. Food and Drug Administration, 2011). An analysis by Business Insights (Sahoo, 2008), covering the period from 1995-2007, concluded that both 'standard' and 'priority' approvals have fluctuated, with no overarching trend from year-to-year. However, when Business Insights (Sahoo, 2008) examined new NDA/BLA approval trends, i.e., 'standard' and 'priority', in 6-year increments, the period from 1996-2001 had significantly more FDA NDA/BLA approvals than the 2002-2007 period. With just 450 FDA NDA/BLA approvals from 2002-2007 compared with 523 in 1996-2001, the volume of NDA/BLA drug approvals declined by 13.9% in the latter period (Sahoo, 2008). First-cycle reviews for priority NDAs were 47% in fiscal year 2003 and increased to 70% in fiscal year 2007, but slipped to 53% in fiscal year 2009 (Silverman, 2010).In 2007, the US Congress passed the FDA Amendments Act, authorizing the FDA with new drug safety responsibilities and mandated that the agency establish novel programs to prevent and detect adverse drug reactions, especially when multiple prescription drugs are being used simultaneously by patients on a chronic basis (Hamburg, 2009). …