FDA Review of New Drugs, June 2011

FDA Review of New Drugs, June 2011

On behalf of The Obesity Society (TOS), the leading scientific society dedicated to the study of obesity, we would like to express our deep concern over the Food and Drug Administration’s (FDA) approach to evaluating new and promising medications (Contrave, Locaserin and Qnexa) to help treat Americans affected by obesity.

Our nation is in the grip of a public health epidemic unlike any it’s seen before, with a widespread and devastating impact on health and life. More than two-thirds of U.S. adults are overweight or obese, and as a result are either present or potential victims of the damaging health consequences of obesity. One out of every eight deaths in America is caused by an illness directly related to obesity. Research has clearly documented the harmful health effects of excess body weight, which increases risk for conditions such as diabetes, hypertension, sleep apnea, hip and knee arthritis, low back pain and depression.

Since 1982, The Obesity Society has been committed to encouraging research on the causes and treatment of obesity, and to keeping the medical community and public informed of new advances. Over the last twelve months, the FDA has made critical decisions regarding three new drug applications for the treatment of the disease of obesity. Unfortunately, in each case, the FDA chose to either reject its own draft guidance or establish unreasonable pre-market approval trials, before the agency would allow these new drugs to enter the market – even under strict indications and dosing requirements for those seeking access to these promising new drugs.

Surprisingly, given the terrible toll obesity takes on our country’s public health, we currently have very few clinical options available to treat this condition and reduce its damage. There is currently only one approved obesity medication on the market and few new options on the horizon -- perhaps due in part to what are perceived by many obesity researchers as daunting regulatory hurdles unlike those that face new medications for any other disease. In the absence of approved medical treatments, given the physical and emotional costs of obesity, millions of individuals affected by obesity turn to fad diets and untested dietary supplements which may further damage their health.

On March 22, TOS joined with the Obesity Action Coalition, the American Dietetic Association, and the American Society for Metabolic and Bariatric Surgery in meeting with key FDA staff to reinforce our collective message that new evidence-based treatment approaches for the disease of obesity must be subject to, and judged by, the same approval criteria as new treatments for other major diseases. And while we were pleased that this meeting was the beginning of a productive ongoing dialogue with the agency, we retain the concern we expressed to the agency that they are not utilizing all of the tools (especially those afforded it by Congress) to allow these drugs to reach even a targeted population under a robust risk mitigation strategy. If this outcome is allowed to stand, it will leave even fewer treatment options for those who struggle with obesity and will likely further discourage any research and development in the area of obesity ever again.