While ASBP understands and appreciates the cautious manner in which certain anti-obesity drugs are viewed, the FDA seems to lose sight of the many health risks associated with obesity. Obesity-related health risks include diabetes, heart disease, stroke, osteoarthritis, and several types of cancer, to name just a few. There is ample evidence that obesity is a metabolic abnormality and that pharmacologic interventions can help with weight loss and maintenance, reversing or delaying the development of obesity-related health problems.
Furthermore, the ASBP finds it contradictory that the FDA advisory panel recently recommended lowering the BMI requirement for lap-band surgery without asking for further long-term outcome studies. Meanwhile, the FDA rejected Contrave and requested the company conduct a study of sufficient size and duration to address the risk of heart attack and stroke. Unfortunately, such studies will likely be costly and require several years to complete, which means that significant time will pass before this drug comes up for approval again.
The ASBP expects the FDA to consider the demonstrated effectiveness and benefits of weight-loss drugs even if those drugs may carry increased hypothetical risk, because a reduction in obesity leads to a multitude of beneficial effects, which far outweigh minor risks.
SOURCE ASBP