In a surprise vote, the FDA Advisory Committee voted to approve Orexigen Therapeutics obesity drug, Contrave. The vote was 13 to 7. This is the first obesity drug to win approval since 1999. The FDA will make the final decision but they usually follow the recommendations of their advisory committees. This opens the door for Vivus to obtain approval since their drug, Qnexa, had a superior efficacy finding. It probably also helps Arena’s lorcaserin to obtain a more favorable decision by the FDA. See F.D.A. Panel Backs New Diet Pill – NYTimes.com
This is my oral statement to the Advisory Committee:
Good Afternoon. Thank you for this opportunity to testify on this important issue.
Obesity is a fatal, chronic, relapsing disease affecting both genders, all races, ethnicities and ages. It is the most prevalent chronic disease of the 21st Century.
Obesity is recognized as a major cause of mortality, disability, morbidity, health care utilization and health care costs.
Increases in lifespan due to advances in the treatment of cardiovascular disease are being offset by increases in deaths due to obesity and diabetes.
No other disease combines obesity’s prevalence and prejudice, sickness and stigma, death and discrimination.
The question before the FDA is whether or not pharmacology will be part of the solution to the obesity epidemic.
The lack of FDA approval of an obesity drug since 1999 has resulted in both large and small pharmaceutical and biotech companies pulling out of research and development of drugs to treat obesity.
Consumers are left with few choices.
Physicians have little to offer patients.
By its actions, the FDA is making it clear that this disease will not be treated by drugs. This is a staggering reversal of the FDA’s duty to protect the public health and an abandonment of millions of Americans trying to avoid the numerous adverse consequences of excess body weight.
I urge you to approve this medication.