Life saving diet products: A corporate smoke & mirrors job?

With the rising rates of obesity and its associated health conditions, there is a call from doctors and patients for treatments – and pharmaceutical companies and medical device manufacturers are rushing to meet that need. In the past year alone, the Food and Drug Administration (FDA) has evaluated three new weight-loss drugs and considered expanding the use of a device used in weight-loss surgery. However, in each of these cases the industry has presented bad science while trying to convince the FDA that a dangerous product is safe or that an ineffective product works. Consumer advocacy organizations have challenged corporate claims that unanswered safety questions or low effectiveness are acceptable given the unmet need for FDA-approved weight-loss products. The author will review the evidence for the safety and effectiveness of these products, share examples of over-blown marketing claims, and identify avenues for consumer and professional advocacy to strengthen regulatory requirements. Through reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), consumer health advocates can work to ensure that the FDA has the statutory authority it needs to rein in corporate influence – whether that is requiring post-market studies, regulating direct to consumer advertising, or mandating a recall.