243475 Life saving diet products: A corporate smoke & mirrors job?

Monday, October 31, 2011: 11:30 AM

Kate Ryan, MPA , National Women's Health Network, Washington, DC
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.

Learning Areas:
Advocacy for health and health education
Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
1. Identify the impact of corporate influence on the demand for weight-loss products. 2. Evaluate the safety and effectiveness of marketed and proposed weight-loss products. 3. Assess the potential of the FDA user fee program to serve as a vehicle for strengthening FDA authority.

Keywords: Drug Safety, Obesity

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: I will be discussing some products that have been submitted to the FDA for approval. I will discuss infomation from public meetings on these products and data publicly available on the FDA's website.

Qualified on the content I am responsible for because: I develop and implement a program of legislative and regulatory advocacy that focuses on reducing women’s exposure to unnecessary drug and medical treatment risks.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.