I’m sorry are we bothering you with all this obesity stuff?
As you know the FDA was quite busy this last 12 months or so with reviews of Meridia, Qnexa, lorcaserin and Contrave. Meridia is off the market now while the other three are holding on for dear life. It came as no shock to those closely watching the meetings of the Endocrinologic and Metabolic Advisory Committee that the FDA really doesn’t much like dealing with obesity. Now, we know why. They are not curing hypertension or diabetes. That’s what the head of the FDA drug center, Janet Woodcock, right, wanted to see. And that’s what she told Reuters in this interview. FDA official sees drug approvals rising | Reuters
So, think about this for a moment, the top FDA drug official casually tosses off the FDA’s own guidances for developers of obesity drugs regarding efficacy and says, well, she wishes they were other drugs entirely. Imagine if she said, well, we have turned down this drug for breast cancer because it didn’t improve Alzheimer’s disease or cure multiple sclerosis. Or if she said of a drug rejected for HIV/AIDs, that she would like to have seen it cure Parkinson’s disease? Would she stay in office the rest of the day? Would it not be a huge embarrassment to the FDA, the HHS, the medical community, the Administration? Why is it ok for obesity? Is is any less intellectually vapid? Is that why one of people who works for her, running the Endocrinologic and Metabolic Advisory Committee process this year, apologized, APOLOGIZED! to the panel for “putting them through this unpleasantness.” The “unpleasantness” Dr. Coleman was referring to was the Committee’s job, namely, reviewing new drug applications for obesity. Dr. Coleman, went on to add, “I guess you should be thankful you don’t have to do this everyday for your living.” (See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf at page 304) Is this a cry for an intervention, a plea for a new job? Or a sign of an institution so biased against all this obesity that no obesity drug will ever be approved no way, no how? Can these people give obesity drugs a fair hearing? The FDA has rules on Conflicts of Interest. How about rules on Lack of Interest?
bill for the Department of Agriculture and Related Agencies, which includes the Food and Drug Administration. The Report includes the following language, “Obesity Therapeutics- The Committee is concerned with the absence of novel medicines to treat obesity, the second leading cause of preventable deaths in the United States and a disease linked to cancer, high blood pressure, heart disease, diabetes, and stroke. With only diet, exercise, and gastric surgery as options, the lack of obesity medications is a significant unmet medical need. The Committee directs FDA to report by March 30, 2012 on the steps it will take to support the development of new treatments for obesity, including the use of its Risk Evaluation and Mitigation Strategy and other post-marketing authorities, to mitigate risk and ensure rigorous post-market scrutiny while increasing access to novel medications. “ No doubt this will continue to put pressure to have FDA act more positively to find ways to find approvable drugs.
