Prescription Obesity Drugs Essay -- Pharmaceuticals

1. Has FDA provided ‘sufficient guidance’ to guide development and registration of prescription diet medications? If you agree, provide examples of what you consider ‘sufficient advice’ (including date of publication). I believe the FDA does provide sufficient guidance on the development and registration of prescription diet medications. In 2007, FDA issued draft guidance that clearly defines their expectations to judge effectiveness (weight reduction and maintenance of weight loss after 1 year’s treatment). It also indicates an effective product should provide improvements in blood pressure, lipids, and glycaemia therefore changes in common weight-related comorbidities need factored into clinical trial to assess efficacy. FDA also states it expects to see drug-mediated weight reduction demonstrated to result from a loss of body fat verified through advance screening tools. From a safety perspective, the FDA states the drug should not adversely affect cardiovascular function particularly highlighting cardiac valvulopathy. 2. Has FDA’s grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on safety/efficacy concerns? In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi... ... FDA. (2010). FDA Briefing Document: NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg. Sponsor: Arena Pharmaceuticals Advisory Committee. Retrieved from http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdf FDA. (2007). Guidance for Industry. Developing Products for Weight Management. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf FDA. (2011).Predictive Safety Testing Consortium (PSTC). Retrieved from http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.html McCallister, E. (2011). BioCentury, Obesity Reset. Retrieved from http://www.biocentury.com/promotions/obesity/next-generation-of-obesity-drugs-unlikely-to-reach-regulators-before-2014.html Prescription Obesity Drugs Essay -- Pharmaceuticals 1. Has FDA provided ‘sufficient guidance’ to guide development and registration of prescription diet medications? If you agree, provide examples of what you consider ‘sufficient advice’ (including date of publication). I believe the FDA does provide sufficient guidance on the development and registration of prescription diet medications. In 2007, FDA issued draft guidance that clearly defines their expectations to judge effectiveness (weight reduction and maintenance of weight loss after 1 year’s treatment). It also indicates an effective product should provide improvements in blood pressure, lipids, and glycaemia therefore changes in common weight-related comorbidities need factored into clinical trial to assess efficacy. FDA also states it expects to see drug-mediated weight reduction demonstrated to result from a loss of body fat verified through advance screening tools. From a safety perspective, the FDA states the drug should not adversely affect cardiovascular function particularly highlighting cardiac valvulopathy. 2. Has FDA’s grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on safety/efficacy concerns? In 2010 alone, three drugs reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) have failed to gain approval. EMDAC felt each drug (naltrexone/bupriopion, lorcaserin and phentermine/topiratate) had unacceptable safety issues (particularly cardiovascular risk profiles). The committee also concluded that lorcaserin did not provide enough convincing evidence of efficacy and safety to gain approval. EMDAC cite lack of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potential safety risks understated. Whi... ... FDA. (2010). FDA Briefing Document: NDA 22529 Lorqess (lorcaserin hydrochloride) Tablets, 10 mg. Sponsor: Arena Pharmaceuticals Advisory Committee. Retrieved from http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdf FDA. (2007). Guidance for Industry. Developing Products for Weight Management. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf FDA. (2011).Predictive Safety Testing Consortium (PSTC). Retrieved from http://www.fda.gov/AboutFDA/PartnershipsCollaborations/PublicPrivatePartnershipProgram/ucm231132.html McCallister, E. (2011). BioCentury, Obesity Reset. Retrieved from http://www.biocentury.com/promotions/obesity/next-generation-of-obesity-drugs-unlikely-to-reach-regulators-before-2014.html