Prescription Obesity Drugs Essay -- Pharmaceuticals

1.Has FDA supportd 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 pen guidance that clearly defines their expectations to judge forcefulness (weight reduction and maintenance of weight loss after 1 years treatment). It similarly indicates an effective harvesting should provide improvements in blood pressure, lipids, and glycaemia so 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 show to result from a loss of system fat verified through advance screening tools. From a rubber eraser perspective, the FDA states the drug should not adversely uphold cardiovascular function partic ularly spotlight cardiac valvulopathy. 2.Has FDAs grounds for rejecting the NDAs of prescription diet pills in the last 10 years been based on safety/efficacy concerns? In 2010 alone, deuce-ace 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 want of diversity in the phase 3 trial population might result in efficacy of the drug being overstated while potentiality 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/committeesmeeting materials/drugs/endocrinlogicalandmetabolicdrugsadvisorycommittee/ucm225631.pdfFDA. (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 -- Pharmaceuticals1.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 registr ation 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 years 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 FDAs 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 appro val. 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.pdfFDA. (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 C onsortium (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