Former FDA Medical Officer and FDA’s Subject Matter Expert
FDA Medical Officers serve on a federal level in several governmental agencies, including the FDA. Medical Officers as the FDA’s front-line individuals who directly communicate with drug companies applying for new-drug approvals, labeling supplements, et cetera. Medical officers are responsible for all major FDA decisions and are the official voice of the FDA. Full drug reviews are conducted my a multidisciplinary team of pharmacologists, chemists, quality control engineers, toxicologists, and statisticians, but the final review and the ultimate approval or rejection of a drug is issued in the form of a report from the FDA medical officer. Although other consulting groups may rather misleadingly state “we have worked with the FDA” or state “we have FDA experience” it is important that experts have actually worked internally at the FDA in order to fully understand the review and approval process in order to accurately label themselves as an “FDA expert.”
To speak with an experienced former FDA medical officer, please contact us by telephone or email FormerFDA.com
The Merck SEARCH Trial: (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) compared the simvastatin side effects of simvastatin 80mg and simvastatin 20mg. As part of its safety arm, The Merck’s SEARCH trial evaluated the muscle safety/ rhabdomyolysis and efficacy signals between both dosing groups.
The results of this trial were critical since simvastatin 80mg is a commonly prescribed high-dose statin medication, and rhabdomyolysis is a statin side effect that occurs with all seven of the currently available statins approved by the FDA.
Compared to all other statins, simvastatin 80 is the least expensive statin relative to its potency and, therefore, has the most statin side effects because of the relative abundance of postmarketing FDA safety/rhabdomyolysis and efficacy data, since its FDA approval in 1992.
The Merck SEARCH trial completed approximately 12,000 patients over a 6.7 year period. An FDA expert and pharmacology expert/ drug expert are given charge of writing the FDA safety review of the Merck SEARCH trial and presenting the simvastatin side effects, including the muscle safety/ rhabdomyolysis postmarketing and efficacy data findings.