WASHINGTON, D.C. (September 12, 2017) – Pharmaceutical Research and Manufacturers of America (PhRMA) director, Public Affairs, Andrew Powaleny issued the following statement following U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb’s address to the Regulatory Affairs Professionals Society 2017 Regulatory Conference:
“While the pace of science has evolved considerably, the simple fact is from drug discovery through U.S. Food and Drug Administration (FDA) approval, developing a new medicine takes 10-15 years and costs an average of $2.6 billion. America’s biopharmaceutical research companies are committed to working with the FDA to explore innovative approaches to drug development and clinical trials aimed at enhancing the efficiency of the development and review processes and accelerating patient access to safe and effective medicines. The recently enacted legislation, 21st Century Cures Act and the FDA Reauthorization Act provide the Agency with the ability to explore new novel approaches for studying the clinical safety and efficacy of new medicines. These modern approaches to clinical trials should embrace appropriate methodologies that reflect the current state of science, including adaptive study designs, model-informed drug development as well as the use of real-world evidence for regulatory decision-making.”
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $58.8 billion in 2015 alone.