WASHINGTON, D.C. (July 12, 2018) – Pharmaceutical Research and Manufacturers of America (PhRMA) spokesperson Andrew Powaleny issued the following statement on comments made by U.S. Food and Drug Administration Commissioner Scott Gottlieb:
“We agree with Commissioner Gottlieb that the use of real-world evidence and innovative clinical trial designs hold great promise for enhancing the drug development process. When leveraged with the latest science and methodologies, these approaches can lead to more efficient drug development programs, provide more robust information about the benefits and risks of new medicines and can ultimately lead to more timely access to innovative, safe and effective medicines for patients.
“PhRMA stands ready to work with the U.S. Food and Drug Administration (FDA) to advance regulatory acceptance of real-world evidence as part of the dedicated initiatives included in the Prescription Drug User Fee Act VI and the 21st Century Cures Act. Through these collaborative efforts, we anticipate the outcomes of the FDA pilot programs and issuance of Agency guidance documents will provide greater certainty and predictability in drug development and regulatory review to help our companies design trials which better meet patients' needs and keep pace with scientific advances.”
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 $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.