PhRMA Statement on FDA Guidance on Remote Interactive Evaluations for Oversight of Drug Manufacturing Facilities During COVID-19
WASHINGTON, D.C. (April 15, 2021) – Pharmaceutical Research and Manufacturers of America Executive Vice President of Science and Regulatory Advocacy and Chief Medical Officer Dr. Richard Moscicki made the following statement:
“The U.S. Food and Drug Administration (FDA) guidance on remote interactive evaluations is an important step from the Agency in describing actions it may take to evaluate and oversee manufacturing facilities and enable timely regulatory decision-making. The biopharmaceutical industry recognizes that the COVID-19 pandemic has presented novel challenges to FDA in its regulatory oversight of manufacturing facilities. We applaud the FDA for adapting to these unique challenges and taking steps to describe the ‘remote interactive evaluations’ the Agency may conduct to facilitate regulatory decision-making and ensure timely access to new, innovative treatments for patients.
“This guidance and associated FDA actions are consistent with the Agency’s mission of protecting and promoting public health. Yesterday’s announcement provides important considerations including:
- Explicit recognition that the use of remote interactive evaluations will generally enable FDA to meet its user fee goal dates.
- Embrace of virtual technologies to facilitate FDA’s oversight of manufacturing facilities and regulatory decision-making.
- Recognition that discussion with manufacturing facilities on logistics, responsibilities and expectations is critical to enabling remote interactive evaluations.
- Clear guidance on actions FDA will take to conclude a remote interactive evaluation and how the Agency may use information obtained during such an evaluation.
“We look forward to working with the FDA and continuing our ongoing dialogue with the Agency as both the Agency and industry gain experience with remote interactive evaluations.”
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 nearly $1 trillion in the search for new treatments and cures, including an estimated $83 billion in 2019 alone