Patient safety is our highest priority and we are committed to disclosing the benefits and risks of our therapies to help healthcare professionals and patients make informed treatment choices.
Biogen has an ethical and regulatory responsibility to continually assess and communicate the benefit/risk profile of our products to patients, healthcare professionals and regulators.
On an ongoing basis we collect information regarding adverse events and other safety information from patients, caregivers and healthcare professionals, among others. Additionally, in some instances, we conduct post-marketing studies to evaluate therapies’ long-term effects.
Our safety and benefit risk management team reviews safety information received from all sources (foreign, domestic, clinical trials, published literature, post-marketing) for our products and determines what actions, if any, may need to be taken with reference to the evolving safety profile of our products.
When a potential safety issue is identified, we seek information to better understand the issue and we report our findings to applicable regulatory agencies. We also communicate newly identified product information to healthcare professionals and patients by updating the product labeling and providing other communications, as necessary.