FDA Regulations

FDA REGULATIONS WE MUST FOLLOW

Learn about the FDA regulations that Biogen must follow

My name is Tammy, and I am Vice President of Regulatory Affairs at Biogen. I head the Advertising, Promotion & Labeling group, and I have worked at Biogen for more than 24 years.

Pharmaceutical companies operate under many Food and Drug Administration (FDA) regulations to ensure quality and compliance. It is my group’s responsibility to ensure Biogen complies with the FDA’s advertising and promotion regulations. These regulations provide the guidelines for what we can and cannot say about our treatments. This article is intended to share with you some insight on the regulations we must follow. I hope you find this information interesting and that it answers some questions you may have about what information Biogen shares or does not share about its relapsing multiple sclerosis (MS) treatments.

Can we say anything we want about our treatments? 

No! If it was only that easy. All pharmaceutical companies must comply with the FDA’s rules about advertising and promotion of prescription drugs. There are specific regulations that we must follow when we talk about our treatments. Some examples include:

  • We can only share information that is contained in the drug’s label. This is data that FDA has specifically reviewed and found to be clinically correct. The drug’s label comes with your treatment and provides safety information about the medicine
  • We cannot compare our treatments with other treatments unless there has been a clinical study that directly compared the 2 treatments. You may have heard this referred to as a “head-to-head” study. This is why we cannot talk about how our treatments may work compared with another company’s treatment. It is simply not permitted
  • We have to be truthful and not misleading. We cannot present our data in a way that makes it look more effective than it really is. For instance, we cannot imply that less frequent injections make the drug work better if that isn’t actually clinically proven to do so
  • Why do we put so much safety information into our materials? I know that trying to understand how our treatment might help your relapsing MS is confusing and maybe even frustrating when you also have to read about all the “bad” stuff. We call those adverse events. We are required to disclose all of the adverse events when we have information on how our treatments might help you or impact your disease. We try to make this information as understandable as possible while also complying with the FDA regulations. Please know that we are always looking for ways to improve how we share this type of information
  • There are rules on how we talk about MS if we also talk about our treatments. This website is devoted to sharing general health information with people living with MS. For example, there is content about nutrition and exercise, and tips to help you get through the day. This content isn’t part of the label or safety information that comes with our relapsing MS treatments, so we can’t talk about those treatments on the same site

What does all that mean to you? It means that Biogen thoughtfully, carefully, and with great care developed Above MS to give you general information about MS—symptoms, things to be aware of and discuss with your doctor, exercise tips, and nutrition tips. Biogen recognizes the importance of providing this information to help facilitate discussions with your doctor. But the one thing you won’t find specifically on the website is information about our treatments. Not because Biogen does not want to share that information with you, but because we chose to develop a website where we could share all types of information.