At our Baltimore symposium, Dr. Ryan Irvine told us all about “follow-on biologics” or FOBs, potentially cheaper versions of the brand-name biologics we use today. At issue is pending legislation that could waive clinical trials and classify a follow-on biologic as interchangeable with its brand-name version—a move that affects your safety, how well your treatment works and whether you and your doctor have any say in what treatment you receive. You will read all about this in our October issue that you will receive very shortly.  The main areas of contention are:

1. Need for CLINICAL TRIALS.  Certain people in Congress want to bring FOBs (in our case, similar versions of Botox or Myobloc) to market without clinical trials.  We say that clinical trials are the only way to gather credible evidence so that physicians and patients can be assured the prescribed medicines are safe and effective
2. INTERCHANGEABILITY. Suppose you go in today for your Botox or Myobloc injections.  Do you want, all of a sudden, to be given something else because Medicare is dictating your choice without your doctor’s consent.  All because of the cost factor, not YOUR health factor. Is this good medicine?
3. IMMUNOGENECITY.  This refers to the degree to which a medicine can cause an immune response.  Your body may reject the medicine, attempt to destroy the medicine or shut down certain systems within the body as a way to defend itself.   Since FOB manufacturers are likely to use different production methods than brand-name manufacturers, the risk of immunogenecity with these follow-on biologics increases and, lastly.
4. MANY PEOPLE MAY THINK that because the above points refer only to Medicare they don’t have to worry as they have private insurance, but, when Medicare does anything all private insurance companies fall in line. Thus, we will all be affected.

If you feel that you want your congress person to vote against this, we recommend you read over the enclosed sample letter on the next page, type or write your own version and send it on.  We believe it best you do so on your stationery as it will have more impact.

Would you want to participate in a special National Dystonia Advocacy Day? It would be held sometime during the month of April and would require going to Washington, D.C. for the purpose of calling on key legislators and dealing with specific subjects. We expect to pay expenses for your trip. Please let us know if you would and also include the names of your Congress people. Approximately 10 people will be chosen. We’ll then be in touch. Thank you.