[DATE]

Dear [NAME OF CONGRESSIONAL MEMBER],

My name is [YOUR NAME] and I live with a severe neurological movement disorder called spasmodic torticollis (ST). ST is caused by an increase of neurotransmitters being released in the brain. These increased nerve signals travel through muscles in the neck causing spasms and pulling and resulting in excruciating pain and debilitation. More than one million people in the U.S. have ST.

The most common form of treatment for ST is to get injections of botulinum toxin into the affected neck muscles, which basically deadens the nerves in the area that is experiencing spasms. Two brands of botulinum toxin are currently available: Botox® (strain A of botulinum toxin) and Myobloc™ (strain B of botulinum toxin). Botox and Myobloc are biotechnology medicines or “biologics” that are made from living cells and developed through a highly complex and expensive process.

Congress is now debating legislation that would define an abbreviated regulatory pathway for “follow-on biologics,” which are similar versions of the brand-name biologics that are currently on the market.

I believe a legal pathway to approve follow-on biologics is needed, but must include rigorous scientific standards and requirements for clinical trial evaluations. Unlike traditional chemical drugs, biologics are made of living organisms and have a complex structure. While follow-on biologics may be similar, they can never be exact copies. Even small differences between a follow-on biologic and a brand name biologic can cause differences in effectiveness and possibly serious side effects.

Moreover, I believe a follow-on biologic should not be considered “interchangeable” with its reference product without a doctors’ approval. Some members of Congress would like to permit interchangeability, which would allow my health insurance carrier to refuse payment for a brand-name biologic if a follow-on version exists. Interchangeability is a common practice for generic chemical drugs, where the brand-name and generic version must have identical active ingredients.   In sharp contrast, the draft legislation would permit substitution of a brand-name biologic with a follow-on biologic, despite it having a different active ingredient. 
 
Please protect my right to safe and effective treatment by supporting follow-on biologics legislation that requires manufacturers to conduct clinical trials and does not allow interchangeability. Only my physician should be able to prescribe a biologic, whether follow-on or brand-name, based on his own review of the data and his own clinical judgment of what’s best for me.

If you would like additional background on this issue, please contact me at [YOUR PHONE AND EMAIL].

Thank you for your consideration.

Sincerely.

[YOUR NAME]