In the interest of disclosure, I work for a pharmaceutical company. However, this post is purely my opinion and not that of my company.
I heard about this bill and I was intrigued.
View the bill here.
I am all for bringing medicines to market as quickly as possible, especially lifesaving drugs. However, this bill is dangerous. In one section, it states that rather than having to prove equivalence through clinical trials, medicines can be considered equivalent and marketable if
Two protein biological products with differences in structure between them solely due to post-translational events, infidelity of translation or transcription, or minor differences in amino acid sequence.
The part that worries me is “minor differences in amino acid sequence.” What is “minor?” Just a few changes is the difference between insulins for different species, or in the bioavailability of the insulin in the body. What makes this even more complicated is that just a different ethnicity can affect the uptake of insulin by the body.
The difference of even one amino acid can be the difference between a lifesaving insulin and a degradant that must be limited. Using language as generic as “minor difference” could lead to a product being marketed as “equivalent” with little or no safety testing. My test for what is right is: would I give this medicine to my mother or another loved one? In this case, I would not feel like there was enough clinical data and I would not give it to someone I loved.
Surely there is a better way to bring medicines to the market quickly.