Here was my quick, imperfect comment on the FDA site. It would be good if others could share theirs here too so people can have material to work with:
I've been using b-HCG for the past 18 months to maintain my fertility. My b-HCG comes from a 503B compounding pharmacy (Empower Pharmacy). Without access to my compounded b-HCG, I would be forced to pay 2-5 times as much for b-HCG. The compounded product is also much more readily available and does not face the shortages of the local pharmacy products, which often go short or spike radically in price. I have heard of people having to pay $500 for a single bottle, whereas my compounded product is around $30.
With access to my compounded b-HCG, I can have a chance to start a family. Without it, I would be forced to start paying so, so much more for b-HCG, or risk my fertility being shut down.
Additionally, products such as FSH are available via Empower Pharmacy, which I'm interested in using in the future. The compounded FSH is affordable, whereas the non-compounded product could cost me around $15,000 for a cycle needed for conception. This is outrageous.
The intend of the BPCI Act was to lower prices for consumers like me. The enforcement here will do anything but that. I ask that the FDA allow compounders to continue producing some of these biologic products such as HCG and FSH, which were long, long ago approved by the FDA and are identical in formulation to known products. Otherwise only the extremely wealthy will be able to afford their fertility with these products like HCG and FSH.
