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The Senate Committee on Health, Education, Labor, and
Pensions (HELP) has released draft legislation that would give the FDA broad
authority to remove compounded medications from the market in one of two ways: either
by putting bulk ingredients on a list of “banned” compounded drugs, or by redefining
compounded variations of approved drugs as illegal “copies.”
The way the bill is written, a compounded medication—like the
low-cost pregnancy medicine 17P (a version of KV Pharmaceutical’s hugely
expensive drug Makena), or a compounded version of Genentech’s cancer treatment
drug Avastin, or bioidentical estriol that can be used instead of Pfizer’s
dangerous Prempro—would likely be banned. The bill could also ban time-release
versions of some medications, as well as some veterinary drugs.
Ask the committee members to strike the extreme language in
this bill that has nothing whatsoever to do with safety.
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]