Action Alert! If you are a resident of
Alaska, Connecticut, Colorado, Georgia,
Illinois, Iowa, Kansas, Kentucky, Maryland,
Massachusetts, Minnesota, North Carolina,
Pennsylvania, Rhode Island, South Carolina,
Tennessee, Utah, Vermont, Washington,
Wisconsin, or Wyoming,
please contact your member of the Senate HELP Committee
and ask him or her to strike the extreme language in this bill
that has nothing whatsoever to do with safety.
Please take action immediately!
reply-to: Alliance for Natural Health USA office anh-usa.org
date: Tue, May 7, 2013 at 4:29 PM
Don't Let the FDA Take Away Your
Access to Compounded Medications
On April 26, the Senate Committee on
Health, Education, Labor, and Pensions (HELP)
released draft legislation that would “clarify”
the FDA’s ability to regulate
both compounding pharmacies
and the compounded medications themselves.
It’s our understanding that the draft bill
was written with the specific intent of
giving 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 could be banned
—like the low-cost pregnancy medicine 17P
(similar to KV Pharmaceutical’s
hugely expensive drug Makena),
or a bioidentical estriol that can be used instead of
Pfizer’s dangerous (and not bioidentical) Prempro.
There’s a silver lining, however:
the bill will cost Medicare and Medicaid billions of dollars,
because these programs rely on the more
cost-effective compounded versions of these drugs,
so there may be some serious push-back on it.
It’s possible that this bill would not only
federalize compounded medications
dispensed by prescription,
but give the FDA authority over the
state regulation of the practice of medicine!
It would require that a practitioner certify on the prescription
that the compounded variation produces
“a significant difference from
the marketed drug version.”
Of course, the mere fact that the doctor is
prescribing the medicine in the first place
should be justification enough
—the federal government should not interfere
with the practice and prescription of medicine.
The bill bans compounded drugs that are
a “copy of a marketed drug,”
but defines it so broadly that most compounded drugs
could be removed from the market,
thereby increasing healthcare costs
and limiting patient access to important medications.
Millions of women depend on access to
Critical (complete) thyroid medications
would also be at risk.
The bill would also ban certain veterinary medicines.
Compounding pharmacies sometimes create a convenient,
topical version of a marketed drug
that is only available in oral form,
for use on the many pets who don’t like taking pills.
Even worse, the bill would give FDA the power to
disallow entire categories of drugs
that could be compounded,
such as “extended release products.”
Compounding pharmacies currently offer
time-release, complete, desiccated thyroid compounds,
which can be difficult to find elsewhere.
Most thyroid medications made by drug companies
are not complete,
and some of these important thyroid medications
are never available in time-release versions.
The FDA has in the past attempted (unsuccessfully)
to ban bulk bioidentical estriol
at the request of a pharmaceutical company.
With this bill, the ban would be much more likely.
If the pharmaceutical industry were to
come up with a wish list,
we’d imagine banning compounded medicines
would be at the very top.
It seems clear that this legislation will be
presented as a response to the problems at
the New England Compounding Center .
Poor quality controls at the facility led to some
steroid injections becoming tainted with a fungus
—an outbreak which FDA Commissioner
Margaret Hamburg conceded last month
was due to lack of FDA action
despite many complaints they had received
about the facility coupled with
“a confusing legal landscape.”
Hamburg asked for a consistent set of safety regulations
that would require compounding pharmacies
to report any problems associated with their drugs.
Instead, it seems the bill does little to
increase the safety of compounded medicines
or improve facility inspections,
but rather makes it easier for FDA to
ban many compounded drugs altogether.