Doctors and Compounders Are Being Punished for the FDA’s Ineptitude- Alliance for Natural Health USA
Tuesday, June 10, 2014
Rewarding Bad Behavior:
and Compounders Are Being Punished for the FDA’s Ineptitude
Executive and Legal Director
Alliance for Natural Health USA
“I certify that this compounded
variation produces ‘a significant difference from the marketed drug version.’ ”
If Congress’s initial,
knee-jerk reaction to the 2012 New England Compounding Center
(NECC) meningitis tragedy had
become law, you would have had to add this federally mandated disclaimer to every
prescription you wrote for a compounded drug. It seems Congress, influenced by
pharmaceutical industry lobbying dollars, wanted to reward the FDA’s failure to
shut down grossly negligent compounding manufacturers—but did so by granting the
agency vast new powers.
Confused by this logic? Welcome
to Washington, DC.
My organization, the Alliance
for Natural Health USA (ANH-USA), and our allies eventually defeated the practitioner
certification provision. However, it was just another twist in the long, sordid
tale of the 2013 Drug Quality and Security
that will forever change consumer and practitioner access to compounded
Act I: Documented FDA Inaction Leads to Fifty-three Deaths
In 2002, the FDA began investigating Massachusetts’ NECC after
receiving reports that five patients had become ill after receiving its drugs.
However, the agency simply gave up its investigation after the
NECC’s owner refused to cooperate. Just a few months later, two patients
exhibited symptoms of bacterial meningitis after receiving NECC injections.
In 2003, FDA officials suggested the NECC be “prohibited from manufacturing”
until it improved its quality and safety controls, as there was very real “potential for serious public
However, the FDA deferred any real action to the state of Massachusetts.
The FDA inspected the NECC in
2004. Two years later, it issued a warning letter based on violations it found
during its inspection. In 2008, FDA received a complaint from its Los Angeles District
Office about problems with NECC products. Separately, a New England-based FDA
official recommended that the FDA inspect NECC. FDA declined, and instead sent
another warning letter.
In the fall of 2012, fourteen thousand patients received NECC spinal
injections that were contaminated with fungal meningitis.Over 700 people were sickened; fifty-three die.
Act II: Big Pharma Lobbyists Exploit the NECC Tragedy
ANH-USA’s experience on Capitol
Hill has taught us that for special interests, “tragedy” is just another word
In the wake of the meningitis
outbreak, Big Pharma lobbyists focused the legislative conversation on
“problems” with compounding pharmacies and medications. Unfortunately, they
found a willing audience: on April 26, 2013, the Senate Committee on Health,
Education, Labor, and Pensions (HELP) released compounding
rewarded the FDA’s ineptitude and inaction with expanded powers. The bill:
Granted the FDA the power to
remove most compounded medications from the market—summarily eliminating drugs
like bioidentical hormones (estriol) and clearing the way for more expensive
that doctors add a disclaimer to prescriptions for compounding drugs, which would have placed prescriptions
directly under federal scrutiny; and
a standard for compounded drug safety and efficacy that would have required
double-blind, random-controlled trials (RCTs)—a standard typically reserved for mass-produced prescription drugs!
Interestingly, that same month,
the House Energy and Commerce
that the FDA was at fault for the NECC tragedy: “After reviewing more than 27,000
documents, we found a dramatically different picture than the one painted by
the FDA…We found that FDA focused on perfecting their legal reasons for
inaction instead of protecting families.”
How can one reconcile the stark
difference between the conclusion of the Senate investigation (that the FDA had
ample power and choose not to act) and the April 2013 legislation (that the FDA
needs more powers in order to act)?
Three simple words: Follow.
gave campaign contributions to
eight out of the twenty-two members of the HELP Committee.
May 2013, the Working Group on Pharmaceutical
Safety went public,
revealing one of the most influential behind-the-scenes forces behind the HELP
committee’s legislation. WGPS is headed Tommy
G. Thompson, former US Secretary of Health and Human Services (HHS)
and current chairman of TherapeuticsMD, a founding member of WGPS.
July 2013, ANH-USA obtained a document in which TherapeuticsMD,
pitching itself to potential investors, named compounding pharmacies as
competitors in the coveted bioidentical hormone market.
Act III: The Integrative Health Community Strikes Back
Alarmed by how this legislation
would affect integrative patients and practitioners, my organization immediately
launched a multifaceted grassroots, lobbying, and publicity campaign to amend
the most dangerous aspects of the April 2013 compounding bill.
The fruits of our efforts were
clearly reflected in the final bill, which was passed in November
2013. The troubling elements of the original legislation that we were able to
Protecting compounded drugs
that have USP monographs for traditional pharmacies. This makes it much more likely
that medications like estriol will remain available for in-state patients.
Ensuring that compounding
pharmacies could continue to make non-standardized dosages of drugs, thus maintaining consumer
access to individualized dosages.
Removing specific language that
targeted extended-release products.
While the final language still permits the FDA to disallow entire categories of
drugs, the specific reference to time-released compounds has been removed.
Removing a “safety and
efficacy” requirement that could have forced compounders to perform RCTs. RCTs are not only inappropriate
for individualized medicine, but are prohibitively expensive (a single RCT
comes with a price tag of millions of dollars). This provision was simply a
backdoor approach to banning compounded medications.
Removing language that would
have mandated physician reporting within a few days. This gives doctors more time
and flexibility to treat patients as they see fit.
However, many concerns
remained. For example, the alarming distinction between traditional compounding pharmacies and outsourcing facilities: traditional
pharmacies will only be able to compound drugs that have a USP monograph, are
part of an FDA-approved drug, or are on a “pre-approved” FDA list, and will
only be able to send 5% of their total prescriptions out of state.
By comparison, outsourcing
facilities will be permitted to distribute out of state without restrictions
and won’t require individualized prescriptions. However, they will only be able
to produce drugs that are on a FDA-approved list (it’s likely this list will be
The full impact of the final
bill will not be known or felt until the FDA completes its rulemaking process.
However, after carefully analyzing the legislation and speaking with
compounders and doctors, we project a number of ramifications:
compounded drugs may be available. Drugs like bioidentical estriol, compounded
IV nutrients, desiccated (complete) thyroid
and 17P are likely to be banned from
outsourcing facilities under new FDA rules.
traditional pharmacies will be limited in how many drugs they can compound for
out-of-state patients, and doctors will be less able to order drugs for office
use in advance, patients may have to wait longer for the drugs they need.
to the regulatory favoritism of outsourcing facilities over traditional
pharmacies, more doctors will be forced to use large outsourcing facilities.
This may spark the closure of many small-scale, traditional compounding pharmacies.
are reporting that they’ve already been directed to outsourcing facilities and have
been told by traditional pharmacies that their orders can’t be filled. It seems
traditional compounders are hesitant to fill prescriptions out of fear of FDA
reprisal and are hesitant to act without finalized regulations.
Act IV: What You Can Do to Protect Your Rights
The new compounding law is now in the regulatory
phase, which means the FDA is translating it into regulations for doctors and
pharmacies. It’s critical that the integrative
health community take action to influence the new FDA rules and protect
consumer access to compounded medications.
You can act by visiting www.ANH-USA.org/compoundingproblem. Here you’ll find a quick and
easy way to send the FDA and Congress a message about how the rules will affect
your access to vital compounded medicines. Please encourage your patients to
act as well!
It’s important that we keep pressure on FDA and
Congress throughout the regulatory process, particularly since thus far, the
agency hasn’t expressed much interest in playing nice. For example, when the FDA issued
its request for information supporting their yet-to-be-created list of bulk
drug substances that may be compounded, the agency set a deadline of
three months in which to submit formal comments. Although ANH-USA
and its allies did the best they could, it was impossible to give FDA the
information they requested in such a short timeframe. In fact, we estimated it
would have taken over thirty months (15,000 hours; 1,875 business days), not
three, to properly gather the data.
In what we believe
was a direct reaction to such behavior, on May
23, the Senate Appropriations Committee
criticized the FDA for ignoring doctors, patients, and
compounding pharmacists by issuing proposed new regulations on compounding
pharmacies without sufficiently consulting the stakeholders.
ANH-USA: Your Capitol Hill Watchdogs
ANH-USA is a nonpartisan
grassroots consumer advocacy organization that protects the right of natural
health practitioners to practice, and the right of consumers to choose the
healthcare options they prefer.
Since 1992, ANH-USA has worked
to shift the medical paradigm from an exclusive focus on surgery, drugs, and
other conventional techniques to an integrative approach incorporating healthy
foods, dietary supplements, and lifestyle changes. We believe this is the way
to improve health and extend lives while returning the costs o healthcare to a
On both the state and federal
levels ANH-USA acts as a government watchdog, files comments on proposed
rulemakings, and educates the public, press, and other decision-makers. ANH-USA
is the only grassroots advocacy organization working to protect compounding
pharmacies by engaging directly with congressional decision-makers.
ANH has offices in the United
Kingdom; Atlanta, GA; and the Washington, DC, metro area. It is the largest
natural health-focused consumer group in the world.
stay up to date on the compounding issue, as well as other issues that impact the
integrative health community, subscribe to our weekly e-newsletter, The Pulse of Natural Health, at
www.ANH-USA.org. The Pulse alerts
grassroots activists to troubling laws and regulations, and provides
opportunities for action.