[Extensions of Remarks]
[Page E2310]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

CLAIBORNE E. REEDER, DISTINGUISHED PROFESSOR OF PHARMACOECONOMICS,
CONCERNED ABOUT FDA POSITION ON COMPOUNDING

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HON. EDOLPHUS TOWNS

of new york

in the house of representatives

Thursday, November 1, 2007

Mr. TOWNS. Madam Speaker, I would like to call my colleagues'
attention to an outstanding letter written by Claiborne E. Reeder, RPh,
PhD, to FDA Commissioner von Eschenbach, expressing grave concern about
recent FDA actions which adversely affect the compounding of
medications for individual patients which is an important part of the
practice of pharmacy. With 35 years of experience as a Pharmacist and
educator, Dr. Reeder is a distinguished professor of Pharmacoeconomics
and a nationally recognized leader in his field. In his letter, he
urges Commissioner von Eschenbach to reconsider the FDA's position on
compounding and comply with the federal ruling in Medical Center
Pharmacy v. Gonzales which recognizes that the practice of Pharmacy is
rightfully governed by the respective State Boards of Pharmacy.
Madam Speaker, I am entering Dr. Reeder's letter into the Record.

Columbia, SC,

October 19, 2007.
Andrew C. von Eschenbach,
Food and Drug Administration,
Office of the Commissioner,
Rockville, MD.
Dear Commissioner von Eschenbach: I am writing to express
my concerns about the Food and Drug Administration's (FDA)
recent actions regarding compounded medications prepared for
individual patients as part of the practice of pharmacy. The
agency's position on compounding medications, coupled with
its actions against several compounding pharmacies and its
intervention and influence on recent Centers for Medicare and
Medicaid Services (CMS) policies on compounded medications,
establishes a dangerous precedent that will affect patient
access to needed medications. Compounding medicines is an
essential component of the practice of pharmacy that provides
physicians with the opportunity to provide patients with
medicines that are prepared to the specific needs of the
individual. Compounding and preparing medications pursuant to
a valid prescription or physician's drug order has always
been and should continue to be a professional prerogative
that is governed by the pharmacy regulatory boards within
each state. Governance of the practice of pharmacy is a state
responsibility and should not be a matter for federal
intervention,
Ignoring the recent Federal court decision Medical Center
Pharmacy v. Gonzales, 451 F. Supp.2d 854, 865 (W.D. Tex.
2006), the FDA reasserted its legal position ``that all
compounded drugs are unapproved new, and therefore illegal,
drugs under the Federal Food, Drug and Cosmetic Act (FDCA)''.
Contrary to the FDA's position, the Federal Court held that
``compounded drugs, when created for an individual patient
pursuant to a prescription from a licensed practitioner, were
implicitly exempt from the new drug definitions contained in
the Act''. The Federal Court seems to understand the issue
very clearly and recognizes that medications compounded for
individual patients pursuant to a valid prescription are not
``new drugs'' and are therefore not under the purview of the
FDCA or the FDA.
As a pharmacist/educator with 35 years of experience, I
appreciate the FDA's concern for quality, safety and efficacy
of medicines. That said, I also know that pharmacists are
educated and trained in the ``art and science'' of pharmacy
which includes compounding medicines for patients who need
them. The broad interpretation ``that all compounded drugs
are unapproved new, and therefore illegal drugs'' is a
very slippery slope of regulatory intrusion on the
practice of pharmacy as is FDA's practice of exercising
its enforcement discretion through reliance on the 2002
Compliance Policy Guide, Section 460.200. Many patients
have medication needs that are unmet by commercially
available products. Patients often require a particular
strength or dosage form of a drug that is not available on
the market. Also, commercially available products may
contain additives or excipients to which the patient is
allergic or intolerant. To declare compounded medications
illegal is to deny these patients access to needed
medicines.
Compounding medicines is not limited to the typical
community environment. Hospitals, skilled nursing facilities,
and specialty pharmacy providers prepare medications to order
as part of their daily practice. Do the FDA and CMS positions
mean that preparation of parenteral and enteral solutions as
well as other extemporaneous products, within these settings
is no longer legal? If not, then a disparity is created.
To further illustrate the consequences of the Agency's
position on compounding, CMS, without explanation or medical
rationale, reversed its long standing policy on inhalation
medications by excluding compounded inhalation medications
for Medicare beneficiaries stating that they were no longer
``medically necessary''. This new CMS policy, based on FDA's
position, may have far-reaching and serious consequences fur
Medicare beneficiaries who rely on nebulizer medications.
Eliminating compounding will severely restrict access to
these and other critical medications for Medicare
beneficiaries. Moreover, the policy will limit physicians'
abilities to prescribe the medicines in the strengths,
formulations, and routes of administration that are best for
patient care.
I am asking that the FDA to reconsider its position and
comply with the Federal court ruling. The practice of
pharmacy is governed by the respective state Boards of
Pharmacy through the powers granted by their legislatures.
Compounding is an integral part of the practice of pharmacy
and should thus fall under the governance of the profession
at the state level.
Thank you for considering my comments in this matter. If
you or anyone at the FDA would like to discuss this issue in
more detail, I would be delighted to do so.
Sincerely,
Claiborne E. Reeder,
Distinguished Professor of Pharmacoeconomics.

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