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PHARMACIES SUE THE U.S. FOOD AND DRUG
ADMINISTRATION
Lawsuit Contends Agency’s Actions
Ignore Precedent, Violate Federal Law, Limit Patient Treatments, and
Threaten the Quality of Health Care for Millions.
Article
by Steven F.
Hotze, MD and Carol Petersen, RPh
September 27th, 2004
Midland, Texas
– A coalition of pharmacies from Texas, Arizona, Alabama, Wisconsin,
California and Colorado today filed suit against the U.S. Food and Drug
Administration (FDA) claiming the agency is illegally enforcing an
arbitrary regulation it never had the authority to issue. The group is
also asking the federal court to order the FDA to adhere to the intent
of Congress that pharmacies be controlled by their respective state
boards of pharmacy. The court is being asked to protect law abiding
pharmacists from unlawful inspections, illegal interventions and
intimidations by the FDA of state-regulated pharmacies which are
following decades-old laws enacted to ensure the best health care for
patients and pets.
The
compounding of medications from bulk ingredients for individual
patients, as prescribed by a physician or veterinarian, is the historic
practice of pharmacy and has been occurring since the inception of the
profession of pharmacy, centuries ago. Drug compounding is the process
by which a pharmacist combines, mixes, or alters the mode of
administration of ingredients to prepare a medication, prescribed by
a physician or veterinarian, tailored to an individual patient’s
need. The practice of drug compounding is also known as compounding
pharmacy. Compounded medications may be prescribed to patients for
personal use or may be dispensed to the physician or veterinarian for
discretionary treatment of patients at a medical facility.
Ten compounding pharmacies have petitioned Judge Robert A. Junell of the
U.S. District Court for the Western District of Texas to be able to
continue filling prescriptions from doctors and veterinarians using pure
“bulk ingredients” that are manufactured in FDA-registered, inspected,
and approved facilities. Last year,
the FDA issued a
compliance policy guideline (CPG
7125.40 Section 608.400)
which suddenly made the use of
bulk ingredients in
the preparation of medications for pets and companion animals illegal.
The agency has since waged an aggressive inspection campaign to enforce
the CPG.
Pharmacies are governed and licensed by their respective State Boards of
Pharmacy. The Food and Drug Administration (FDA) has no authority over
any pharmacies, whether they compound preparations or not. Federal
statutory mandates contained in 21 U.S.C. § 360 (g)(1) and Section 374
(a)(2)(A) exempt pharmacies from jurisdiction by the FDA.
“The
FDA’s unlawful actions are meant to intimidate law abiding pharmacists
to quit compounding medications. If the FDA is successful, then this
would deprive veterinarians and physicians of critical treatment options
that relieve the suffering of their patients and improve their health,”
said Steven F. Hotze, M.D., President of Premier Pharmacy in Katy,
Texas. “Many safe, legal medications which are not produced by
drug companies would cease to exist without the highly specialized and
closely regulated work of compounding pharmacies. Without being able to
use bulk ingredients to prepare the medications prescribed by
practitioner’s, compounding pharmacies would not be able to meet the
medical needs of millions of patients.
The coalition’s case against the FDA has three parts: first, although
the FDA acknowledges in the CPG that the CPG is not a law and cannot
impose any obligations, the FDA continues to act as though the CPG were
law; second, federal law specifically exempts any pharmacy that complies
with state regulations from FDA jurisdiction; and third, the FDA’s
current course of action directly contradicts what it argued in
Thompson v. Western States before the U. S. Supreme Court, that
compounded drugs like those in question could not be treated as “new
drugs.” The highest court in the land adopted this view in the
Western States ruling.
Since
1962 the U.S. Congress has recognized and has specifically protected the
special role that pharmacies, including compounding pharmacies, play as
partners in the doctor-patient relationship. Drug compounding for
humans and non-food animals, in fact, has depended on bulk ingredients
for over a century. Compounding continues to be a required discipline at
every pharmacy school in the country as well as a required proficiency
in every state.
“The vast majority of Americans reject a one-size-fits-all approach to
their health care,” said Carol Petersen, RPh, Director of Pharmacy
Operations of Women’s International Pharmacy in Madison, Wisconsin and
Pet Health Pharmacy in Youngtown, Arizona. “As the world’s most
developed nation, we deserve the greatest degree of choice and quality
in our health care – and the thousands of compounding pharmacists
operating around the country today remain an essential ingredient in
that formula.”
The pharmacies joining the lawsuit are: Medical Center Pharmacy in
Midland, Texas; Applied Pharmacy in Mobile, Alabama; College Pharmacy in
Colorado Springs, Colorado; Med Shop Total Care Pharmacy in Longview,
Texas; Pet Health Pharmacy in Youngtown, Arizona; Plum Creek
Pharmaceuticals in Amarillo, Texas; Premier Pharmacy in Katy, Texas;
Veterinary Pharmacies of America in Houston, Texas; University Rx
Specialties in San Diego, California and Women’s International Pharmacy
in Madison, Wisconsin.
The coalition recently created a legal defense fund, and in just a few
weeks have already raised over half the projected $1.5 million needed to
defend the rights of law abiding pharmacies in court. Representing the
coalition in this legal battle are lead national counsel Howard M.
Hoffman in the Chicago, Illinois office of Duane Morris LLP, one of the
top 100 law firms in the United States, and lead local counsel Terry
Scarborough of Hance, Scarborough, Wright, Woodward and Weisbart, a law
firm based in Austin, Texas.
Mr. Hoffmann is a
highly experienced trial lawyer and appellate advocate, as well as
a former
Assistant United States Attorney with the U.S. Attorney's Office for the
Northern District of Illinois in Chicago where he served as chief of the
Criminal Division. Mr. Hoffmann was the lead counsel for a group of
compounding pharmacies before the U.S. Supreme Court in the
Thompson v.Western
States
case. A decision in this case was issued by the U.S. Supreme Court in
April 2002 declaring as unconstitutional the section of the 1997 Food
and Drug Administration Modernization Act which dealt with compounding
pharmacies.
Mr. Scarborough has a 32-year career as a litigator in state and federal
courts, in arbitration, and before administrative agencies. From 1971 to
1973, Mr. Scarborough served as an Assistant District Attorney for
Travis County, and he has prevailed in his private practice before the
various Texas appellate courts and the Fifth Circuit.
Steven F. Hotze, MD (281.698.8679),
and Carol
Petersen, RPh (800.699.8144)
This
"Millions of Health Freedom Fighters - Newsletter" is about the battle
between "Health and Medicine" on Planet Earth. Tim Bolen is an op/ed
writer with extensive knowledge of the activities of a subversive
organization calling itself the "quackbusters," and that organization's
attempts to suppress, and discredit, any, and all health modalities that
compete with the allopathic (MD) paradigm for consumer health dollars.
The focus of the newsletter is on the ongoing activities, battles,
politics, and the victories won by members of the "Health Freedom
Movement" against the "quackbusters" It details "who the quackbusters
are, what they are, where they are operating, when they appear, and how
they operate - and how easy it is to beat them..."
For background information on the "Battle
between Health and Medicine" go to:
http://www.savedrclark.net/by_whom2.htm. A copy of THIS newsletter,
and older ones, are viewable at the website
http://www.quackpotwatch.org/default.htm.
For EVEN MORE interesting and related
articles go to
http://www.bolenreport.com.
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