Pharmacies Sue The U.S. Food And Drug Administration

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(Just Bush & Co. promoting Big Pharma as always. F )

 

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)