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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)

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