Huge Legal Win for Compounding Pharmacists

It is a welcome outcome when the judicial system issues a ruling that helps solve a medical problem rather than compounding or creating a new one. An Association of American Physicians and Surgeons' "News of the Day in Perspective" release on May 28, 2006 notes such an occurrence.

Tens of millions of Americans take customized preparations prescribed by physicians and mixed by compounding pharmacies instead of mass-produced, FDA-regulated drugs. These include hormones, topical creams for nausea, dermatologic and ophthalmologic preparations, and pain medication.

In a landmark ruling, U.S. District Judge Rob Junell in Midland, Texas, ruled that customized compounds created by compounding pharmacies are not new, unapproved drugs that must be sanctioned by the U.S. Food and Drug Administration. AAPS assisted by filing two amicus briefs in support of the compounding pharmacies in the case 'Medical Center Pharmacy v. DOJ, HHS, FDA.'

Austin lawyer Terry Scarborough, who filed the lawsuit against the FDA on behalf of 10 pharmacists, praised the decision: "We are pleased the court ruled from the bench on the most important issue - that compounds don't create 'new' drugs as the FDA suggested." Scarborough said that Judge Junell indicated he would issue an injunction barring FDA inspections that exceed its authority. Kristie Zamrazil, a spokeswoman for the Texas Pharmacy Association, said the decision preserves the roots of pharmacy. "Compounding has been part of pharmacy practice since its origins. Judge Junell's ruling is a win for patients and recognizes the important health-care service that pharmacists have provided through the ages." (Lavlan Copelin, Austin American-Statesman 5/27/06)

Ken McLain is a pharmacist for the Sav-On pharmacies in Orange County, Calif. While the drugstore he serves in Newport Beach no longer does much compounding, he notes that a ruling against compounding would have had significant detrimental effects upon patients and health care. "There are a number of pharmacies that specialize in compounding that provide needed medicines for many patients. Often patients have specialized needs such as requiring higher/lower doses of a medication or have allergies to filler materials or certain drugs. "Pharmaceutical companies are not able to provide or manufacture pills, tablets, lotions or creams for every known disease, illness or injury. Many patients are extremely dependent on the skills of the pharmacist."

A new drug is subject to the FDA's onerous new drug application process, stated AAPS General Counsel Andrew Schlafly, who filed an amicus brief for the pharmacists.

According to this ruling, "Compounded drugs are fully legal and not subject to the requirements and prohibitions imposed on new drugs by the 1938 Food, Drug and Cosmetic Act," Schlafly further notes. Adds AAPS Executive Director Jane Orient, M.D., who has a way of cutting through the camouflage: "Compounding pharmacies could not possibly meet the onerous, expensive and time-consuming FDA requirements. "They make prescriptions one at a time. The FDA requirements are designed for manufacturers who make pills by the billions. Ophthalmologists and dermatologists - and their patients - would be especially hard hit. The products their patients need are not available except from compounding pharmacies."

In an era of mass impersonal medical care controlled by insurance companies and government, and with professional relationships worsened by trolling trial lawyers, patients are crying out for some personal care. Ideally, specialized care should be the goal of the future. Why take the art out of the art and science of pharmacology? Pharmacists are well trained professionals who significantly add to health care in a one-on-one relationship.

An unwise judicial ruling would have relegated them to pouring pills from many large white bottles to smaller clear ones. It is indeed a rare day in June when a legal or judicial man makes a decision that contributes to better health care. So kudos to Texas Judge Rob Junell. A written order to make this wise ruling binding will be issued in late July.

Source

***************************

For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

Comments? Email me here. If there are no recent posts here, the mirror site may be more up to date. My Home Page is here or here.

***************************