- The Washington Times - Thursday, October 19, 2006

The Bush administration is cracking down on pharmacies that mass manufacture their own versions of commercial drugs, fearing that the practice poses a serious health risk to consumers.

The Food and Drug Administration (FDA) recently issued warning letters to three large medical equipment companies, RoTech Healthcare Inc., CCS Medical and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded inhalation drugs nationwide.

FDA inspectors found that the companies were producing commercially available drugs illegally, sometimes with higher dosage levels.

The pharmaceutical practice known as compounding has evolved from crushing tablets into liquid for children to mass manufacturing heart and blood pressure medications.

Though the FDA has not attributed any fatalities to a compounded medication, the government says compounded drugs pose unnecessary health risks and is attempting to slow the practice by requiring that compounded drugs, which are not recognized as safe and effective, be approved by the FDA.

“Products are being compounded that we never thought would be,” said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.

For example, companies are investing in natural hormone replacement treatments as an alternative to commercially available hormone replacement treatments, which use artificial ingredients. Compounded hormone replacement treatments use bio-identical hormones that mimic the body’s natural hormones such as estrogen. Critics of bio-identical hormone replacement treatments say women are taking an experimental, unproven treatment.

Profit margins for compounded drugs can reach hundreds of millions of dollars. Last year, Health Sciences Group Inc., a provider of nutritional products, announced that it expanded its pharmaceutical operations to offer compounding services to independent pharmacies. At the time, John Park, vice president of the company said gross margins for compounding can range from 50 percent to 80 percent.

Legitimate pharmacy compounding is an age-old practice, and occurs when a patient needs a medication that is not commercially available. Pharmacists modify a drug to fit the patient’s specific needs such as converting tablets to liquids or individualizing dosage levels.

But in its most pernicious form, pharmacies and medical equipment companies mass produce drugs that resemble commercial drugs. Compounded drugs are not approved through the FDA; rather, state pharmaceutical boards have the primary oversight role for compounding pharmacies.

New drugs go through a rigorous FDA approval process and can take years before they are introduced to the market. State pharmacy boards may not have the resources to ensure a compounded drugs’s safety.

Sarah Sellers, a pharmacist specializing in sterile compounding and former member of a federal advisory committee on pharmacy compounding, said contemporary compounding represents an emerging drug industry that exploits loopholes in the law and the resource constraints of federal regulators.

“Compounded drugs are produced outside our federal regulatory framework and carry risks of contamination. Complete and unbiased information on the size and scope of the industry has not been generated,” Ms. Sellers said.

Pharmacies won the latest skirmish over regulating compounded drugs when 10 pharmacies took the Bush administration to court over the FDA’s attempt to restrict compounding. In an Aug. 30 ruling, Judge Robert Junell ruled that compounded drugs cannot be considered new drugs that must be approved by the FDA. Also, Judge Junell said state pharmaceutical boards — not the federal government — have jurisdiction over pharmacy compounding.

The favorable ruling for pharmacies ensures, for now, that compounded medications are not subject to the FDA’s approval process for new drugs. The agency maintains that the mass manufacturing of compounded drugs is subject to its oversight.

“The case is crucial to establish that compounding is not subject to the law that new drugs must be approved by the FDA,” said L.D. King, executive director of the International Academy of Compounding Pharmacies. “State boards do a great job regulating compounding pharmacies.”

The FDA countered that the judge’s ruling should be amended. The agency is considering all of its options, including appealing the decision, said FDA spokeswoman Susan Cruzan. The ruling must be appealed by Oct. 30.

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