Mail-order pharmacy appeals court decision on hormones sold to Iowans

By: - March 24, 2022 11:46 am

(Photo by Getty Images)

A Texas-based pharmaceuticals company is challenging state findings that it illegally sold hormones to Iowa patients.

In 2019, the Iowa Board of Pharmacy charged Empower Pharmacy of Houston, Texas, with shipping unregulated, compounded human chorionic gonadotropin, or HCG, to Iowans in 2017 and 2018, rather than sending them the commercially available version of the product.

Typically, prescriptions for drugs are filled at pharmacies using commercially available products that have been evaluated for safety and efficacy, approved by the federal Food and Drug Administration, and are manufactured at facilities that are registered with the FDA.

When there is not a commercially available drug product that’s suitable for a particular patient, a pharmacy is allowed to compound, or manufacture, a product that has been significantly altered to meet the needs of that patient.

Since compounded products of that nature have not undergone the FDA-approval process, they lack the safety and efficacy evaluations required of commercially available drugs. For that reason, pharmacies are required to use commercially available drugs whenever possible.

The Iowa Board of Pharmacy alleged Empower bypassed that requirement and shipped to Iowans its own compounded version of HCG, which is a hormone that supports the normal development of an egg in a woman’s ovary. It is often used to cause ovulation and to treat infertility in women and to increase sperm count in men.

The board issued a warning to Empower and ordered it to permanently halt shipments of compounded HCG preparations into Iowa. In addition, the board placed the company’s pharmacy license on probation for three years and imposed a $25,000 civil penalty. It also required the company to submit reports to the board on a quarterly basis and undergo at least one on-site inspection.

Empower then went to court to challenge the board’s actions and to seek judicial review of the board’s decision. It claimed the board’s investigators chose not to interview any of the company’s pharmacists, any of the prescribing medical providers who coordinated the medications with the company, or any of the 38 Iowa patients who received the compounded HCG.

The Iowa board argued to the court that its actions were justified and noted that the pharmacy board in Oklahoma, while not taking formal disciplinary action against Empower, imposed a fine of $37,200 against the company over the compounding issue.

Polk County District Judge Celene Gogerty recently sided with board and denied the company’s request for judicial review, noting that the question before the court was whether there was substantial evidence to support the board’s findings, not whether the evidence might support a different finding.

In her ruling, Gogerty indicated the court is bound by the board’s factual findings unless a contrary result is demanded as a matter of law. There is, she ruled, “substantial evidence” to support the board’s findings that Empower violated Iowa law.  As to whether the board-imposed sanctions were reasonable and proportionate, Gogerty found that the board is primarily made up of pharmacists and said she would “defer to pharmacists’ decision on how to best sanction other pharmacists.”

Empower has now appealed that ruling to the Iowa Supreme Court, which has yet to indicate whether it will hear the case.

Compounding pharmacies like Empower are a hybrid of traditional, retail pharmacies and pharmaceutical manufacturing companies in the sense that they custom-produce medications in formulations that are then shipped directly to patients. The custom formulations enable them to forgo royalty payments they’d have to make if they simply stocked and sold FDA-approved products.

In 2019, the FDA notified Empower that the company had violated FDA regulations by failing to have on file any FDA-approved applications for new drug products it was compounding. The agency also alleged Empower violated regulations on misbranded drug products by compounding products intended for conditions that are “not amenable to self-diagnosis and treatment.”

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Clark Kauffman
Clark Kauffman

Deputy Editor Clark Kauffman has worked during the past 30 years as both an investigative reporter and editorial writer at two of Iowa’s largest newspapers, the Des Moines Register and the Quad-City Times. He has won numerous state and national awards for reporting and editorial writing. His 2004 series on prosecutorial misconduct in Iowa was named a finalist for the Pulitzer Prize for Investigative Reporting. From October 2018 through November 2019, Kauffman was an assistant ombudsman for the Iowa Office of Ombudsman, an agency that investigates citizens’ complaints of wrongdoing within state and local government agencies.