A mail-order pharmacy is taking a state licensing board to court in a dispute over the way it makes and distributes a hormone sold to Iowans.
In May, the Iowa Board of Pharmacy imposed a $25,000 penalty against Texas-based Empower Pharmacy and placed the company’s Iowa license on probation for three years. The board alleged Empower had given Iowa patients “unregulated, compounded formulations” of a hormone, rather than the commercially available version.
At issue was Empower’s practice of dispensing a specially compounded version of human chorionic gonadotropin, or 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.
Empower was alleged to be compounding HCG in a form that was essentially a copy of an FDA-approved drug. In effect, the company was alleged to be providing patients with slightly more HCG, and the bacteriostatic water used by patients to dilute it, than the commercially available product, and was then instructing patients to change the dilution to achieve the proper dosage.
That’s an issue because the FDA says compounded drugs pose a higher risk to patients than FDA-approved drugs. Compounded products are not FDA-approved, which means they have not undergone federal review for safety, effectiveness, and quality.
The FDA says it has investigated “numerous serious adverse events associated with compounded drug products” that were improperly prepared. The agency has also identified pharmacies that compound drug products under unsanitary conditions such that the drug products may have been contaminated before being shipped to patients and health care practitioners across the country.
In its decision last month, the Iowa Board of Pharmacy said Empower’s actions were precisely the type of conduct prohibited by state regulations.
Empower, which ships medications to all 50 states, now wants the Iowa courts to review the board’s decision. In a newly filed lawsuit, the company says the Iowa investigation arose from a non-disciplinary agreement the company reached with the Board of Pharmacy in Oklahoma and self-reported to Iowa regulators.
The company claims that the Iowa board, during its investigation, 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 involved. Iowa’s Board of Pharmacy was the only state licensing board to take any action against the company based on the Oklahoma case, the company contends.
Empower claims the board’s actions are arbitrary and “based upon an irrational, illogical, or wholly unjustifiable interpretation” of state law. The Iowa Board of Pharmacy has yet to file a response to the allegations.
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 2018, a Japanese pharmaceutical company sued Empower, alleging the Houston-based company “covertly” imported its patented drugs and then “peddled their knock-offs” using the Japanese company’s copyrighted packaging in order to confuse patients. Empower denied the allegations, and the case was subsequently dismissed pursuant to an agreement by all parties.
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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July 05, 2021 at 03:00PM
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Mail-order pharmacy sues state licensing board over hormone sold to Iowans - Iowa Capital Dispatch
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