A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the FDA’s crosshairs for the second time in less than a year.
The FDA has slapped Empower Pharma with a warning letter citing a laundry list of production issues that put the company in violation of its 503B compounding credentials under the Federal Food, Drug, and Cosmetic Act. The FDA delivered the warning letter at the beginning of April following an inspection of Empower’s Houston manufacturing facility last August.
Empower initially received the less severe consequence of a Form 483 and started a recall of certain products made at the facility following the FDA’s inspection last summer. That said, the company was also taken to task by the FDA over similar infractions last May.
Repeated lapses on the company’s part “demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the FDA said in its warning letter, which was posted to the agency’s website April 22.
Digging into the FDA’s concerns, the agency noted that drug products from Empower’s facility lack key labeling information, including how to report side effects and directions for use such as dosage and administration.
By failing to include those crucial details on its packaging, Empower ran afoul of the rules for 503B compounding, which allow outsourcers to produce bulk batches of drugs without needing to go through the formal FDA approval process. That said, 503B compounders are still held to industry manufacturing standards and must meet other requirements to stay in compliance with the FDA.
Labeling aside, FDA inspectors also noted that Empower-produced drugs that should have been sterile were prepared, packed or held in “unsanitary conditions” that could have led to contamination.
To make its point, the FDA went through a litany of production shortfalls observed at the Empower facility.
The compounder failed to assess and respond appropriately to a microbial contamination event; it dropped the ball on performing satisfactory smoke studies to demonstrate proper airflow in manufacturing spaces; it didn’t follow up thoroughly when production results were out of spec; and the company lacked proper protocols for maintaining equipment, ensuring a consistent manufacturing process and monitoring environmental conditions in aseptic areas, the FDA said.
Despite the prior wrist slap in the shape of a Form 483, Empower’s efforts so far to right the ship at its facility have failed to impress the FDA, which called some of the corrective actions the company has taken in the previous year “deficient.”
The regulator noted that, among other issues, Empower failed to provide an adequate product impact assessment for a certain batch of its drug pyridoxine HCL—which was subject to a recall in September—after the company released the batch despite detecting positive microbial growth in the area the product was produced.
Complicating matters further, the FDA noted that it was “unable to fully evaluate” Empower’s proposed corrective actions because the company failed to furnish the agency with enough documentation.
Given the scope of Empower’s infractions, the FDA is recommending that the compounder launch a comprehensive assessment of its operations, including facility design, procedures, personnel, processes, maintenance and more. The regulator stressed that Empower specifically needs to get its aseptic processing operations under control and urged the company to enlist third-party sterile manufacturing expertise.
Although compounded tirzepatide was not listed among the multiple Empower products flagged in the warning letter, the company is one of many locked in a duel with Eli Lilly over the continued practice of compounding GLP-1s.
Compounding pharmacies have filled a major supply gap in recent years as both Lilly and Novo Nordisk, which makes semaglutide, struggled to keep up with the immense demand for their anti-obesity and diabetes meds.
Still, the FDA’s determination that the shortage of Lilly’s diabetes and obesity offerings—marketed as Mounjaro and Zepbound—has ended set a March 19 deadline for many 503B outsourcing facilities to stop compounding tirzepatide.
Lilly accused Empower of flouting that deadline in a recent lawsuit, in which it contended the outsourcer was falsely advertising its compounded tirzepatide as a personalized version of Lilly’s patented drug.
At the time, Empower cautioned against cutting off access to personalized alternatives for popular drugs and said it was “committed to offering these life-changing formulations” in a statement to CNBC.