tussle between a Texas compounder and the Food and Drug Administration underscores the ongoing difficulties that regulators can have overseeing this controversial portion of the medical supply chain.
The episode also illustrates how varying approaches taken by state and federal authorities to regulating compounding pharmacies can leave doctors and patients confused about the safety of medicines.
Here’s the back story: Last month, the FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but the compounder refused an agency recommendation to halt production or issue a recall until the problems were fixed.
The FDA, which is not aware of any side effects attributed to the drugs, lacks authority to force the compounder to take these steps. Meanwhile, though, the medicines, which are injected or infused, remain available.
So earlier this week, Public Citizen, the consumer advocacy group, urged the Texas State Board of Pharmacy to suspend the compounder’s license. The FDA “uncovered multiple egregious, life-threatening problems in the company’s processes for making sterile drugs,” the advocacy group wrote to the state regulatory agency.
However, the Texas State Board of Pharmacy is declining to do so.
Why? In response to the FDA actions, the state agency sent its own inspector to review IV Specialty facilities. But “our inspector was comfortable that there wasn’t an immediate danger to the public,” Gay Dodson, the board’s executive director, told us. “According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down.”
She noted that state regulations are not as stringent as FDA regulations. This is not to say the state agency has given IV Specialty the proverbial clean bill of health. Her office issued five warning notices last month to the compounder for different violations, but is awaiting a response by April 24. Dodson added that her agency is also “working with the FDA.”
The incident underscores the unsettled approach to government oversight of compounders in the wake of a scandal in 2012. In that instance, injectable steroids made at the New England Compounding Center were linked to 64 deaths and more than 750 cases of fungal meningitis around the country. The episode cast a harsh spotlight on compounders and FDA oversight.
In response, the Drug Quality and Security Act was passed and beefed up FDA authority to inspect facilities and enforce regulations. In some ways, though, the effort remains a work in progress.
“We’re still in the early stages of figuring out how state and federal regulation schemes are going to work,” said Elizabeth Jungman, director of public health programs at Pew Charitable Trusts, which tracks compounding issues. “So it’s confusing for patients and physicians to see disagreement between regulators at state and federal levels.”
A Pew analysis issued two months ago found that state oversight of compounders is a spotty patchwork of regulations. Only about half of the states require compounding pharmacies that make sterile medicines to fully comply with recognized quality standards.
Meanwhile, Public Citizen points out that the Alabama Board of Pharmacy last month ordered a compounding pharmacy to halt production shortly after the FDA inspected its facilities and found safety problems.
As for IV Specialty, this was not the first time that the FDA cited it for quality control issues. The agency sent a warning letter last year after an earlier round of inspections.
Carlos Garcia, the pharmacist at the compounder, wrote us that IV Specialty is upgrading facilities, including its clean room and sterility testing procedures. “With these steps in place, we are confident we can provide a sterile product while our clean room is awaiting upgrades,” he wrote us. He added that none of its products ever failed a sterility test.
He also said that IV Specialty is a “small, local pharmacy” that only mixes medicines in response to a physician order and does not provide medicines at a later date or for use in a physician’s office. The compounder, he also noted, does not ship medicines to other states.