A little more than a month after the US Food and Drug Administration (FDA) was overruled by a judge to allow a college student with terminal cancer to re-start a clinical trial, in which he’s the only patient, FDA has issued a warning letter to the manufacturing facility linked to the trial, noting serious current good manufacturing practice (CGMP) violations.
The concerns from FDA in the warning letter, sent on 13 June and released Tuesday, followed the agency’s 10-day inspection in March 2015 that found a lack of sterility protections for manufacturing the experimental treatments and a lack of assurance that the manufacturing process is even adequate to ensure the treatment the patient is expecting to receive is the treatment he receives.
“Your firm failed to ensure that the [redacted] you use to manufacture your drug product was adequate for [redacted] drug manufacture,” the letter says. “Your firm prepares [redacted] using an [redacted] system that lacks adequate qualification, validation, maintenance, and monitoring to ensure [redacted] of suitable quality…Your lack of robust design, control, and monitoring increases the risk of impurities (including endotoxins) in the [redacted] your firm uses in sterile [redacted] drug manufacturing."
The warning letter comes as FDA has been entangled in a struggle to shut down the Texas doctor, Stanislaw Burzynski, for decades and most recently as he’s re-started his so-called trial for Neil Fachon, an engineering student at Northeastern University, who’s diagnosed with the terminal DIPG (Diffuse Intrinsic Pontine Glioma), which has no currently available treatments.
Burzynski, who runs the manufacturing site and clinic, has numerous critics who say he scams terminally ill patients with experimental treatments that have not only never proven to be effective in clinical trials but which Burzynski has no intention of ever bringing to market and that cost patients significant amounts out of pocket.
In late 2013, FDA went after Burzynski with another warning letter, chiding him for failing to adhere to clinical trial regulations, though those concerns were not mentioned when a judge ruled on 18 May to overturn FDA’s decision on halting the most recent iteration of this trial and allowing it to continue.
The latest warning letter for Burzynski also explains: "We reviewed your firm’s response received on April 10, 2015, in detail and note that it lacks sufficient corrective actions. Poor CGMP conditions at a manufacturing facility can ultimately pose life-threatening health risks to patients. This concern is particularly acute for immunocompromised individuals who may receive your firm’s [redacted] drug products…When our investigators asked for your environmental monitoring documentation, the only documentation you could provide for the ISO 7 support rooms surrounding the aseptic processing room was from 2005."
Burzynski did not respond to a request for comment.
FDA is requesting a response within 15 days from the facility as “there are inherent flaws in your facility design that promote the influx of poor quality air into the aseptic processing (ISO 5) zone where the sterile product is exposed. These and other conditions observed at your firm anddiscussed in this Warning Letter create contamination hazards that cannot be adequately addressed by changes to procedures and training of the type you propose.”