CGMP Violations at Burzynski Manufacturing

An FDA inspection at Burzynski Manufacturing Facility, Stafford, TX, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a 6/13 Warning Letter. Stanislaw Burzynski has been the subject of FDA Warning Letters and other enforcement actions at his Houston clinic since at least 2009.

The current letter says that “poor CGMP conditions at a manufacturing facility can ultimately pose life-threatening health risks to patients. This concern is particularly acute for immunocompromised patients who may receive your firm’s drug products.” Specific violations included: 

•          failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes, and failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance;
•          failing to perform operations within specifically defined areas of adequate size and that have separate or defined areas or such other control systems for aseptic processing necessary to prevent contamination or mix-ups;
•          failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination; and
•          failing to subject each lot of a component with potential for microbiological contamination that is objectionable in view of its intended use to microbiological tests before use.

The letter says that the firm’s response lacked sufficient corrective actions. “Although you indicated in your firm’s 4/10/15 response that you were developing new procedures and performing some personnel training, simply revising procedures and retraining personnel are inadequate to correct the problems described above,” the letter declares. “In sum, the violations discussed in this Warning Letter compromise the sterility assurance of your products and demonstrate significant risks to patient safety, especially because immunocompromised individuals may receive your firm’s drugs. Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements.”

Burzynski was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, along with a timetable for completion.

Warning Letters and Untitled Letters were issued to the Burzynski Research Institute in 2009, 2012, and 2013 citing violations of laws and regulations intended to protect human subjects, and use of Web sites, press releases, and embedded videos for allegedly promoting investigational antineoplastons A10 and AS2-1 injections as safe and effective for the purposes for which they are being investigated.

In 2014, the agency lifted a partial clinical hold on a Burzynski Research Institute clinical trial involving its controversial A10/AS2-1 injections. And earlier this year a federal judge ordered it to allow Burzynski to resume cancer treatments for a 20-year-old man that had been halted after a 2015 inspection found violations that again raised concerns about the safety of human patients. The judge said the treatments should continue while a full hearing is held on the FDA action.

A 2011 documentary on Burzynski and his fight against organized medicine and regulators over his cancer treatments claims that FDA and the National Cancer Institute, among other government entities, colluded with the pharmaceutical industry to protect the “cancer industry’s” profitable chemotherapy and radiation standard of care against the competitive threat of antineoplastons.