Biogen Idec may impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex.
A recent inspection report issued by the FDA, which examined a facility last summer, noted that the drugmaker did not always challenge the validity of all testing results provided in certificates of analysis as part of qualification procedures. In other words, Biogen (BIIB) did not always ensure that active pharmaceutical ingredients were sterile, as suppliers claimed.
In addition, Biogen did not adequately or completely document control procedures to demonstrate that procedures are followed, and the FDA found at least one questionable instance concerning cleaning and sanitizing. READ MORE