FDA Issues Warning Letter to Johnson & Johnson
Today we’d like to announce the launch of the Friends of Médecins Sans Frontières
National Essay Competition 2009-10, which will be a great chance to engage with and write about anything you care about to do with humanitarian work. Entries will be judged by a panel from MSF and our very own Rhona MacDonald. The competition deadline is January 8th 2010 and full details of the competition including the catagories, prizes and how to enter can be found here. Good luck!
The FDA’s investigation of the trial revealed that it had not been properly monitored, nor had thorough records been kept
The US Food and Drug Administration (FDA) has issued a warning letter to the pharmaceutical company Johnson & Johnson regarding the Phase III trials of a new drug. The letter announced the delay in the FDA’s approval of the drug ceftobiprole due to concerns of improper practice during the clinical trials which endangered the health and welfare of the participants.
Ceftobiprole is a member of the cephalosporin class of antibacterial agents, developed to treat complicated skin and skin structure infections (cSSSIs) resulting from abscesses such as diabetic foot. While ceftobiprole can treat a wide range of bacterial infections, its major strength was that it was effective against methicillin-resistant Staphylococcus aureus, more commonly known as the ‘super-bug’ MRSA. As of 2003, MRSA made up 60% of hospital S. aureus infections in the USA, so effective means to treat it are highly prized. Analysts predicated J&J could make nearly $500 million from ceftobiprole in 2010 alone, but now the drug may have to wait a long time before it is approved for sale.
The FDA’s investigation of the trial revealed that it had not been properly monitored, nor had thorough records been kept. Despite ascertains that the drug would be administered in a controlled environment, it was found that some patients had been self-medicating in their homes, which had also resulted in improper storage of the drug. The study was also found to have been improperly blinded, with the doses being prepared by the nurses who administered them and cared for the patients rather than a pharmacist who would be unaware of who was receiving the drug and the placebo. More seriously, the administration of the drugs was sometimes delayed, which could have resulted in the primary infection getting worse, or even the onset of sepsis and death. As well as responding to these concerns, the FDA letter asked J&J to establish procedures in any ongoing or future trials to make sure these mistakes are not repeated.
The drug’s development has been further complicated by a damages case from the Swiss company Basilea Pharmaceutica AG, from whom J&J licensed ceftobiprole. The basis of the ongoing case is that J&J have failed to gain FDA approval for the drug and also allegedly failed to fully develop it as a possible treatment for pneumonia.