Varuna Srinivasan, MBBS, MPH, National Center for Health Research, April 26, 2019
Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to health professionals, patients, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
We have several concerns about the drug in question today
FDA tells us that intramuscular bacitracin is not used for its approved indication. This is because IM bacitracin has been associated with severe nephrotoxicity in young infants. Fortunately, the guidelines put forth by the American Academy for Pediatrics and the Infectious Diseases Society of America for the treatment of staphylococcus aureus in infants specify more effective and safer antibiotic therapies, such as penicillin and vancomycin.
The main question posed to the committee today is: Do the benefits of bacitracin for intramuscular injection outweigh the risks for its approved indication of the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug?
The simple and straightforward answer is no. This drug is not safe and approval should have been rescinded decades ago when it was proven unsafe for its indicated purpose.
In looking at the literature on its current use, IM bacitracin is extensively being used off-label in a variety of surgical settings to prevent surgical site infections, usually in combination with other antibiotics and antiseptic solutions. But off-label use in a different population for different purposes does not justify its continued presence on the market until those other indications are scientifically proven to have benefits that outweigh the risks. Use of antibiotics without adequate scientific evaluation of safety and effectiveness can lead to preventable harm and also contribute to antibiotic resistance.
The FDA’s mission is to protect the public from unsafe or ineffective medical products. Even when it is not popular to do so, that means holding industry accountable and requiring that companies meet rigorous approval standards to ensure that medication has benefits that outweigh the risks.
Not requiring scientific evidence to keep this product on the market would set a terrible precedent, and other companies would demand the same treatment. We urge the committee to prevent that precedent by voting to rescind approval of IM bacitracin until data are submitted establishing its benefits for another indication.