Good afternoon. My name is Dr. Laurén Doamekpor, and I am a senior fellow at the National Center for Health Research. Thank you for the opportunity to speak today. Our non-profit research center assesses scientific and medical data and provides objective health information to patients, providers and policy makers. We have great respect for the FDA, which is why our center’s president is on the Board of Directors of 2 nonprofit organizations focused on providing additional resources to the FDA: the Alliance for a Stronger FDA and the Congressionally mandated Reagan-Udall Foundation. We do not accept funding from drug companies therefore I have no conflicts to disclose.
We are all aware of the important role that OTC antiseptics play in reducing the risk of infection, particularly in the healthcare setting. That is why it is crucial to ensure that the ingredients in these products are as safe and effective as possible.
In our review of the FDA’s proposed safety framework, we were encouraged to see that many of the studies that the FDA proposes to support a GRAS determination for an OTC antiseptic active focus on the right questions. We agree that it is important that studies address the degree of human absorption, metabolic rates and carcinogenic effects. However, considering that many healthcare antiseptics are used more than once, and in many cases for extended periods of time, it is important that studies be conducted for long enough periods of time to establish the real world effect of these ingredients.
Based on the FDA’s proposed framework, the summary of the available data for the healthcare active ingredients shows that there are many unanswered questions about the safety of the healthcare antiseptic drug products. In fact, for some of the ingredients, close to nothing is known. This concerns us, and I’m sure it concerns you as well.
For example, even though alcohol is commonly used in antiseptic products in the healthcare setting, but only some data are available about human absorption. In some cases, such as benzalkonium chloride, the only data available are on bacterial resistance, not safety issues.
Hospital-acquired infections are a major killer in the U.S. today. Without more data, patients are at risk for infections, adverse reactions, and death.
We are particularly concerned about pregnant healthcare workers who may be exposed to some of these antiseptic ingredients several times during their pregnancy. Since many of these ingredients lack important safety data, there must be additional warnings provided on these products for women who are pregnant or breastfeeding.
As you continue your discussion today, please keep these unanswered questions in mind. Patients’ health and safety should be at the forefront of this meeting.