FDA
8th September 2014

FDA Panel Comments on Safety for Topical Antiseptics & OTC Sunscreens

On September 3rd, the Nonprescription Drugs Advisory Committee (NPDAC) met to discuss the safety and effectiveness of over-the-counter (OTC) topical antiseptics used in healthcare settings.

FDA Panel Comments on Safety for Topical Antiseptics & OTC Sunscreens

On September 3rd, the Nonprescription Drugs Advisory Committee (NPDAC) met to discuss the safety and effectiveness of over-the-counter (OTC) topical antiseptics used in healthcare settings. The discussion focused on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. New minimum safety data standards for these antiseptics were discussed as well as the possible re-categorization of three commonly used topical antiseptics.

During this meeting, NPDAC voted unanimously (12 to 0) to recommend that the staff members go ahead and propose new safety standards for 11 common over-the-counter healthcare antiseptic ingredients;

Alcohol, isopropyl alcohol, povidone-iodine, iodine tincture, and iodine aqueous solution (classified as GRAS/category 1) and benzalkonium chloride, benzethonium chloride, chloroxylenol, hexylresorcinol, triclocarban, and triclosan (classified as insufficient data to classify/category 3).

Importantly, FDA staff members noted at the meeting that although the products were initially classified as safe when they were introduced to market, new data have emerged, as well as the sophistication of scientific product testing which warrant new proposed safety data standards.The substances are regulated according to the FDA’s monograph process rather than under the agency’s drug approval process. Under that process, over-the-counter drug products are subject to a “rule book,” overseen by FDA staff and approved by the FDA commissioner, and are not subject to review and approval by the FDA overall.

For the next couple of days, NPDAC discussed the scope of safety testing (i.e. long-term safety data, clinical and nonclinical) that should be required for sunscreen active ingredients to be marketed in OTC sunscreen products in the United States.  

During this meeting, NPDAC discussed the increasingly important concern of sunscreen safety, as they are intended to be applied over the entire body, multiple times a day, and essentially for a lifetime. Because of this reality, NPDAC’s discussion focused on the need for manufacturers to provide more long-term safety data and information on how the active ingredients affect the health of special populations including infants, children, the elderly, and those with skin conditions.

At the meeting, a coalition of sunscreen manufacturers spoke, stating that most of what was being requested by the FDA is redundant or not necessary. The Personal Care Products Council (PCPC) noted that many of today’s sunscreen ingredients had been used for decades, without any indication that they caused cancer or led to any significant safety issues and that “today’s sunscreen ingredients have a wealth of data to support their safety.”

Furthermore, some, including Dr. David J. Margolis, professor of dermatology at the University of Pennsylvania, Philadelphia, were concerned not only the safety of sunscreen over the long-term, but also potentially too much reliance on rodent model. Dr. Margolis stressed that, “the penetration through rodent skin is different than the penetration through human skin.”

Dr. Marissa J. Perman, a pediatric dermatologist at the Children’s Hospital of Philadelphia who spoke during the public session, said that the agency should also consider requiring studies in pregnant and lactating women.

Actual use patterns versus directed use were also discussed among panel members. Several panelists said that they were concerned about the disconnect between real-world use of sunscreen and the directed use that is studied during trials.

Some committee members went as far as to say that they viewed sunscreens as drugs that should always be subject to the same review and approval process

The FDA is not required to follow the panel’s advice. Any change to how sunscreens are regulated would require issuing a new rule and going through a public comment period. An FDA official declined to say when that process might occur.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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