FDA approves use of glycolic acid and TCA in compounds following AAD testimony

In November, Seemal R. Desai, MD, FAAD spoke on behalf of the American Academy of Dermatology Association (AADA) and the American Society of Dermatological Surgery Association (ASDSA) at the FDA Pharmacy Compounding Advisory Committee (PCAC) meeting. He testified during the open public hearing in support of adding glycolic acid, trichloroacetic acid (TCA), and kojic acid to the Section 503A bulk drug substances list. Dr. Desai talked to Member to Member about the outcome of his testimony.

MTM: What was your testimony at the FDA?

seemal-desai.jpgDr. Desai: The issue right now with the FDA and dermatology is compounding and the use of compounded medications, which we use a lot of in dermatology because many of our medications are off-label and require a lot of ingredients.

Specifically, I testified during the open public hearing in support of adding glycolic acid, trichloroacetic acid (TCA), and kojic acid to the Section 503A bulk drug substances list. If an ingredient is considered for addition to the list and the FDA does not ultimately add it to the list, then physicians and pharmacists will no longer be able to compound it.

For dermatology, we have these three very important ingredients that we use often in pigmentary disorders, in skin of color, and for photo damage and anti-aging. These medications need to be on the compounding list so that they can continue to be compounded at the pharmacy level either in a topical cream for patients to use at home, or in an in-office preparation where we’d use it in chemical peels, mesotherapy, or in direct application to the skin.

We were very fortunate that the committee unanimously voted to keep glycolic acid available. And we had a 7-1 vote in favor of keeping TCA.


MTM: How did the FDA receive the message?

Dr. Desai: The FDA was very impressed that I was there and was offering joint testimony on behalf of AADA and the ASDSA. Believe it or not, this was the first time that the societies did a joint testimony at an FDA federal hearing.

I was the only physician there testifying. The others in attendance represented pharmacy compounding, who have a vested interest in protecting these ingredients for pharmacists.

The way it works is that the FDA presents their background data, the science, the physiology, the chemical makeup, the side-effects, and the data on each of the ingredients to the PCAC. During the public hearing, I was allowed to make comments on the FDA’s presentation to the PCAC. I explained why it was important for us to continue to have access to the ingredients.

We were very fortunate that the committee unanimously voted to keep glycolic acid available. We had a 7-1 vote in favor of keeping TCA. The FDA will consider the PCAC vote in its notice-and-comment rulemaking process for finalizing the Section 503A bulk drug substances list, which is expected to take place within the next couple of years.

However, we narrowly lost the approval of kojic acid.

The FDA’s position is that at a molecular level, kojic acid is very unstable. My argument was that compounding pharmacies can actually use the ingredient to make it into a stable formulation for topical use. And these formulations are for short-term use. So long-term stability is not really an issue. Before my argument, the committee members were all planning on voting against adding kojic acid to the compounding list. But members of the PCAC expressed appreciation of my testimony and a result, I was able to get three votes from the “nay” column to the “yay” column, and one abstention.

Even with that loss, it was a big win for the specialty.

Kojic acid may be ultimately not included on the finalized list because of this vote. However, the FDA is not required follow the PCAC vote. So, it’s not a lost cause for kojic acid. The AAD will continue to advocate to get kojic acid included.

You don’t have to specialize in pigmentary disorders to recognize the value in kojic acid. A lot of aesthetic dermatologists and our cosmetic colleagues use it for sunspots, photo damage, and photo aging because it’s an alternative to hydroquinone in terms of skin lightening. Although hydroquinone is the gold standard, hydroquinone can have side-effects. And that was my argument to the FDA. If they take away kojic acid, I have one less medication that I can offer a patient who needs to be off hydroquinone and still get some skin lightening and skin tone benefits.

MTM: What can members do to help the compounding advocacy efforts?

Dr. Desai: Whenever the Academy sends alerts for call to action, it’s crucial that our members take the required action.

I urge all members to take a few minutes to oppose limitations on compounding by filling out a letter to the FDA prepared by the Academy.

take action

Dr. Desai is a clinical assistant professor of dermatology, University of Texas Southwestern Medical Center, Dallas, and in private practice. He is the incoming chair of the Academy’s Leadership Development Steering Committee, and a member of the Grassroots Advocacy Workgroup, Health Care Finance Committee, and SkinPAC. He is also the AAD representative to the AMA as an alternate delegate to the AMA HOD Dermatology Section Council. He is the president-elect of the Texas Dermatology Society, and Secretary/Treasurer of the Skin of Color Society.