FDA to AAD: Patients with severe illness can bypass 30-day wait for isotretinoin

On Feb. 1, 2016, Academy President Mark Lebwohl, MD, along with members of the American Academy of Dermatology Association (AADA) staff met with the FDA in Washington, D.C. to discuss the iPLEDGE program and tanning regulations. Member to Member recently discussed the meeting with Dr. Lebwohl.

Member to Member: What was the focus of your discussion related to the iPLEDGE program?

lebwohl-mark.jpgDr. Lebwohl: We stressed that the AAD strongly supports patient safety and an iPLEDGE program that protects young women from pregnancy while on the drug. However, we also strongly believe that iPLEDGE should reassess the unintended consequences the program has had on patients’ access to isotretinoin when use of the drug is urgent.

I presented the example of a 28-year-old female patient with pustular psoriasis, whose psoriasis cleared within a  couple of days on isotretinoin prior to the iPLEDGE program. Today, because she is of childbearing age, she would have to wait a month because of the iPLEDGE program before starting the drug even though she has a life-threatening condition..

Member to Member: What was the FDA’s response to your request for faster access for patients with severe conditions?

Dr. Lebwohl: They explained something that we didn’t know—something that most dermatologists don’t know. The iPLEDGE program offers an exemption request process for patients with serious medical conditions. This allows patients with severe conditions to bypass the 30-day waiting period and start isotretinoin in less than a day. As long as a female patient is absolutely certain she is not pregnant, she can bypass the pregnancy test and waiting period and start treatment.

This is, of course, a very important exemption and we told the FDA staff that we’d get the message to our members.

Member to Member: Did you discuss other issues related to iPLEDGE?

Dr. Lebwohl: One of the problems with the program is that patients have only seven days to purchase the isotretinoin and begin treatment after seeing their doctor. If they miss that narrow window, they have to wait another 30-days and repeat bloodwork. Imagine if that small window was open during the recent blizzard in Washington? If you couldn’t get out of your house to pick up your prescription, you’d have to start from scratch.

The FDA staff responded with a great willingness to consider the burdens of the program on physicians and patients. They promised to investigate the issues related to the program and offer solutions. They want this to be a good program that benefits everyone.

Member to Member: The Academy recently launched a campaign to encourage members and the public to write letters in support of the FDA’s proposed age-restrictions on indoor tanning. Did you discuss the Academy’s efforts at the meeting?

Dr. Lebwohl: We stressed that the Academy strongly supports the FDA’s proposed regulation and will do whatever it can to ensure it is published in final form as soon as possible.

The AADA staff and I were very pleased with the meeting. The FDA staff is supportive and understanding of our issues and seem eager to work with us to strengthen our relationship. 

A highlight of the upcoming Academy Annual Meeting will be an educational session with members of the FDA: “FDA Hot Topics:  The Evolving Regulatory Landscape,” which will be on Monday, March 7 from 1 – 3 p.m.  (If you can’t attend the session, it will be available for purchase in the AAD Store about 2-3 weeks following the meeting.)