Buyer, beware

May 1, 2007

FDA Web page targets online buyers of isotretinoin; Effectiveness may be limited, AAD spokesman says; FDA working to address search glitches

Key Points

But one expert doubts the page will be completely effective, for reasons that include an early technical glitch for Web surfers, as well as the enduring allure of online pricing.

Early this year, the FDA launched a special Web page designed to pop up as a search result on Google and other search engines whenever a consumer types "isotretinoin" or any of its brand names (Accutane, Hoffman-LaRoche; Amnesteem, Genpharm; Claravis, Barr Laboratories; and Sotret, Ranbaxy Pharmaceuticals).

"It wouldn't surprise me" if the page has an impact, says Stephen P. Stone, M.D., chairman of the American Academy of Dermatology (AAD) ad hoc task force on isotretinoin and professor, department of dermatology, Southern Illinois University School of Medicine, Springfield, Ill.

"The people who are likely to shop on the Internet are knowledgeable enough that they will go through the search engines where it's likely to turn up," he tells Dermatology Times.

However, Dr. Stone notes, "Many people who do that kind of searching know that they shouldn't be buying it over the Internet anyway. So I'm not sure it's going to be 100 percent effective."

iPLEDGE didn't slow trend

"FDA believes that people are buying Accutane and its generic versions outside of the iPLEDGE distribution program because it is more convenient for some patients who don't want to make the time to go to a doctor, or who may not qualify for the program," says Crystal Rice, FDA spokeswoman.

Dr. Stone adds that, although he suspects circumventing iPLEDGE is the main motivator for online buyers, "Another factor might be the cost of the drug for patients whose insurance isn't covering it."

Either way, Ms. Rice says that, along with preventing pregnancy exposures, iPLEDGE was designed to prevent isotretinoin sales over the Internet.

"Unfortunately," she says, "many foreign and domestic sites offer Accutane and its generics online; they are easily accessible."

Tracking the size of this problem is perhaps impossible, though anecdotal evidence abounds, sources say.

"We are certainly aware that several Web sites, including sites based in foreign locations, offer the drug for sale. We do not have access to online sales data for these products," Ms. Rice says.

Dozens of sites found

Before iPLEDGE was created, AAD and the AAD Association performed an extensive online search to see how many sites were selling isotretinoin, Dr. Stone says.

"We found dozens of sites where one could order it online," which prompted a February 2004 AAD letter urging the FDA to crack down on Internet sales of the medication, he says.

If people can get isotretinoin without taking a pregnancy test and fulfilling other iPLEDGE criteria, Dr. Stone says, "It certainly increases the risk, both to the individual and to our ability to continue to prescribe the drug."

Although the task force doesn't know the exact volume of Internet sales, he adds, "The availability of this drug without going through iPLEDGE is as much or more of a concern" than it was under the previous yellow-sticker system.