The average wait time for getting help from the iPLEDGE call center in December was 2 minutes, according to Covance spokesperson Laurene Isip.
“The program is definitely running light-years better” than it did at the start, said Dr. James Del Rosso, of the department of dermatology at University of Nevada, Reno, and immediate past chairman of the AAD's Environment and Drugs Committee.
Dr. Sharon Gardepe, who has a solo practice in general dermatology in Huntsville, Ala., called her legislators and the AAD soon after implementation about her concerns and experience with iPLEDGE. She also created a handout listing local legislators to give to her patients who complained about the program. “Giving them the list underlined the fact that it wasn't me,” she said.
One year into the program, Dr. Gardepe said her hour-long phone calls to Covance are a thing of the past, but the requirement that prescriptions be picked up within 7 days and the rule that lab tests be conducted no sooner than 1 day before the office visit still result in “a lot of time spent troubleshooting.
“Some people are optimistic that we might be better able to work with [FDA and Covance], but I'm still skeptical” about the extent of future change, she said.
Dr. Siegfried said such skepticism is understandable. “I really am optimistic. I do think that Dr. Walker [at the FDA] wants to build bridges,” she said. “But in the end it's not her call—it's Congress.”
Dr. Siegfried and other AAD leaders urge physicians to remain vigilant and active. Isotretinoin, they caution, will likely be in the limelight this year, since Rep. Bart Stupak (D-Mich.) has announced that he wants to hold a congressional hearing on the FDA's management of the drug.
Dr. Siegfried said that she believes the decision to collect a full year of baseline data and then another year of comparison data before reporting pregnancy rates—rather than releasing iPLEDGE data quarterly, as was first anticipated—reflects the realization that “if the data were made public [along the way], and there's been one pregnancy, it will haunt us and we won't have the drug [at all].”
Dr. Stone said he too is concerned, saying that iPLEDGE “will minimize the number of pregnancies by forcing people to go through the hoops, but I don't think we'll ever eliminate pregnancies.”
The iPLEDGE program 'is definitely running light-years better' than it did at the start. DR. DEL ROSSO