Aug. 30, 2018 – In its fourth enforcement letter of 2018, the FDA’s Office of Prescription Drug Promotion (OPDP) cited ASCEND Therapeutics US LLC for allegedly false claims in a sell sheet for EstroGel® 0.06%, stating that the sell sheet “is concerning because it falsely suggests that EstroGel contains the lowest effective dose of estrogen compared to other estrogen products.”

“While the number of letters is low this year, yet another letter citing long-standing policy demonstrates that OPDP is open for business,” said Coalition for Healthcare Communication Executive Director John Kamp. “Ignore the rules at your peril.”

Specifically, OPDP stated in the Aug. 16 Untitled Letter (https://bit.ly/2wvkJC9) that the sell sheet for EstroGel, which is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) and moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause, includes the following efficacy claims about the product:

• “Provides the lowest, effective dose of transdermal estrogen therapy to help meet your patients’ treatment goals”
• “In the 2017 North American Menopause Society (NAMS) Position Statement, NAMS recommends first-line treatment of VMS with the most appropriate, often lowest effective dose, of estrogen therapy consistent with treatment goals”
• “The dose of estradiol in EstroGel has been proven to be the lowest effective dose for the treatment of symptomatic postmenopausal women”

These claims, in the context of this sell sheet, “are false or misleading because they suggest that EstroGel provides the lowest effective dose of estrogen for the treatment of moderate to severe VMS due to menopause and moderate to severe VVA due to menopause compared to other estrogen therapies, including transdermal estrogen therapies, when this is not the case,” the letter states.

The sell sheet cites an article to support its claims, but OPDP asserts that the studies referenced in the article “are not sufficient to support claims suggesting that the dose of estradiol in EstroGel has been proven to be the lowest effective dose of estrogen for the treatment of symptomatic postmenopausal women.”

“Most of the recent enforcement letters from OPDP have focused on a lack of or misleading information.  This letter focuses exclusively on an efficacy claim,” according to Wayne Pines, Senior Director for APCO Worldwide. “OPDP has issued few enforcement letters this year.  It will be interesting to see whether, as the year ends, they seek to bring the total for the year to a much higher number,” Pines said.

Last year, OPDP issued a total of five letters, and had issued only two letters by this point last year. All four of this year’s letters have been Untitled Letters; last year OPDP issued three Warning Letters and two Untitled Letters.