In only its second enforcement missive this year, the FDA's Office of Prescription Drug Promotion takes Pfizer to task over an Estring video. The direct-to-consumer promo "fails to include any risk information" about the hormonal therapy for postmenopausal women, the agency's untitled letter said.
The video depicts a doctor and a patient, both identified as spokespeople, talking about how Estring had worked for the patient, and at one point, the patient says she doesn't suffer any side effects. That’s a big no-no for OPDP. While one individual may not experience any side effects, the letter points out, it is misleading to suggest others using Estring could expect a similar result.
A Pfizer spokesman said the video arose from an awareness effort for National Women's Health Week in May. The company offered an OB-GYN and one of her patients for interviews to several media outlets, focusing on postmenopausal women's health. Estring is approved to treat moderate-to-severe symptoms of vulvar and vaginal atrophy due to menopause.
According to the OPDP letter, the video is “especially concerning from a public health perspective because it fails to include any risk information about Estring, which is a drug that bears a boxed warning due to several serious, life-threatening risks.” Estring's product information includes boxed warnings for endometrial cancer, cardiovascular disorders, breast cancer and dementia. Pfizer has until July 3 to respond to the complaint.
"Patient safety and the appropriate use of our medicines are of the utmost importance at Pfizer," the company said in a statement emailed to FiercePharma. "Pfizer recognizes the importance of appropriately communicating about medical conditions and the risks and benefits of our medications. We take this matter very seriously and remain committed to complying with all applicable laws and regulations."
So does the second letter of the year mean the glacial pace of OPDP enforcement could be picking up? That may be overly optimistic. While OPDP is ahead of its pace for 2017—with only one letter in the first half—it's still just two letters within six months. OPDP ended 2017 with five letters total, three of them in November or December.
The more notable bellwether of annual letter proliferation—or lack of it—may be the general decline in the number of letters sent over the past several years. In 2016, OPDP sent 11 letters to pharma companies for marketing violations, and in 2015 and 2014, it sent just nine and 10, respectively.
Why do letters even matter? Pharma marketers and their agencies often use the letters as indications of FDA boundaries that aren't clearly articulated in the agency's sometimes confusing and often nuanced rules around pharma promotions. Fewer letters mean less insight into the agency’s point of view.
Social media is a particularly problematic area where marketers have looked to letters for insight in the absence of long-awaited and still-pending guidelines. The agency last issued any formal guidelines for social media in 2014.