Using an online service to design your own mugs and tee-shirts may seem like a fun idea but applying the program to a drug promotional piece can be risky.

A sales rep for Ascend Therapeutics US LLC appears to have used Zazzle to make a card promoting cost savings with its EstroGel (estradiol gel). The piece drew a citation from FDA’s Office of Prescription Drug Promotion for its omission of serious risks associated with the drug.

In a June 23 untitled letter, posted on the agency’s website July 10, OPDP said the omission misleadingly suggests that the drug is safer than has been demonstrated.

The déclassé card stands out for its low production values. The cover consists of the phrase “I ♥ to Pay More.” The second page adds: “. . .said no one EVER!” It then notes that the company’s patient savings program can be used by insured customers, “cash pay (Medicare patients),” mail order pharmacies and mail in reimbursement.

Below this is the statement: “In clinical studies, the most commonly reported adverse events for EstroGel were breast pain, headache, and flatulence.”

The final page has the company name and a “Zazzle” logo. Zazzle provides a service for people to custom design their own postcards, invitations and other products. The company makes the products and mails them to the customer.

"Home brew" promotional materials have always been a tricky issue for firms who want to ensure compliance but also encourage creativity from their field forces. The proliferation of relatively inexpensive design and printing services on the Internet can make it more tempting for a sales rep to go off script.

FDA's letter didn't specify, and Ascend didn't respond to questions about, whether the EstroGel cards were made by a lone sales rep, but the overall appearance and third-party branding suggests they were not a mass corporate production.

Boxed Warning Information Is Missing

OPDP said the card fails to include important risk information, including the boxed warning that the drug should not be used alone, or with progestin, for the prevention of cardiovascular disease or dementia. It also “fails to disclose material information about the specific risks related to cancers and cardiovascular disorders discussed in the Boxed Warning section” of the product labeling, “which includes endometrial cancer, invasive breast cancer, deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction,” OPDP stated.

“Furthermore, the Zazzle card fails to include any conditions for which EstroGel is contraindicated,” the letter says. OPDP stated that while the card directs people to a website for additional information and to “see enclosed full prescribing information and a boxed warning,” this “does not mitigate the omission of these important risks.”

FDA requested that Ascend cease these violations and submit a written response by July 8.

‘Clunky’ Online Tools Make Zazzle Difficult To Use

While Ascend could have avoided FDA’s rebuke by including the missing risk information it may have been hampered by the Zazzle program. PC Magazine noted in an online review that the service can be difficult for novices to navigate.

“Zazzle gives users a lot of control over the elements being customized – design, images, text – letting would-be designers alter the place, size, and layering of elements, but the app’s online tools aren’t as rich as a full image editing program,” the review states. “On the other hand, they’re slightly too complex for anyone who isn’t quite as tech-savvy with image editing.”

The reviewer added that “Zazzle’s online tools were so clunky” that she wasn’t in any rush to make another custom product.

A specialty pharma firm based in Herndon, Va., Ascend is a subsidiary of the Bangok, Thailand pharmaceutical company Besins Healthcare SA. Ascend is focused solely on women’s healthcare. EstroGel is the only product listed on the company’s website.

Ascend got its jumpstart by in-licensing drug candidates from Besins International Holdings, which specializes in the manufacture of hydroalcoholic pharmaceutical gels that are quickly absorbed into the skin. Besins licensed rights to develop and market AndroGel (testosterone gel) to Solvay Pharmaceuticals Inc. Also see "Ascend Therapeutics Inc." - Scrip, 1 February, 2004..

Ascend is the seventh company to receive a letter from OPDP this year. Most recently, Actavis received an untitled letter in May for a webpage suggesting its benign prostatic hyperplasia drug Rapaflo (silodosin) improves sleep quality and work productivity ([A#14150521002]).

Don't Try This At Home: Zazzle-Created EstroGel Promo Card Fizzles With FDA

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