Claims of Strength too Weak to Pass FDA Scrutiny as Merz Pharma Receives Untitled Letter

Another week has brought yet another advertisement that the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) says fails the regulatory tests of "fair balance" and substantiated claims.

Background

OPDP-formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC)-regularly sends out what are known as "Untitled Letters," which serve as admonishments to companies to cease using certain marketing materials, but fall short of the severity of formal Warning Letters and usually do not indicate that enforcement actions will be forthcoming.

So far this year, OPDP has sent 12 Untitled Letters (and one Warning Letter) to companies for allegedly violative promotional activities. And by and large those activities have all related to four classes of violations:

• overstating the benefits of a product
• understating or not stating the risks associated with the product
• makes misleading or unsubstantiated claims
• not presenting the risks of a product in fair balance with its benefits

And for Merz Pharmaceuticals, the recipient of the latest of those 12 untitled letters, the violations it is alleged by OPDP to have committed manage to meet three out of four of the above stated classes.

The Untitled Letter

The OPDP Untitled Letter, dated 31 July 2013, was sent in reference to a website Merz maintains for Naftin Cream 2% (naftifine HCl), an antifungal product intended to treat common fungal infections such as athlete's foot (tinea pedis).

The problem, OPDP writes in its letter to Merz, is that the website is "misleading" because it minimizes or omits risk information, overstates the efficacy of the drug, contains misleading claims about the drug, and includes unsubstantiated claims.

For example, with respect to efficacy, the website makes claims such as "Twice as strong, half as long" and "once a day for two weeks" in the banner of the website. FDA notes that the prominent banners do not, however, include any risk information-a violation of the agency's long-established "fair balance" interpretation of the FD&C Act.

FDA also took issue with the company's claim that the product, a version of which containing the same active ingredient was first approved in 1988, had a "proven safety [record]" of more than 20 years.  Since Naftin's cream formulation was only approved in 2012, and includes a different strength and dosage regimen, FDA said it disputed that the safety had been demonstrated for as long as contended, and said the claim overstated the safety of the product.

Other claims, such as the drug purportedly being eight times as successful at treating tinea cruris as other treatments through four weeks of treatment, and twice as effective through week six, were "misleading" because they were "not supported by substantial evidence," FDA wrote. The studies cited by Merz had only looked at the primary endpoint, and not intermediate ones such as success at various weeks of treatment. Similar claims regarding efficacy, such as the "twice as strong half as long" statement, were also unsupported by evidence, charged FDA.

In addition, FDA cited an allegedly misleading claim that "more than 90% of patients were able to adhere to the full course of treatment." Regulators said this claim was unsupported as well, noting that the cited study was not intended to study treatment adherence, and was unqualified to generate the cited conclusion of 90% adherence.

The alleged violations have the ultimate effect of making the product misbranded in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act), OPDP said, and the letter requests that Merz "immediately cease the dissemination of violative promotional materials for Naftin Cream … such as those described above."

As of the time of this article's publication, the company's website still contained the material cited by OPDP.

Untitled Letter to Merz

Copy of the Violative Material