Company’s ‘Game-Changing’ Claim Needs More Game, FDA Says

Company’s ‘Game-Changing’ Claim Needs More Game, FDA Says | Regulatory Doctor

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By Alexander Gaffney, RF News Editor 

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The US Food and Drug Administration (FDA) has sent an untitled letter to ParaPRO, a start-up pharmaceutical company whose products focus on the treatment of head lice, saying the company’s “game-changing” product isn’t quite as good as it’s hyped up to be.

The company won approved for its Natroba (spinosad) Topical Suspension product in 2011, the “first FDA-approved prescription head lice treatment that does not require nit combing,” it said.

“Unlike many other currently available treatments, most children will only require one application and do not need to sit through extensive, time-consuming nit combing sessions when Natroba is used,” the company explained in its approval announcement. “This means that parents trying to rid their children of head lice will soon have an important new treatment option given the ease of use and effectiveness of Natroba.”

A Common Refrain Bordering on Hubris

That refrain has become a relatively common one for ParaPRO, which has used similar explanations in various marketing materials. But according to FDA, some of those materials have taken that claim too far, with hubris bordering on unsubstantiated claims.

“The FDA has approved what could be a game-changing medication in the war against head lice; one that doesn’t require nit combing to be effective,” the company says in a video news release (VNR) message sent to FDA. “It’s called Natroba.”

But it’s hardly “game-changing,” FDA said. “This claim misleadingly implies that Natroba represents a new or different approach in the treatment of head lice, one that is a significant advance over other currently available products, when this has not been demonstrated by substantial evidence or substantial clinical experience.”

But while the product doesn’t need nit combing to be effective, numerous other products also don’t require nit combing to be effective, making the “game” a rather crowded one. Without the company offering data showing superiority, it’s a game FDA assumes even odds for—and an unsupported claim.

But FDA goes further, saying that the company doesn’t quite communicate what it’s actually approved for in the video message. FDA said the advertisement “fails to convey that Natroba should be used in the context of an overall lice management program.” To borrow a metaphor, perhaps a bit like only describing how a team is undefeated, but neglecting to mention that record is only based on its last three games. [Emphasis added]

An Omission of Risk

The company was also chided by FDA for allegedly failing to mention any of the products risks in the ads—a huge violation of FDA’s “fair balance” advertising standards.

According to FDA, the video failed to mention any of ParaPRO’s associated risks, including precautions regarding benzyl alcohol toxicity, which is associated with “serious adverse reactions and death in neonates and low birth-weight infants.” Other common side effects include application site inflammation and ocular inflammation.

It should be noted that FDA regularly sends out untitled letters to companies for even minor omissions of risk information, and even images that might be construed to influence a patient’s risk perception, however implicit.

An October 2012 untitled letter to Endo Pharmaceuticals, for example, chided the company for having made mention of other side effects of the product, but instructing readers to obtain them elsewhere. Another October 2012 letter hit Genentech for the use of a mostly-horizontal hourglass, which FDA took to mean that the company was promoting its product as being able to stop the progression of metastatic non-small cell lung cancer (NSCLC). And a series of letters sent to Alcon since 2006 repeatedly cite the company for downplaying the risks associated with its products by omitting required risk information.

So it is perhaps notable that FDA, using boldfaced font, observes that ParaPRO “entirely omits all risk information, including the warning and precaution regarding benzyl alcohol toxicity and the most frequently reported adverse events from the Package Insert (PI).”

“By omitting the most serious and frequently occurring risks associated with the drug, the VNR misleadingly suggests that Natroba is safer than has been demonstrated.”

The company was requested to respond to the letter by 7 March 2013 and to cease marketing the product using the VNR “immediately.” [Emphasis added]

via Company’s ‘Game-Changing’ Claim Needs More Game, FDA Says.

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