FDA Denial Of Thumbsucking Deterrent's Efficacy "Myopic" - Oakhurst

FDA's denial of a citizen petition requesting cayenne pepper be recognized as a safe and effective deterrent against thumbsucking and nailbiting is arbitrary and capricious, Oakhurst says in April 2 comments.

Oakhurst, which markets the cayenne pepper-containing product Thum, contends that, in denying the petition and refusing to include cayenne pepper in a final monograph for thumbsucking and nailbiting deterrent drugs, FDA did not allow Oakhurst to submit information that would have supported its position.

In September 1993, the agency published a final rule stating any product marketed as a deterrent to thumbsucking or nailbiting could not be recognized as safe and effective and, therefore, would be regarded as an unapproved new drug.

Levittown, N.Y.-based Oakhurst filed a citizen petition in February 1995, beginning almost six years of correspondence culminating in a Dec. 11 letter denying the petition.

Oakhurst counsel Gary Yingling (McKenna & Cuneo, Washington, D.C.) maintains the denial was particularly unfair because, after receiving a letter from Division of OTC Drug Products Director Charles Ganley, MD, on May 16, 2000 stating more data were needed to support the safety and efficacy of cayenne pepper, "Oakhurst gave the FDA written notice on several occasions that it intended to file additional comments."

Those comments make up the April 2 submission, which was filed in the hope FDA would reconsider its Dec. 11 decision. In a separate attempt to resolve the disagreement, Yingling also submitted a letter Feb. 2 to Center for Drug Evaluation & Research Ombudsman James Morrison.

Included in the April 2 submission is an as-yet unpublished study conducted by Patrick Friman, PhD, University of Nevada, Reno.

Retained by Oakhurst as a childhood behavior expert, Friman notes aversive taste treatment (ATT) products "may be the most effective thumbsucking treatment available to parents....It is my opinion that any bitter substance, including denatonium benzoate or cayenne pepper, can serve as an effective ATT product."

The 36-child study, which is being submitted to the journal Pediatrics, is one of several trials that prove "'aversive taste treatment' is effective in helping to break the thumbsucking habit," the comments state.

The study was conducted using Purepac Pharmaceutical's Stopzit and measured the "percentage of intervals" during which parents observed thumbsucking.

Parents were instructed to observe their children five times during a two-hour period and record incidences of finger sucking. Children given ATT therapy reduced the number of times they sucked their fingers by an average of 3.51 times while the controls showed only a .29 reduction.

FDA originally concluded Oakhurst's data were insufficient because the studies did not all look specifically at cayenne pepper; the new trial does not study the ingredient either, as Stopzit contains denatonium benzoate.

However, Oakhurst's comments state FDA "misunderstood the purpose behind the inclusion of these studies," which "demonstrate the effectiveness of aversive taste products generally...any bitter substance could be used for aversive taste treatment."

The memo also asserts that the agency's insistence on medical data is absurd. "FDA has become so myopic" in its calls for double-blind clinical trials "that it cannot see the obvious - namely, that cayenne pepper helps kids stop sucking their thumbs because it tastes bad."

If the agency decides against including cayenne pepper in a thumbsucking/nailbiting deterrent drugs monograph, it could still classify Thum as an "old drug," the comments state.

The memo notes the original petition "provided detailed evidence that Thum was a pre-1938 'old-drug' and therefore outside the administrative OTC review." Moreover, "Oakhurst submitted documentation proving that the product formulation has not changed since 1935 as well as product labels from 1948 and 1952."

Finally, the comments note Thum could even be considered a cosmetic - placing it outside the OTC review - since it does not treat a disease, but rather simply helps someone change their appearance.

Oakhurst also filed an entirely new citizen petition, encompassing the April 2 comments and additional data, in case the agency does not reconsider the original petition and Oakhurst has to "start this whole five-year process over again."