FDA Seizes Products at Crescendo Therapeutics
May 23rd, 2012 // 12:32 pm @ jmpickett
For months, Crescendo Therapeutics appears to have been thumbing its corporate nose at the FDA. Last November, the agency warned the little company for failing to maintain a system for collecting adverse event reports for its HybriSil topical treatment for scars. Crescendo offered a novel explanation – side effect reports simply had not been received (back story). Moreover, the FDA upbraided Crescendo for marketing HybriSil in the first place – the product, you see, was never approved.
This past January, however, Crescendo attempted to make amends and submitted an Investigational New Drug Application that permitted limited distribution – specifically, for investigational use only. But after another FDA inspection, the agency noted that HybrSil was still being distributed for other purposes. The product web site, for instance, continued to solicit physicians to stock the treatment, which is a corticosteroid (the site was taken down last night). Meanwhile, the labeling failed to carry adequate directions for use.
And so, the FDA this week had the US Marshals visit Cresendo facilites in Vista, California, and seize its supplies of HybriSil (read here). The move comes as the agency continues working hard at displaying a get-touch approach toward manufacturers that allegedly jeopardize safety or undermine the integrity of the supply chain, issues that have overshadowed agency activities for the past few years in the wake of the Vioxx and Heparin scandals.
For its part, Crescendo maintains efforts were made to work with the agency. Crescendo president Eric Glader tells us talks were held in response to the November warning letter. “We had the right to have a dialogue about the issues they raised and we were doing so,†he says. “…We had requested another meeting, but we didn’t hear from them. Instead, they sent us a letter this month to discontinue the product and the next day, Marshals showed up at our offices. But if that letter had come two or three months earlier, we would have removed product (from the market) then.â€
He adds, however, that Crescendo plans to follow through on its submission and return HybriSil to the market. Of course, some might say such an outcome was predictable, if only because the FDA made clear months earlier that HybriSil was considered misbranded and ongoing sales was problematic. In effect, ignoring FDA entreaties is tantamount to an invitation to an enforcement action. In any event, Crescendo promoted HybriSil with a slogan that promises that one can ‘Kiss Your Scars Goodbye.’ Now, the aspiring drugmaker can kiss its revenue goodbye.
