The FDA sent in the men with the badges and the guns to Crescendo Therapeutics this week after the Vista, CA, company ignored an earlier warning about selling an unapproved prescription skin cream.
The FDA says in a release that U.S. marshals confiscated Crescendo's HybriSil product, a topical corticosteroid cream that the Southern California company claims will help remove scars. The FDA inspected the company and the product a year ago and followed up in November with a warning letter saying the cream was not FDA approved. It also says HybriSil "fails to carry adequate directions for use." The letter points out that the company had no procedures for evaluating and notifying the FDA about reports of adverse reactions. The FDA was unimpressed when Crescendo management told inspectors that they had not received any complaints "so far."
In January, the company submitted an investigational new drug application for HybriSil that proposed limited distribution for investigational use, but in a follow-up visit that month, FDA says it found that the company was still distributing it more broadly. Crescendo President Eric Glader tells Pharmalot there had been discussions with the FDA and Crescendo had requested another meeting. Instead of a reply, he said it got a visit from marshals.
Sarah Clark-Lynn with the FDA in an email to FiercePharmaManufacturing says Crescendo distributes the product but that it is manufactured by another company that has been inspected by the FDA within the last 18 months.
The FDA says there have been no reports of adverse reactions from using Crescendo's product but says it needs to take a hard line against unapproved products to protect consumer safety. The potential dangers in even approved medications were showcased last month when the agency had marshals confiscate from Pharmaceutical Innovations in New Jersey ultrasound gel that has been tied to infections of babies in neonatal units.