FDA sues to halt production of 'unapproved' vaginal gel products

California contract manufacturer Laclede was warned. Now it is being legally stormed. After years of letters, inspections and meetings with the FDA couldn't move the company to seek an NDA for its vaginal gel products, the FDA has sued Laclede to get it to stop making them.

In a 16-page complaint filed by the U.S. Attorney's consumer protection branch, the FDA is seeking a permanent injunction against the Rancho Dominguez-based company and its president Michael Pellico. It wants Laclede to stop making and selling its Luvena Prebiotic products until it either gets an approved new drug application from the FDA or until it removes all of its drug claims from labels and marketing material. Those include that the products can be used to prevent or treat vaginal infections and that they can modulate vaginal microflora.

In a telephone interview Wednesday, Pellico said that the company has stopped production of the products and that it will be drop the use of what the FDA considers are drug claims. He said fight centered on the use of the word Prebiotic. "That is what they are most concerned with," Pellico said. "They say it is a drug claim. We disagree. But we don't have the resources to keep fighting this. We are a small company."

The lawsuit says that the FDA has sent letters to the company as far back as 2010, laying out the problems and explaining the steps it could take to seek approval of the products. It did inspections in 2011 and 2012, resulting in a warning letter. In addition to allegedly selling unapproved drugs, it said that Laclede was not testing APIs used in Luvena Prebiotic such as lactoferrin, lactoperoxidase, lysozyme, D-mannose, and glycogen before the drugs were released. The FDA rejected Laclede's contention that they were not APIs. Additionally, the warning letter said the contract manufacturer of private label and custom formulations was not testing for potency and stability, so it can't determine expiration dates. 

The lawsuit says FDA inspectors returned last year and found many of the same issues it had discussed with the company. Laclede requested that jurisdiction be moved to the device division, and when that was declined, asked for a meeting via the agency ombudsman. It said it was willing to file for a new drug application "after the meeting if necessary." At the meeting, the FDA held to its position. Several months later, it again notified Laclede it needed to meet FDA regulations. When nothing happened, it sought the injunction.

- read the FDA announcement
- here's the complaint (PDF)

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FDA slaps vaginal gel maker for sloppy manufacturing, no NDA