FzioMed, a healthcare products manufacturer based in San Luis Obispo, California, filed a citizen’s petition with the United States Food and Drug Administration (FDA) in response to the regulatory agency’s rejection of the company’s Oxiplex spinal gel. The citizen’s petition requests that the FDA re-open the rejected premarket approval application for the spinal surgery gel.
The company first filed its PMA for the product in October of 2007. In July of 2008, the FDA sent FzioMed a rejection letter due to concerns about the product’s efficacy. The federal watchdog agency determined that the company had not provided adequate evidence of the gel’s efficacy.
Oxiplex surgical gel is designed to aid the body’s natural healing process following spinal surgery of the lower back. To date, the gel has been used in over 300,000 procedures. There have been no complications or adverse events related to the use of the product.
According to a press release, the gel is available in almost 70 countries. This includes countries in the European Union, Canada, Mexico, South Korea, Australia and Brazil. The U.S. is one of the only countries that rejected approval of the gel.
John Krelle is CEO and president at FzioMed. In prepared remarks, he stated, "Patients and spine surgeons across the United States are eager to take advantage of the safe, pain-relieving benefits of Oxiplex and hope the FDA will reconsider its decision to deny access to U.S. patients." He continued, "FzioMed strongly believes that there are several significant issues of scientific dispute that warrant review by an independent advisory committee."