Federal health regulators are warning Georgia based MiMedx that it has violated regulatory laws by selling injections containing human placenta.
The FDA letter outlines MiMedx violations of federal law, including failure to properly license a new drug application prior to marketing.
The products sold by the company contain human tissue, which requires a valid biologics license. The “untitled letter” issued by the FDA late last month is a first contact letter citing violations that may not be of regulatory significance for an official “warning letter.”
MiMedx Group Inc. sells amnion/chorion injectable products under the names AmnioFix and EpiFix. These products contain tissue from human amniotic membrane. Human placenta is thought to have great healing and restorative properties.
The company is registered to receive human placenta donations. As such, they accept the donations from scheduled cesarean section births and turn the tissue into an injectable product. The injections are marketed by the company for wound care, spine repair, to treat inflammation, scar tissue formation and generally to promote healing.
The injections are not FDA approved. In fact, the FDA says there are no licensed products which contain placental tissue.
FDA, MiMedx Disagree on Clinical Trial Requirements
In addition, tissue based products must be minimally manipulated to avoid the requirement for clinical trials. A requirement to which the company has not adhered. The FDA called on MiMedx to demonstrate the safety and efficacy of the products through clinical trials.
MiMedx has indicated that the problem exists in how the company grinds their product, a process known as micronization. The process is what the FDA says puts the injectables in a category of manipulated tissue, thus categorizing the tissue as a drug and requiring FDA approval and licensing.
According MiMedx, the injectables fall under Section 361 of the Public Health Service Act, and are not subject to FDA approval requirements. MiMedx contends that because the product contains human tissue, testing is unnecessary since the tissues are already at work in the human body.
The company also cited a recent FDA inspection of the MiMedx facility, stating they received a “NAI notice,” No Action Indicated, dated December 2012. MiMedx has shipped 18,000 vials of AmnioFix and EpiFix over the last two years.
In response to the issues, MiMedx investors filed a class-action lawsuit against the company alleging that false and misleading claims have been made about the products. According to the allegations, MiMedx made false statements about whether AmnioFix required FDA approval to be manufactured and marketed. In addition, the company allegedly falsely inflated stock market prices.
MiMedx could face serious FDA action if the company fails to properly address the violations and adhere to FDA requirements. The company may be subject to receiving an official “warning letter,” and if that does not get an appropriate response, actions against the company could include legal action, seizure, injunction, and withholding approval of requests for approval of new products.