U.S. judge rejects FDA bid

Source Reference

A federal court judge in LA has ruled against the FDA. Judge Bernal ruled against the FDA’s motion for summary judgment. The FDA had sued California Stem Cell Treatment Center, their founders, and others. Bernal indicated it was suitable for trial. The FDA accused these groups of using unapproved drugs to treat patients. However, the defendants refuted the allegations because in fact the biological substance comes from the patients themselves and not an outside source.

The government filed a case on May 9, 2018 against Florida-based U.S. Stem Cell Clinic the same day as the case in California. In contrast Judge Ungaro in Miami ruled against the Florida clinic, the 2 cases are not linked and the outcomes are separate.

The U.S. Supreme Court made a decision last June, 3 weeks after Judge Ungaro’s ruling in Miami in the case titled Kisor v. Wilkie. The implication is that the courts would defer to the agency as per the circumstances.

Bernal made a reference to the U.S. Supreme Court ruling in Kisor v. Wilkie. The judge indicated that the FDA’s assertion that stem cell preparations are illicit drugs “is not entitled to deference.” By contrast, Judge Ungaro decided the opposite by stating that the agency’s version “must be given deference.”

The FDA did not comment on Bernal’s decision because the case is still “pending litigation.” It is plausible to some practitioners and advocates that the FDA is outside of their jurisdiction regarding a surgical procedure.

The California defendants elucidated that their procedures should be an exemption from FDA oversight because cells and tissues are extracted from a patient and then reinjected into the patient during the “same surgical procedure.”

0 0 votes