FDA Warns Targeted Medical for Misbranding a Drug as Medical Food
The FDA issued Targeted Medical Pharma a warning letter for failing to submit an IND application prior to beginning clinical investigations for a product the agency deemed to be a drug.
The Los Angeles-based biotech firm had responded to a Form 483 in 2016 arguing its products were medical foods used to treat nutritional deficiencies associated with pain and inflammation. But the FDA said the product did not meet the Orphan Drug Act’s definition of “medical food,” because the condition it claims to treat is not associated with any distinctive nutritional requirements.
FDA officials had previously warned Targeted Medical Pharma that the company should apply for an IND ahead of any clinical trials, even if it did not plan to submit an NDA.
The company claimed to have reached out to FDA officials before the trials and to have filed an IND application, but the agency was unable to find any documentation confirming receipt.