The Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Nascent Biotech Inc. regarding the company’s promotion of Pritumumab, an investigational new drug, on the company’s website, finding that the information on the website resulted in the drug being misbranded.
Pritumumab is an investigational new drug currently being studied by Nascent Biotech. The company’s website contains a series of claims and representations about Pritumumab, including that it i) delivers human antibodies for the treatment of cancer; ii) has cured a rare form of brain cancer; and iii) has an overall survival rate of 25%-30%, compared with 3% from standard therapy, demonstrating that antibodies are safe and effective (citing Phase II clinical trials conducted in Japan).
The OPDP found that Pritumumab is misbranded under section 502(f)(1) of the Food, Drug & Cosmetic Act (FD&C Act) because the claims on the website promote the safety and efficacy of an investigational new drug that has not been approved by the Food and Drug Administration (FDA).
The OPDP points to the fact that Pritumumab is an investigational drug with no marketing authorization in the United States. Given the promotional claims and representations being made about the drug, however, the OPDP finds that the drug is misbranded for the following reasons:
- Given its investigational status, the drug’s indications, warnings, precautions, adverse reactions, dosage and administration have not been established.
- There is a lack of safety and efficacy data available for Pritumumab.
- There are currently no adequate directions provided for the use of Pritumumab in the treatment of brain cancer.
Based upon the foregoing, the OPDP requests that Nascent immediately cease violating the FD&C Act.