Dec. 2, 2019 – In its sixth Untitled Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) cited Nascent Biotech Inc. for promoting an investigational new drug (IND) as a safe and effective treatment for brain cancer on its website. This is the second enforcement letter in 2019 to address issues related to the promotion of INDs.

“This appears to be a blatant violation of FDA guidelines on communication about investigational new drugs,” pointed out Jon Bigelow, executive director of the Coalition for Healthcare Communication, “and one that the OPDP clearly could not let stand without action.”

The Nascent website includes claims and presentations that promote the IND Pritumumab as safe and effective for the purposes for which it is being investigated, according to the Nov. 1 Untitled Letter, and includes the following statements:

• “Pritumumab has cured a rare form of brain cancer”
• “Delivering human antibodies for the treatment of cancer”
• “After 5 years, patients treated with pritumumab have an overall survival rate of 25- 30%, compared to 3% standard therapy, demonstrating antibodies are safe and effective”

Although INDs are exempt from adequate directions for use because they are not yet approved, this exemption stipulates that sponsors or investigators (or their agent) “shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.”

OPDP asserts that the website’s “numerous conclusory statements” that Pritumumab has been established as being safe and effective in treating brain cancer “are extremely concerning given the lack of adequate safety and efficacy data for Pritumumab.” The enforcement letter also states that “the suggestion that Pritumumab has established efficacy and has ‘cured a rare form of brain cancer’ is especially troubling given that brain cancer in general is a disease associated with a poor prognosis.”

OPDP also notes that the Nascent website “does not include information to clearly indicate that Pritumumab is an investigational new drug that has not been approved for distribution in the United States.”

Including the two enforcement letters issued for IND concerns, OPDP has issued six Untitled Letters and two Warning Letters thus far in 2019.