On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
OPDP Issues Another Enforcement Letter Aimed at Preapproval Promotion
In the CBA Research letter, FDA clarifies that the scientific exchange exception to the prohibition on pre-approval promotion does not apply to claims of safety or effectiveness for an investigational use. OPDP cited several examples from CBT-1’s website, including:
- “ADMINISTERED ORALLY Oral delivery of CBT-1® prior to and during the administration of chemotherapy, achieves the required therapeutic concentration necessary to reverse multidrug resistance in the clinical setting.”
- “NO SIGNIFICANT OR LASTING TOXIC SIDE EFFECTS CBT-1® demonstrated no significant or lasting side effects in the clinical setting, and had a very favorable adverse event profile.”
- “MULTIPLE CANCERS Eight Phase I and II clinical trials, with patients that had failed conventional chemotherapy treatments, showed efficacy of CBT-1® in multiple cancers. Likewise, the targeted mechanism of action multidrug resistance of CBT-1® is found in the vast majority of all late stage human cancer types.”
The website also contained a downloadable presentation about CBT-1® clinical trials, which contained claims such as:
- “CBT-1® A Novel Multidrug Resistant Modulator for Cancer Chemotherapy”
- “CBT-1® Safety and Efficacy Profile
- Preclinical and Clinical research has consistently demonstrated the potential for CBT-1® to be safe and effective.
- The drug is safe, well tolerated, lacks harmful pharmacokinetic interactions when combined with chemotherapeutic agents . . . has produced clinically objective responses in heavily pretreated and/or late cancers.
- “ADVANTAGES OF CBT-1®”
- Reverses drug resistance in multiple cancer types.
- Strong safety and tolerability profile: side effects are manageable and non-life threatening.
- In advanced relapse cancers clinical trials demonstrate a meaningful response rate.
- Oral administration prior to chemotherapy achieves required concentration to reverse drug resistance
- Does not alter the pharmacokinetic profile of Doxorubicin and Paclitaxel (two MDR substrates).”
OPDP reminded the company that as an investigational new drug, the product’s indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. OPDP noted that although one of the slides stated that research has consistently demonstrated the potential for CBT-1 to be safe and effective, the slide was immediately followed by conclusive language regarding safety and efficacy. Also, while minimal disclaimers stated that an NDA has been submitted and is currently under review, such disclaimers were not sufficient to mitigate overwhelmingly misleading impressions on the website.