On May 24, FDA issued guidance for industry and investigators, Meetings with Industry and Investigators on the Research and Development of Tobacco Products, which aims to assist tobacco manufacturers, importers, researchers and investigators who would like to meet with the staff of FDA’s Center for Tobacco Products (“CTP”) to discuss their research and development plans related to tobacco products. The FDA Guidance is intended to help researchers and developers address issues related to their tobacco products before they file tobacco products submissions with CTP. For example, the FDA Guidance suggests that researchers/developers could request a meeting with FDA/CTP “to discuss the appropriate design of post-marketing studies during the review of a pending modified risk tobacco product application.”
The FDA Guidance is not substantive, but rather procedural, to create a streamlined process for tobacco companies to seek input from FDA/CTP prior to filing a tobacco product submission. FDA advises that tobacco companies and/or developers should submit a meeting request containing basic product information and a proposed agenda, including, for example, the product’s name, category (e.g., cigarettes, smokeless tobacco), potential use (e.g., for consumer use or further manufacturing), the company’s contact information, and the type of meeting being requested (e.g. tobacco product application, such as a premarket tobacco application, or research regarding the development of a tobacco product). Additionally, the meeting request should include information outlining: (i) the purpose of the meeting; (ii) specific objectives/outcomes expected from the meeting; (iii) estimated times for each agenda item and who will speak; (iv) specific questions for FDA/CTP; (v) the meeting’s attendees; (vi) and the date on which the company will submit the required information package (as discussed below); and (vii) the suggested format of the meeting (e.g., conference call, in-person). FDA states that it will respond to a company’s request for a meeting within 21 calendar days of receiving the request and meetings will be scheduled for 1 to 1.5 hours.
As noted above, prior to meeting with FDA/CTP, requestors should submit an information package, which, in addition to the items outlined above, should include the following information related to research that has already been conducted on the tobacco product:
- Chemistry, manufacturing, and control data summary;
- Preclinical data summary;
- Clinical data summary;
- Behavioral and product use data summary;
- User and non-user perception data summary; and
- Investigational plans for studies and surveillance of the tobacco product, including:
- Study objectives;
- Study hypotheses;
- Study designs;
- Study population (inclusion/exclusion criteria, comparison groups);
- Human subject protection information (including IRB information);
- Primary and secondary endpoints;
- Sample size calculation;
- Data collection procedures;
- Duration of follow-up and baseline and follow-up assessments; and
- Data analysis plans.
The information package should be submitted to FDA/CTP at least 45 days prior to the scheduled meeting date. FDA also states that meetings should be limited to the information contained in a company’s information package; however, the information contained within the initial package can be updated with any new developments that occur after the package’s initial submission and before the meeting. After the meeting, FDA staff will provide attendees with official minutes of the meeting that summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion, and action items. FDA will distribute the minutes within 45 days after the meeting takes place.
Importantly, tobacco companies should be aware that their information packages may include information that is non-public or confidential, or constitutes trade secrets. In regard to this issue, the FDA Guidance states that it will abide by federal laws governing confidentiality, including such provisions within the Federal Food, Drug and Cosmetic Act, the Trade Secrets Act, and the Freedom of Information Act. It would be wise, however, to consult legal counsel during the entire meeting request process, especially prior to submitting an information package that might contain confidential information or trade secrets.