Chen
Journey of the Modified Risk Tobacco Product (MRTP) Application Ii-Lun Chen, MD FDA Presentation to: TPSAC April 30, 2013 1
Disclaimer • The information in these materials is not a formal dissemination of information by FDA and does not represent Agency position or policy. The information is being provided to TPSAC to aid the committee in its evaluation of the issues and questions referred to the committee. 2
MRTPA Review Flow Chart & Tentative Timelines MRTP Application Receipt (Day 0)
Administrative Review (Day 14)
Internal Review & Discussions
Final Review & Action (Day 360)
Filing Action (Day 60)
3
Tentative Timelines for an MRTPA Review • • • • • • •
Premeeting with industry to discuss potential MRTPA Application Receipt (Day 0) Admin Review & Acknowledgement Letter (Day 14) Review Team Assignment (Day 14) Filing Action Letter (Day 60) TPSAC meeting Final Review and Action (360 days)
4
Application Receipt Process
MRTPA received by hand courier mail or electronic submission gateway
Application loaded into the CTP document repository
OS Regulatory Health Project Manager (RHPM) notified
5
Administrative Review
Yes Jurisdiction
No Jurisdiction
• Sends the Acknowledgement Letter to the applicant • Coordinates with other CTP offices • Assembles the review team
• Sends the Refuse to Accept Letter to the applicant
Review starts
Review ends
6
Filing Review Filing Review Completeness of the MRTPA
Filing Decision Letter issued within 60 Days
Filing Letter
Refuse to File Letter
7
Filing an MRTPA Section 911(d) of the TCA outlines requirements for filing an MRTPA. The statute explains that an application must include seven elements: (1) a description of the proposed product and any proposed advertising and labeling; (2) the conditions for using the product; (3) the formulation of the product; (4) sample product labels and labeling; (5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health; (6) data and information on how consumers actually use the tobacco product; (7) such other information as the Secretary may require. 8
Publicly Available • FDA reviews MRTP applications for completeness. Although some applications have been submitted, to date no application has been filed and none are currently pending before the agency for filing or substantive review. • When FDA does receive an application "described in subsection (d)," Section 911(e) states that “the Secretary shall make the application ... publicly available (with the exception of trade secret or commercial confidential information)." 9
Application Review Other Activities Public Availability • Docket opened • Disclosure of Application • Public comments collected
TPSAC • Review materials • Conduct Meeting • Provide Recommendations 10
Confidentiality Information submitted under section 911 of the FD&C act may include, but is not limited to, a company’s non-public, trade secret, or confidential commercial information. Several laws govern the confidentiality of tobacco product information submitted under section 911 of the FD&C act, including sections 301(j) and 906(c) of the FD&C act (21 U.S.C. 331(j) and 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of Information Act (FOIA) (5 U.S.C. 552) as well as FDA’s implementing regulations. FDA’s general regulations concerning the public availability of FDA records are contained in 21 CFR part 20. Section 911(e) of the FD&C act requires FDA to make an MRTPA publicly available except matters in the application, which are trade secrets or otherwise confidential, commercial information. See “Modified risk tobacco product applications DRAFT GUIDANCE, U.S. Department Of Health and Human Services Food and Drug Administration Center For Tobacco Products, March 2012.”
11
Applicant Submissions To facilitate FDA’s publication of the disclosable portions of an MRTPA under section 911(e) for public comment, FDA recommends that Applicants identify the portions of the application they believe constitute trade secret or confidential commercial information that is exempt from disclosure by either: • including in their cover letter a description or listing of such information • submitting two versions of the application – a complete, unredacted version and a second version with transparent highlights of the information believed to be exempt from disclosure. 12
Modified risk tobacco product applications DRAFT GUIDANCE, March 2012.
What is Publicly Available? FDA makes the final evaluation regarding what information can be made publicly available under section 911(e) of the FD&C Act. “The Food and Drug Administration will give consideration to all bases that have been stated in a timely manner by the submitter. If the Food and Drug Administration decides to disclose the records, the Food and Drug Administration will notify the submitter in writing. This notice will briefly explain why the agency did not sustain the submitter's objections. The Food and Drug Administration will include with the notice a copy of the records about which the submitter objected, as the agency proposes to disclose them. The notice will state that the Food and Drug Administration intends to disclose the records 5 working days after the submitter receives the notice unless a U.S. District Court orders the agency not to release them.” 21CFR 20.61. 13
CTP OS Review Members • • • • •
Office of Science Director or Designee Regulatory Health Project Manager Technical Project Lead Discipline Team Leader Discipline (Primary) Reviewer: Chemistry, Engineering, Toxicology, Addiction, Clinical, Epidemiology, Social Science, Statistics 14
Anticipated Review Activities • Individual disciplines discuss findings • Multi-disciplinary meetings held to discuss status of review and identify key issues • Preparations for TPSAC meeting • Communicate with the Applicant regarding concerns identified during the review and postmarket surveillance studies • Finalize Review and Recommendations 15
Postmarketing Surveillance Studies •
•
•
•
Applicants granted a risk modification order must submit protocols for required postmarket surveillance for FDA concurrence within 30 days after receiving notice that they are required to conduct such surveillance. Within 60 days of receipt of the protocol, FDA must determine whether the principal investigator is qualified to conduct such surveillance; and the protocol will result in collection of the data or other information FDA determines is necessary to protect the public health. Applicants granted an exposure modification order must also agree to conduct postmarket surveillance and studies in accordance with a protocol approved by FDA. In the draft MRTPA guidance, FDA recommends that these applicants follow the same timelines that apply to the approval of protocols relating to risk modification orders. All applicants must submit the results of postmarket surveillance and studies annually.
16
MRTPA Final Decision
Marketing Order Final Decision (Decision letter issued by Day 360) No Marketing Order 17
Disclaimer • The information in these materials is not a formal dissemination of information by FDA and does not represent Agency position or policy. The information is being provided to TPSAC to aid the committee in its evaluation of the issues and questions referred to the committee. 2
MRTPA Review Flow Chart & Tentative Timelines MRTP Application Receipt (Day 0)
Administrative Review (Day 14)
Internal Review & Discussions
Final Review & Action (Day 360)
Filing Action (Day 60)
3
Tentative Timelines for an MRTPA Review • • • • • • •
Premeeting with industry to discuss potential MRTPA Application Receipt (Day 0) Admin Review & Acknowledgement Letter (Day 14) Review Team Assignment (Day 14) Filing Action Letter (Day 60) TPSAC meeting Final Review and Action (360 days)
4
Application Receipt Process
MRTPA received by hand courier mail or electronic submission gateway
Application loaded into the CTP document repository
OS Regulatory Health Project Manager (RHPM) notified
5
Administrative Review
Yes Jurisdiction
No Jurisdiction
• Sends the Acknowledgement Letter to the applicant • Coordinates with other CTP offices • Assembles the review team
• Sends the Refuse to Accept Letter to the applicant
Review starts
Review ends
6
Filing Review Filing Review Completeness of the MRTPA
Filing Decision Letter issued within 60 Days
Filing Letter
Refuse to File Letter
7
Filing an MRTPA Section 911(d) of the TCA outlines requirements for filing an MRTPA. The statute explains that an application must include seven elements: (1) a description of the proposed product and any proposed advertising and labeling; (2) the conditions for using the product; (3) the formulation of the product; (4) sample product labels and labeling; (5) all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health; (6) data and information on how consumers actually use the tobacco product; (7) such other information as the Secretary may require. 8
Publicly Available • FDA reviews MRTP applications for completeness. Although some applications have been submitted, to date no application has been filed and none are currently pending before the agency for filing or substantive review. • When FDA does receive an application "described in subsection (d)," Section 911(e) states that “the Secretary shall make the application ... publicly available (with the exception of trade secret or commercial confidential information)." 9
Application Review Other Activities Public Availability • Docket opened • Disclosure of Application • Public comments collected
TPSAC • Review materials • Conduct Meeting • Provide Recommendations 10
Confidentiality Information submitted under section 911 of the FD&C act may include, but is not limited to, a company’s non-public, trade secret, or confidential commercial information. Several laws govern the confidentiality of tobacco product information submitted under section 911 of the FD&C act, including sections 301(j) and 906(c) of the FD&C act (21 U.S.C. 331(j) and 387f(c)), the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of Information Act (FOIA) (5 U.S.C. 552) as well as FDA’s implementing regulations. FDA’s general regulations concerning the public availability of FDA records are contained in 21 CFR part 20. Section 911(e) of the FD&C act requires FDA to make an MRTPA publicly available except matters in the application, which are trade secrets or otherwise confidential, commercial information. See “Modified risk tobacco product applications DRAFT GUIDANCE, U.S. Department Of Health and Human Services Food and Drug Administration Center For Tobacco Products, March 2012.”
11
Applicant Submissions To facilitate FDA’s publication of the disclosable portions of an MRTPA under section 911(e) for public comment, FDA recommends that Applicants identify the portions of the application they believe constitute trade secret or confidential commercial information that is exempt from disclosure by either: • including in their cover letter a description or listing of such information • submitting two versions of the application – a complete, unredacted version and a second version with transparent highlights of the information believed to be exempt from disclosure. 12
Modified risk tobacco product applications DRAFT GUIDANCE, March 2012.
What is Publicly Available? FDA makes the final evaluation regarding what information can be made publicly available under section 911(e) of the FD&C Act. “The Food and Drug Administration will give consideration to all bases that have been stated in a timely manner by the submitter. If the Food and Drug Administration decides to disclose the records, the Food and Drug Administration will notify the submitter in writing. This notice will briefly explain why the agency did not sustain the submitter's objections. The Food and Drug Administration will include with the notice a copy of the records about which the submitter objected, as the agency proposes to disclose them. The notice will state that the Food and Drug Administration intends to disclose the records 5 working days after the submitter receives the notice unless a U.S. District Court orders the agency not to release them.” 21CFR 20.61. 13
CTP OS Review Members • • • • •
Office of Science Director or Designee Regulatory Health Project Manager Technical Project Lead Discipline Team Leader Discipline (Primary) Reviewer: Chemistry, Engineering, Toxicology, Addiction, Clinical, Epidemiology, Social Science, Statistics 14
Anticipated Review Activities • Individual disciplines discuss findings • Multi-disciplinary meetings held to discuss status of review and identify key issues • Preparations for TPSAC meeting • Communicate with the Applicant regarding concerns identified during the review and postmarket surveillance studies • Finalize Review and Recommendations 15
Postmarketing Surveillance Studies •
•
•
•
Applicants granted a risk modification order must submit protocols for required postmarket surveillance for FDA concurrence within 30 days after receiving notice that they are required to conduct such surveillance. Within 60 days of receipt of the protocol, FDA must determine whether the principal investigator is qualified to conduct such surveillance; and the protocol will result in collection of the data or other information FDA determines is necessary to protect the public health. Applicants granted an exposure modification order must also agree to conduct postmarket surveillance and studies in accordance with a protocol approved by FDA. In the draft MRTPA guidance, FDA recommends that these applicants follow the same timelines that apply to the approval of protocols relating to risk modification orders. All applicants must submit the results of postmarket surveillance and studies annually.
16
MRTPA Final Decision
Marketing Order Final Decision (Decision letter issued by Day 360) No Marketing Order 17
