FDA Requirements 5/16/2011. FDA and new IND regs. Changes on the horizon: CIOMS IX ICH upcoming initiatives

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1 Session Overview (1) Although the role of the Qualified Person responsible for Pharmacovigilance is mandated by the European legislation, the QPPV is held responsible for the establishment and the maintenance of the pharmacovigilance system which oftentimes means the global PV system. Therefore, it is important that the QPPV plays an active role in identifying non-eu requirements which may have an impact on the global PV system to ensure continued compliance with global regulations. In addition, QPPVs should be involved in the thought-shaping initiatives such as CIOMS and ICH. This session will highlight some of the new and upcoming non-eu regulations and initiatives that will influence PV in the future. Drug Information Association 1 Session Overview (2) FDA and new IND regs Peter De Veene, Roche, Deputy EU QPPV Changes on the horizon: CIOMS IX ICH upcoming initiatives Valerie Simmons, Lilly QPPV, Global Patient Safety, Eli Lilly and Company Ltd., UK Impact of Japanese PV Environment on QPPV Activity Yoshiaki Ohashi, Ph.D. Global Pharmacovigilance Head, Pharmacovigilance Manager, Chugai Pharmaceutical Co., Ltd Drug Information Association 2 FDA Requirements Impact on the global PV system Dr Peter De Veene Deputy EU QPPV Roche 1

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 4 Outline Safety Reporting Requirements for INDs and BA/BE Studies Published Sep 2010 Dear Health Care Provider Letters: Improving Communication of Important Safety Information Published November 2010 Post Marketing Studies and Clinical Trials Published April 2011 Drug Information Association 5 Background FDA Intent for Regulation Changes Harmonize with international standards Enable fewer but more complete and meaningful individual reports for FDA and investigators Specific protocol guidance Identifying the sponsor as having more overt responsibility for aggregation and analysis of events Expedite FDA s review of critical safety information Anticipated benefits Better data to support clinical decision making Better protection of human subjects New FDA IND Reporting regulations (21 CFR ) and Bioavailability and Bioequivalence regulations (21 CFR ) Published in Sept 2010, effective 28 March /25/11: FDA notice of enforcement discretion with expectation of full compliance by 9/28/11 2

3 Key Changes and Clarifications Definitions Harmonize with international standards New expedited safety reporting requirements Other Findings (e.g., epidemiologic data, pooled analysis, pre-clinical data) Report if findings suggest a significant human risk Any clinically important increase must be reported in the rate of a serious suspected adverse reaction over that listed in the protocol or IB Study Endpoints, Disease-related events, etc Report per the protocol (not as an individual SUSAR) unless there is evidence suggesting a causal relationship with the drug All SAEs in IND exempt BA/BE studies conducted in the US Unblinding expected Life-Threatening and Seriousness assessments Sponsor OR Investigator Opinion Causality assessments Sponsor determines causality Dual Reporting (IND / NDA) Drug marketed or approved (1) in the US? Under US IND? Trials site Must report to IND? yes yes US or foreign yes yes Must report per postmarketing requirements? yes No US or foreign No yes No yes US or foreign yes No No Foreign (1) If a drug is approved in the US, but is not currently being marketed in the US, the postmarketing requirements would still apply 8 Definitions AE: Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Suspected adverse reaction (SAR): Any adverse event for which there is a reasonable possibility that the drug caused the adverse event. Definitions Associated with Aggregate Data Reviews FDA Expectation Expedited reporting for findings from clinical studies, epidemiological studies or pooled analyses of multiple studies that suggest a significant risk in humans exposed to the drug. Pre-clinical finding suggests a significant risk in humans. Expedited reporting for any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or IB FDA Comment Qualification for reporting based on outcome of the finding (i.e., safetyrelated change in the protocol, IC, IB, or other aspects of the overall conduct of the clinical investigation) FDA Day 0 Comment The day that the sponsor determines that a finding suggests a significant risk in humans 3

4 Causality Assessment Investigator provides a causality assessment but the sponsor determines whether the event meets expedited reporting criteria as related to causality (i.e., reasonable possibility ) In contrast to current global practice Most conservative assessment by either investigator or sponsor accepted on case level for regulatory reporting sponsor assessment of causality of SAEs Evidence to suggest causal relationship In contrast to inability to rule out causal relationship Examples of evidence Single occurrence of event that is uncommon and known to be strongly associated with drug exposure E.g. Stevens Johnson Syndrome, angioedema 1 occurrences event not commonly associated with drug exposure, but otherwise uncommon in population exposed to durg E.g. tendon rupture Aggregate analysis of specific events in clinical trial: more frequent in treatment group than control group 11 DHCP Letters DHCP Letters: Improving Communication of Important Safety Information - Published November 2010 draft Drug Information Association

5 Highlights from Draft Guidance Overall Timelines Issuance: November 12, 2010 Purpose of this Guidance Provide recommendations on when to use a DHCP letter, the types of information to include in the letter, and formatting principles. Contents of Draft Guideline Which ARE in line with current practices FDA outlines three instances/types of DHCP letter Important Drug Warning Letter- Used to convey important new safety information in the BOXED WARNINGS, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS sections. Important Prescribing Information Letter- Used to convey important changes to the prescribing information such as changes to INDICATION AND USAGE, and DOSAGE and ADMINISTRATION sections. This DHCP letter should not be used to announce a new indication. Important Correction of Drug Information- Used to correct false or misleading information in prescription drug promotion labeling and advertisement that is the subject of a Warning Letter or other Agency action. Guidance defines the various sections of the letter and what information should be found in each. Each letter should clearly state the purpose of the letter, the new information, existing information that has changed, and outline action, if any, a HCP should take in response to the new information. Highlights from Draft Guidance Contents of Draft Guideline which are NOT in line with current practices FDA Consultation on Development of DHCP Letters FDA encourages consultation with review divisions for alignment on not only content/format, but also on decisions around the use of a DHCP to convey new information Target Audience for Initial Distribution FDA recommends manufacturers ensure the letter is directed to all HCPs who prescribe, dispense, administer i PLUS other providers for whom the information is pertinent (i.e., emergency departments and primary care physicians) Content and Format of DHCP Letters It is our best practice to include fair/balance statements on our DHCP Letters. This is not stressed as a requirement in the draft guidance Assessment of the DHCP Letter Impact FDA recommends an evaluation on 1) the extent to which target audiences are reached, 2) target audience's awareness of conveyed information and when appropriate, 3) the extent to which a DHCP changed the behavior of target audiences Key Feedback Challenging and costly to do so Unclear benefit for evaluations Would there be a review of AE reports to determine if HCPs prescribed product appropriately after DHCP Letter was issued? FDA needs to provide more guidance on the tools to be used Does this mean a field survey as a consequence of every DHCP letter? What is a good metric to use and what is a good score for that metric to determine if behavior has been changed or understanding of the issue was accomplished by the letter? How would the target audience be selected for evaluation of DHCP Letter impact using a risk-based approach? What would be appropriate sample size? Would prescribing patterns be used? Implications and burden also for the prescribing physician to be considered Incompleteness and biases in the data (physicians being aware of the letter and the required change in behavior) FDA wants to play a proactive role on the front end of letter development but seems to have no role on the back end. Ownership needs to be shared between MAH and FDA There would need to be agreement between the agency and the MAH on the target of such a survey: What would be considered success, what would require follow up actions? Which follow up actions? 5

6 Post-marketing Requirements Guidance for Industry Postmarketing Studies and Clinical Trials Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Final Published April 2011 Drug Information Association 16 Requirements for post-marketing studies and clinical trials Published April 2011 Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act types of postmarketing studies and clinical trials that: will generally be required under the new legislation l (postmarketing requirements (PMRs)) and will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials Drug Information Association 17 New FDAAA Authority and Requirements FDA May Require Applicants to Conduct Studies and Clinical Trials if FDA becomes aware of new safety information To assess a known serious risk related to the use of the drug To assess signals of serious risk related to the use of the drug To identify an unexpected serious risk when available data indicates the potential for a serious risk Applicants Are Required to Report on the Status of Studies and Clinical Trials Drug Information Association

7 Definition: New Safety Information a serious risk, or an unexpected serious risk associated with use of the drug including change in frequency or severity in the post-approval phase a risk it is serious, but may not enough knowledge to determine how to address the risk in labeling and what information would be appropriate to include. If there is information on chemically-related or pharmacologicallyrelated drugs, FDA may consider this drug class safety information when requiring a study or clinical trial Drug Information Association 19 Conditions for PMR 1. based on scientific data deemed appropriate by FDA, including information regarding chemically-related or pharmacologicallyrelated drugs; and 2. when FDA has found 1. before requiring a postmarketing study, that adverse event reporting and the new pharmacovigilance system that will be established will not be sufficient to meet the purposes described in condition 3 below; and 2. before requiring a postmarketing clinical trial, that a postmarketing study will not be sufficient to meet the purposes in condition 3 below; and 3. when the purposes of the study or clinical trial are one or more of the following: 1. To assess a known serious risk related to the use of the drug 2. To assess signals of serious risk related to the use of the drug 3. To identify an unexpected serious risk when available data indicates the potential for a serious risk Drug Information Association 20 Examples of Postmarketing Requirements Observational pharmacoepidemiologic studies Registries Meta-analyses Clinical trials with a safety endpoint Safety studies in animals in vitro laboratory safety studies Pharmacokinetic studies drug interactions or bioavailability Drug Information Association

8 Report on the Status a timetable for completion periodic reports on the status of the study, including whether any difficulties in completing the study have been encountered periodic reports on the status of the clinical trial whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information report on each study and clinical trial otherwise undertaken by the applicant to investigate a safety issue Drug Information Association 22 procedures FDA plans to inform the applicant of the planned target date for communication of feedback from the review division to the applicant regarding PMRs and PMCs in a letter sent within 14 days of the 60-day filing date of the marketing application. Generally, the designated planned target date will be no later than 1 month prior to the PDUFA goal date. FDA plans to communicate a list of potential PMRs and PMCs, clearly delineated d as to which h are required and which h may be agreed upon, to the applicant near the target date along with a brief rationale for why FDA thinks these studies and clinical trials are necessary. The applicant will have the opportunity to discuss the design and conduct of the PMRs and PMCs, as well as the overall goal, with the FDA review team. Drug Information Association 23 Drug Information Association

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