Recomendados
Recomendados
Mais conteúdo relacionado
Mais procurados
Mais procurados (20)
Destaque
Destaque (14)
Semelhante a Global Promotional Review Procedures
Semelhante a Global Promotional Review Procedures (20)
Global Promotional Review Procedures
- 1. Alan Bergstrom Senior Director, Commercial Regulatory Affairs ExL Pharma 2nd Promotional Review Committee Compliance & Best Practices October 27-28, 2014 Interpretation and Execution of Global Regulatory Procedures: Global Promotional Review
- 2. The content, views, and opinions in this presentation are my own and do not in anyway represent the views or opinions of Daiichi Sankyo, Inc.
- 3. 3 What is in Scope? All materials produced by the global marketing team •external – branded and unbranded •Internal – global brand books, global slide libraries Local country-specific material out of scope Presentation Name | CONFIDENTIAL
- 4. 4 Membership Global Promotional Review Committee (GPRC) Global Legal Global Medical Local Promotional Review Committee Local Legal Local Regulatory Local Medical Presentation Name | CONFIDENTIAL
- 5. 5 Review standards Global perspective Consistent with Company Core Data Sheet Scientifically accurate and truthful Not misleading Disclosure of product risk Well-documented, statistically and clinically or economically meaningful effect on a prospectively defined endpoint No off-label or preapproval promotion Presentation Name | CONFIDENTIAL
- 6. 6 Responsibility of Global Reviewers Global Medical – ensuring consistency with corporate core data sheet, scientifically accurate and substantiated, and fairly balanced Global Legal – support Global Medical review by ensuring consistency with corporate policy Presentation Name | CONFIDENTIAL
- 7. 7 Escalation Global Promotional Review Steering Committee (VP level) Global Medical Global Legal Global Marketing Presentation Name | CONFIDENTIAL
- 8. 8 Standards of Promotional Information International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Conduct Article 4.2 – Accurate and Not Misleading: …should be clear, legible, accurate, balanced, and sufficiently complete to enable recipient to form his or her own opinion of the therapeutic value… Article 4.3 – Substantiation: …either by reference to approved labeling or by scientific evidence. International Presentation Name | CONFIDENTIAL
- 9. 9 Standards of Promotional Information European Federation of Pharmaceutical Industries and Associations (EFPIA) HCP Code Article 3 Section 3.01 …must be accurate, balanced, fair, objective, and sufficiently complete to enable the recipient to form his or her own opinion… Section 3.02 …must be capable of substantiation Section 3.05 Any comparison made between products must be based on relevant and comparable aspects of the products. Regional Presentation Name | CONFIDENTIAL
- 10. 10 Standards of Promotional Information Association of the British Pharmaceutical Industry (ABPI) Code of Practice Clause 7.2 – must be accurate, balanced, fair, objective and unambiguous and must be based on an up- to-date evaluation of all the evidence Clause 7.3 – Comparisons allowed if not misleading; material, relevant, substantiable and representative features are compared; products of the same intended use or indication Local Presentation Name | CONFIDENTIAL
- 11. 11 Training IFPMA Code of Conduct Article 12 - Companies should establish and maintain appropriate procedures to ensure compliance with relevant codes and applicable laws - Companies should encourage that relevant employees receive training appropriate to their roles EFPIA HCP Code Section 18.02 – All company staff …who are concerned with the preparation or approval of promotional material or activities must be fully conversant with the requirements of the Applicable Code(s) and relevant laws and regulations Presentation Name | CONFIDENTIAL
- 12. 12 Training ABPI Code of Practice Clause 16 – All relevant personnel … concerned in any way with the preparation or approval of promotional material or information… must be fully conversant with the requirements of the Code and the relevant laws and regulations. Presentation Name | CONFIDENTIAL
- 13. 13 Regulatory Authority vs Self-Regulation Local Regulatory Authority Office of Prescription Drug Promotion (OPDP) in the U.S. or The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. Self-Regulatory Codes PhRMA in the U.S. – DTC Guiding Principles and Interactions with Healthcare Professionals Association of British Pharmaceutical Industry (ABPI) Codes of Practice Presentation Name | CONFIDENTIAL
- 14. 14 Self-Regulation IFPMA - responsible for administering complaints -validation of complaint - genuine matter submitted in good faith - sufficient information supplied - concerns a country where IFPMA code applies - not already under investigation by a member association -letter of complaint with supportive evidence sent by IFPMA to company -Inform company that a response is must be made normally within 30 days -Adjudication by ad hoc group normally within 30 days from receipt of company’s response -Complainant or respondent company may appeal within 30 days -Sanctions at a minimum to include confirmation that material no longer in use -Publication of case on IFPMA website Presentation Name | CONFIDENTIAL
- 15. 15 Self-Regulation EFPIA is conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. The EFPIA Code of Practice on the promotion of medicines to, and interactions, with Healthcare Professionals recognises the importance of voluntary control of advertising medicinal products by self-regulatory bodies and recourse to such bodies when complaints arise. Presentation Name | CONFIDENTIAL
- 16. 16 Self-Regulation The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry at arm’s length of the ABPI. The PMCPA is a not-for-profit body which was established by the ABPI on 1 January 1993. The PMCPA: •operates the complaints procedure under which the materials and activities of pharmaceutical companies are considered in relation to the requirements of the Code •provides advice and guidance on the Code •provides training on the Code •arranges conciliation between pharmaceutical companies when requested to do so •scrutinizes samples of advertising and meetings to check their compliance with the Code. PMCPA Letters Presentation Name | CONFIDENTIAL
- 17. 17 Resources International Comparative Legal Guide to: Pharmaceutical Advertising http://www.iclg.co.uk/practice-areas/pharmaceutical- advertising/pharmaceutical-advertising-2014 IFPMA Code of Practice http://www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-code-of- practice.html EFPIA HCP Code http://transparency.efpia.eu/uploads/Modules/Documents/efpia-hcp- code-2014.pdf ABPI Code of Practice http://www.abpi.org.uk/our-work/library/guidelines/Pages/The-Code-of- Practice-for-the-Pharmaceutical-Industry-2014.aspx Presentation Name | CONFIDENTIAL
- 18. 18 Thank you Questions? Presentation Name | CONFIDENTIAL
Notas do Editor
- Introduction – explain my background Poll – how many of the audience are involved in a Global Promotional Review Process. State that what I am about to present may be obvious to those who are involved. Explain being asked to present on topic - Localization of interpretation and execution of global corporate procedures; decentralization of the compliance recommendations from global HQ; advocate more market-specific compliance guidelines; identify and adapt to regulatory rends found in multiple market. Explain my struggle with this – I do not work in the global HQ but in what is now clearly the US subsidiary. Explain what i mean by that. While I oversee regulatory review at the Local, US – level, I have been drawn into influencing our global colleagues on how global review should be done. Explain a little about our company, lack of staffing in regards to Legal and Regulatory in Japan and Europe. Conclude with statement that this presentation then is really a little bit about both. Not so much on US process because that is covered, But imagine, you work for a company with a global presence, but no real global functions or understanding. How do you set up this process?
- My disclaimer as required by my company First let me ask how many of you in the audience are involved in a Global Review Process as opposed to a US- or local review process? Thank you. What I will be presenting in the following slides represents my impressions and opinions as I have been tasked with moving from a very specific focus on the US regulation of advertising and promotion in my first 8 years or so at DSI, to a more global approach and viewpoint over the last year. Those of you at large pharma companies may have much more experience at this but for those at smaller companies who are just beginning to develop a global review process may share some of the same experiences that I have. Please feel free to ask questions or offer your own experiences during my presentation.
- This may seem obvious but you would be surprised with the viewpoints from individuals who are new to a regulated global process. And in regards to global slide libraries which I include here, the distinction between proactive use and reactive use to an unsolicited request is relevant to the discussion. But from an ex-US perspective, and this is taken from the Association of the British Pharmaceutical Industry (ABPI) Code of Practice which you will hear more about later, promotion means any activity undertaken by a company which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of a product, including Journal and direct mail Activities of reps including detail aids and other printed material Samples Hospitality for promotional purposes Sponsorship pf scientific meetings Exhibits, use of audio and video, broadcast media, non-print media, internet, interactive data systems, etc. Obviously materials created for a specific local market are out of scope.
- Here I differentiate between the principle reviewers in a global process versus a local process. There will be representation from some editorial or process administration function and from global marketing or local marketing for instance as an initiator of the review process. Processes should be similar, just a difference in membership and review standards In general, I am advocating that the application of regulations be done at the local level by the local regulatory representative to the local review process. There are just too many local regulations for one individual reviewer to consider or be knowledgeable on. And given the circumstances of each company it may be necessary that global reviewers consult with their local counterparts. Some considerations, in a small company Not every local affiliate will have a legal group. A regional legal representative might exist for say all of Europe. May have to designate a reviewer with an awareness and understanding of drug promotion regulatory law. A local regulatory function whose role is to oversee the implementation of Ad promo regulations may not exist. This responsibility may reside in the commercial group or in marketing. As a result, the “global” legal reviewer may be consulting with either another lawyer or a regulatory representative as the situation requires.
- Review must be from a broad, global perspective. Forget your “local” hat. False and misleading – What is it? Cited by FDA in the CFR, and ABPI, EFPIA and IFPMA in their respective codes FDA cites 20 ways that claims are false, lacking in fair balance, and misleading and 13 ways they may be … ABPI, for example, cites eight Consistent with approved global labeling such as the core data sheet, i.e., a combined global view of labeling with local label deviations being reflected adequately
- The global medical reviewer is responsible for ensuring material is consistent with an approved global label such as the corporate core data sheet, and for ensuring a fair, scientifically accurate using the current medical and scientific information that is relevant, and a balanced presentation of the risks and benefits of the product and any competitor product. As touched on in an earlier slide, the Global Legal reviewer may consult with local legal or regulatory reviewers at the local level , including the US, EU countries , and Japan, for instance who have the local responsibility for the review of promotional materials, and will present a combined global view with local legal and/or regulatory deviations being reflected adequately at the global review. And as stated earlier local regulatory should implement the global direction based on local regulations. No one regulatory reviewer can be an expert in all national regulations. Differences exist which make this unreasonable to expect. (highlight some of those differences).
- IFPMA has membership of 30 pharmaceutical companies around the world with 50 associations operating in 50 different companies. IFPMA and affiliated associations complement laws, regulations and guidelines around the world. Code compliance is considered mandatory for member companies, as it is in affiliated associations except Switzerland where it is voluntary similar to PhRMA in the U.S.. Important to ensure that our global marketing counterparts and global reviewers are aware of the requirements and standards of IFPMA membership and of the affiliated associations as well.
- As mentioned earlier ABPI mentions 8 areas where care should be taken regarding misleading information, claims, and comparisons Claims of superiority based on weight are generally meaningless Use of data derived from in-vitro studies, healthy volunteers, and animals Referring to relative risk, as opposed to absolute risk, overstates efficacy Economic claims must be consistent with marketing authorization, supported by data and not an exaggeration of significance Balance in presentation of emerging clinical or scientific evidence Hanging comparisons, i.e., better or stronger without stating that with which the comparison is made Price comparisons must be accurate, fair, must not mislead and “like is compared with like”. Sound statistical basis for all information. Claims and comparisons.
- It has to be driven home to your global counterparts that training is an expectation of all Codes of Practice or Conduct.
- While in the US, we are regulated by FDA, and in other countries regulatory authoirities can exercise enforcement of regulations , in my experience most action is in the form of self-regulation. And while PhRMA guidelines are voluntary, the Codes of Practice are considered to be required by member companies (except Switzerland). If I could influence the global process it would be to enhance awareness of the expectations of membership in organizations such as IFPMA, EFPIA, and ABPI.
- While the IFPMA spells out the above self-regulatory process in general with 50 national associations IFPMA defers action to the national industry association.
- Important that global marketing and global reviewers are aware of and actually understand the complaints in these letters, These are important educational opportunities as the enforcement letters of OPDPO are considered to be.