Can We Transfer FDA Experience Into Latin America To Improve The Interaction With Health Authorities?

Transcription

1 Can We Transfer FDA Experience Into Latin America To Improve The Interaction With Health Authorities? 4th Latin American Congress of Clinical Research Global Initiatives of Clinical Research in Latin America São Paulo, BRAZIL 28 th Sept 2007 Session 4, 11:15 Peter Lassoff, Pharm.D. Vice President, Europe PAREXEL Consulting, London

2 - 2 - Agenda 1. Why interact with FDA? 2. Why interact with LA Health Authorities? 3. Meetings - Success Factor in Drug Development 4. Three Golden Rules for Meetings 5. FDA Meeting Lessons Applicable to Latin America 6. Latin American vs. FDA Meetings 7. Minutes and Follow-Up 8. PANDRH Future State of Drug Regulatory Affairs 9. Conclusions

3 - 3 - Why Interact with FDA? Educate FDA about product, development and clinical efforts, technical expertise, and introduce them to your company Facilitate a successful and fast review and approval (IND, NDA, etc) Address FDA concerns as early as possible Avoid delays due to need to correct or add to developmental plans Gain FDA buy-in on overall strategy Partner with FDA on complete development

4 Meetings with FDA During Early Drug Development Can Shorten Clinical Development Time Clinical development time (mos) Pre- IND Phase 1 Phase 2 End of Phase 2 Phase 3 No Meeting Meeting Source: DiMasi and Manocchia, DIA Journal 1997

5 Meetings with FDA During Early Drug Development Can Shorten NDA Review and Approval Time NDA Review Time (mos) Pre- IND Phase 1 Phase 2 End of Phase 2 Source: DiMasi and Manocchia, DIA Journal 1997 Phase 3 No Meeting Meeting

6 Scentific Advice Meetings with EMEA Improve Approval Rates ( ) Negative Outcome (negative opinion or withdrawal) From: EMEA/489472/ % 25% 20% 15% 10% 5% 0% With CHMP Scientific Advice (168 Applications) Without CHMP Scientific Advice (68 Applications) Negative Outcomes 19% 28%

7 - 7 - Why Interact with LA Authorities? Same reasons as for FDA! It is always better for companies to have a personal relationship with staff in regulatory authorities the personal touch means a lot anywhere in the world! LA large and growing market, 490 million people, 7.3% growth rate in Pharma sales Reduce assessment time for marketing authorisation applications, clinical study approvals, etc. With the right preparation, expectations and conduct for the meetings, very low risk and potentially high benefit

8 - 8 - Latin American Market Growth, Graph Source: IMS Health Pharma Prognosis Latin America,

9 - 9 - Meetings - Success Factor in Drug Development Maintain or create ongoing relationship Avoid misunderstandings Communicate new data Highlight and jointly resolve problems before they become too large Anticipate difficulties Monitor changes in Authority attitude or expectations of data Avoid surprising each other Accelerate development process

10 Three Golden Rules for Meetings (from FDA experience) 1. The Company must (almost) never ask open-ended questions. 2. It is the responsibility of the Company to think carefully about the issues and to present to the Authority proposed solutions for the issues, placing the Authority in a position to make a decision. 3. The Company then requests Authority agreement on the proposed solutions and, if necessary, negotiate compromise solutions.

11 FDA Meeting Lessons Applicable to Latin America DOs Be polite Be prepared Bring scientists Bring data Tell the truth Be clear Be reliable Know the players DON Ts Be rude or arrogant Waste time Bring CEO, lawyers Rely on charm Lie Be confusing Fail to follow through Rely on your politicians

12 Latin American vs. FDA Meetings FDA Legalistic, deal only with facts No advice offered, only comment on proposals from company Extremely formal, with minutes Very little discussion, basically FDA imparting their decisions to the company Latin America Free exchange of ideas Advice, discussion and commentary during meeting Can be informal, not always minuted Advice usually not binding on the company (but should not be ignored!) Binding advice

13 Minutes and Follow-Up FDA minutes are a binding agreement between FDA and the company Useful as a formal, permanent record of the meeting (but warning it is FDA s version of the meeting!) For Latin American meetings, the company should always send a short (1-2 pages) summary of the meeting with concise bullets of the main points Useful for the Agency as well as the company to have a record of the meeting BUT: this is not binding on either the Agency or the company (unlike FDA minutes) Even FDA has scope to wriggle out of agreements (new developments in science/technology etc.)

14 PANDRH Future State of Drug Regulatory Affairs Pan American Network on Drug Regulatory Harmonization Mission: to promote drug regulatory harmonization for all aspects of quality, safety, and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas New standards for GMP, GCP, interchangeability of products, etc. Meetings national or PANDRH in future? Similar to EU situation with national or EMEA/CHMP meetings

15 Conclusions Latin American markets are large and growing High growth for Pharma markets Major clinical site for Industry Professional interactions with LA Agencies needs to be mandatory for all companies operating in the area Experience with FDA shows that having the Agencies as partners in the drug development process speeds up development and improves the chances of success

16 Thank you! PAREXEL.com